Comparative Effectiveness Review
Number 186

Interventions
Targeting Sensory
Challenges in Children
With Autism Spectrum
Disorder­—An UpdateeComparative Effectiveness Review
Number 186

Interventions Targeting Sensory Challenges inChildren With Autism Spectrum Disorder—An Update
Prepared for:Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
www.ahrq.gov

Contract No. 290-2015-00003-I
Prepared by:Vanderbilt Evidence-based Practice Center
Nashville, TN
Investigators:
Amy S. Weitlauf, Ph.D.
Nila A. Sathe, M.A., M.L.I.S.
Melissa L. McPheeters, Ph.D., M.P.H.
Zachary Warren, Ph.D.

AHRQ Publication No. 17-EHC004-EF
May 2017

This report is based on research conducted by the Vanderbilt Evidence-based Practice Center(EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville,
MD (Contract No. 290-2015-00003-I). The findings and conclusions in this document are thoseof the authors, who are responsible for its contents; the findings and conclusions do notnecessarily represent the views of AHRQ. Therefore, no statement in this report should beconstrued as an official position of AHRQ or of the U.S. Department of Health and Human
Services.
None of the investigators have any affiliations or financial involvement that conflicts withthe material presented in this report.
The information in this report is intended to help health care decisionmakers—patients andclinicians, health system leaders, and policymakers, among others—make well-informed
decisions and thereby improve the quality of health care services. This report is not intended to
be a substitute for the application of clinical judgment. Anyone who makes decisions concerning
the provision of clinical care should consider this report in the same way as any medical
reference and in conjunction with all other pertinent information, i.e., in the context of available
resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between theauthor and the Agency for Healthcare Research and Quality. This report may be used andreprinted without permission except those copyrighted materials that are clearly noted in thereport. Further reproduction of those copyrighted materials is prohibited without the express
permission of copyright holders.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative
products that may be developed from this report, such as clinical practice guidelines, otherquality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

This report may periodically be assessed for the currency of conclusions. If an assessment isdone, the resulting surveillance report describing the methodology and findings will be found on
the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on thetitle of the report.
Persons using assistive technology may not be able to fully access information in this report. For
assistance contact EffectiveHealthCare@ahrq.hhs.gov.
Suggested citation: Weitlauf AS, Sathe NA, McPheeters ML, Warren Z. Interventions
Targeting Sensory Challenges in Children With Autism Spectrum Disorder—An Update.
Comparative Effectiveness Review No. 186. (Prepared by the Vanderbilt Evidence-based
Practice Center under Contract No. 290-2015-00003-I.) AHRQ Publication No. 17-EHC004EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2017.
www.effectivehealthcare.ahrq.gov/reports/final.cfm. doi: https://doi.org/10.23970/
AHRQEPCCER186.

ii

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based
Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- andprivate-sector organizations in their efforts to improve the quality of health care in the UnitedStates. These reviews provide comprehensive, science-based information on common, costly
medical conditions, and new health care technologies and strategies.
Systematic reviews are the building blocks underlying evidence-based practice; they focus
attention on the strength and limits of evidence from research studies about the effectiveness andsafety of a clinical intervention. In the context of developing recommendations for practice,systematic reviews can help clarify whether assertions about the value of the intervention are
based on strong evidence from clinical studies. For more information about AHRQ EPC
systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm.
AHRQ expects that these systematic reviews will be helpful to health plans, providers,purchasers, government programs, and the health care system as a whole. Transparency andstakeholder input are essential to the Effective Health Care Program. Please visit the Web site(www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an
email list to learn about new program products and opportunities for input.
If you have comments on this systematic review, they may be sent by mail to the Task Order
Officers named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane,
Rockville, MD 20857, or by email to epc@ahrq.hhs.gov.
Gopal Khanna, M.B.A.
Director
Agency for Healthcare Research and Quality

Arlene S. Bierman, M.D., M.S.
Director
Center for Evidence and Practice
Improvement
Agency for Healthcare Research and Quality

Stephanie Chang, M.D., M.P.H.
Director
Evidence-based Practice Center Program
Center for Evidence and Practice Improvement
Agency for Healthcare Research and Quality

Laura Pincock, Pharm.D., M.P.H.
Task Order Officer
Center for Evidence and Practice
Improvement
Agency for Healthcare Research and Quality
Elisabeth Kato, M.D., M.R.P.
Task Order Officer
Center for Evidence and Practice Improvement
Agency for Healthcare Research and Qualityiii

Acknowledgments
The authors gratefully acknowledge the following individuals for their contributions to thisproject: Ms. Jessica Kimber was an invaluable resource for assistance with data extraction andchecking, and helped to locate studies and track data. Ms. Katie Worley helped to extract dataand create tables. Drs. Mamata Raj and Jeff Andrews assisted with screening studies and withrisk of bias assessment. We sincerely appreciate their dedicated work as well as the input of our
Task Order Officers; Associate Editor, Margaret Maglione; and Key Informants and TechnicalExperts.

Key Informants
In designing the study questions, the EPC consulted several Key Informants who represent theend-users of research. The EPC sought the Key Informant input on the priority areas for researchand synthesis. Key Informants are not involved in the analysis of the evidence or the writing of
the report. Therefore, in the end, study questions, design, methodological approaches, and/or
conclusions do not necessarily represent the views of individual Key Informants.
Key Informants must disclose any financial conflicts of interest greater than $10,000 and anyother relevant business or professional conflicts of interest. Because of their role as end-users,
individuals with potential conflicts may be retained. The TOO and the EPC work to balance,
manage, or mitigate any conflicts of interest.
The list of Key Informants who provided input to this report follows:
Daniel Coury, M.D.*
Nationwide Children’s Hospital
Columbus, OH

Susan Levy, M.D., M.P.H.*
Children’s Hospital of Philadelphia
Philadelphia, PA

Jennifer Frost, M.D.
American Academy of Family Physicians
Leawood, KS

Tristram Smith, Ph.D.*
University of Rochester
Rochester, NY
Larry Wexler, Ph.D.
Oak Brook Psychology
Chicago, IL*Provided input on Draft Report.

iv

Technical Expert Panel
In designing the study questions and methodology at the outset of this report, the EPC
consulted several technical and content experts. Broad expertise and perspectives were sought.
Divergent and conflicted opinions are common and perceived as healthy scientific discourse that
results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design,
methodologic approaches, and/or conclusions do not necessarily represent the views ofindividual technical and content experts.
Technical Experts must disclose any financial conflicts of interest greater than $10,000 and anyother relevant business or professional conflicts of interest. Because of their unique clinical orcontent expertise, individuals with potential conflicts may be retained. The TOO and the EPC
work to balance, manage, or mitigate any potential conflicts of interest identified.
The list of Technical Experts who provided input to this report follows:
Grace Baranek, Ph.D.
University of North Carolina
Chapel Hill, NC

Susan Levy, M.D., M.P.H.*
Children’s Hospital of Philadelphia
Philadelphia, PA

Daniel Coury, M.D.*
Nationwide Children’s Hospital
Columbus, OH

Jeremy Veenstra-VanderWeele, M.D.*
Columbia University Medical Center
New York, NY

Jennifer Frost, M.D.
American Academy of Family Physicians
Leawood, KS

Paul Wang, M.D. ǂ
Simons Foundation
New York, NY

Susan Hyman, M.D.*
University of Rochester
Rochester, NY*Provided input on Draft Report.
ǂDr. Wang was affiliated with Autism Speaks at the time he served as a Technical Expert Panelmember and when he provided input on the Draft Report.

Peer Reviewers
Prior to publication of the final evidence report, EPCs sought input from independent Peer
Reviewers without financial conflicts of interest. However, the conclusions and synthesis of thescientific literature presented in this report do not necessarily represent the views of individual
reviewers.
Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and anyother relevant business or professional conflicts of interest. Because of their unique clinical orcontent expertise, individuals with potential nonfinancial conflicts may be retained. The TOOv

and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest
identified.
The list of Peer Reviewers follows:
Christian Gold, Ph.D.
GAMUT—The Grieg Academy Music Therapy Research Centre
Uni Research HealthBergen, Norway
Patricia Howlin, Ph.D.
Institute of Psychiatry, London
London, England, UKvi

Interventions Targeting Sensory Challenges inChildren With Autism Spectrum Disorder—An Update
Structured Abstract
Objectives. To evaluate the effectiveness and safety of interventions targeting sensory
challenges in children with autism spectrum disorder (ASD).
Data sources. We searched MEDLINE®, Embase®, the Cumulative Index of Nursing and Allied
Health Literature®, and PsycINFO® from January 2010 to September 2016.
Review methods. We included studies comparing interventions incorporating sensory-focused
modalities with alternative treatments or no treatment. Studies had to include at least 10 children
with ASD ages 2–12 years. Two investigators independently screened studies and rated risk ofbias. We extracted and summarized data qualitatively because of the significant heterogeneity.
We also assessed strength of the evidence (SOE).
Results. We identified 24 unique comparative studies (17 newly published studies and 7 studies
addressed in our 2011 review of therapies for children with ASD). Studies included 20
randomized controlled trials (RCTs), 1 nonrandomized trial, and 3 retrospective cohort studies (3low, 10 moderate, and 11 high risk of bias [ROB]). Populations, intervention approaches, andoutcomes assessed varied across studies. Relative to usual care or other interventions, sensory
integration–based approaches improved measures related to sensory and motor skills in the shortterm (3 RCTs with high, moderate, and low ROB and 1 high ROB retrospective cohort study).
Environmental enrichment improved nonverbal cognitive skills in treated children comparedwith standard care in two small RCTs (low and moderate ROB). Four small RCTs (2 moderate
and 2 high ROB) of auditory integration–based approaches reported mixed results. Studies ofmusic therapy (4 RCTs—1 low, 2 moderate, and 1 high ROB—and 1 high ROB nonrandomized
trial) used different protocols and addressed different outcomes, precluding synthesis. Massage
improved ASD symptom severity and sensory challenges versus a waitlist control condition (7studies, 5 with likely overlapping participants, 3 moderate and 4 high ROB). Additional RCTs
(moderate and high ROB) of interventions with sensory-related components (tactile stimulation
exercises, weighted blankets) reported few significant differences between treatment groups.
Conclusions. Some interventions targeting sensory challenges may produce modest short-term(<6 months) improvements, primarily in sensory-related outcomes and outcomes related to ASD
symptom severity; however, the evidence base for any category of intervention is small, anddurability of effects beyond the immediate intervention period is unclear. Sensory integration–
based approaches improved outcomes related to sensory challenges (low SOE) and motor skills(low SOE), and massage improved sensory responses (low SOE) and ASD symptoms (lowSOE). Environmental enrichment improved nonverbal cognitive skills (low SOE). Auditory
integration–based approaches did not improve language outcomes (low SOE). Some positiveeffects were associated with other approaches studied (music therapy, weighted blankets), butfindings in these small studies were not consistent (insufficient SOE). Data on longer term
results are lacking, as are data on characteristics that modify outcomes, effectiveness ofinterventions across environments or contexts, and components of interventions that may driveviieffects. In sum, while some therapies may hold promise and warrant further study, substantial
needs exist for continuing improvements in methodologic rigor in the field.

viii

Contents
Introduction ....................................................................................................................................1
Background ................................................................................................................................1
Treatment of ASD ................................................................................................................1
Scope and Key Questions ..........................................................................................................2
Scope of Review ..................................................................................................................2
Key Questions ......................................................................................................................2
Categorization of Interventions............................................................................................3
Analytic Framework ..................................................................................................................4
Uses of This Evidence Report....................................................................................................5
Methods ..........................................................................................................................................6
Topic Surveillance and Review Protocol ...................................................................................6
Literature Search Strategy..........................................................................................................7
Search Strategy ....................................................................................................................7
Inclusion and Exclusion Criteria..........................................................................................7
Study Selection ....................................................................................................................8
Data Extraction ....................................................................................................................8
Data Synthesis ............................................................................................................................8
Risk of Bias Assessment of Individual Studies .........................................................................9
Determining Overall Risk of Bias Ratings ................................................................................9Applicability ..............................................................................................................................9
Strength of the Body of Evidence ................................................................................................
Peer Review and Public Commentary .....................................................................................10
Results ..........................................................................................................................................11
Results of Literature Searches for Key Questions ...................................................................11
Description of Included Studies .........................................................................................12
Gray Literature ...................................................................................................................13
Key Question 1. Benefits and Harms of Interventions Targeting Sensory Challenges ...........13
Studies of Sensory Integration-Based Approaches ............................................................13
Studies of Environmental Enrichment-Based Approaches ................................................15
Studies of Auditory Integration-Based Approaches ..........................................................16
Studies of Music Therapy-Based Approaches ...................................................................17
Studies of Touch/Massage .................................................................................................18
Additional Studies..............................................................................................................21
Key Question 2. Modifiers of Treatment Outcomes ................................................................21
Key Question 3. Time to Effect of Interventions .....................................................................22
Key Question 4. Evidence That Effects Measured at the End of Treatment Predict LongTerm Functional Outcomes......................................................................................................22
Key Question 5. Effectiveness Across Environments or Contexts ..........................................23
Key Question 6. Drivers of Treatment Outcomes ...................................................................23
Discussion .....................................................................................................................................24
State of the Literature...............................................................................................................24
Summary of Key Findings and Strength of the Evidence........................................................24
Key Question 1. Benefits and Harms of Interventions Targeting Sensory Challenges .....24
Other Key Questions ..........................................................................................................29
Findings in Relation to What Is Already Known...............................................................29ix

Applicability ............................................................................................................................31
Implications for Clinical and Policy Decisionmaking .............................................................32
Limitations of the Comparative Effectiveness Review Process ..............................................32
Limitations of the Evidence Base ............................................................................................33
Research Gaps and Areas for Future Research ........................................................................34
Conclusions ..............................................................................................................................35
References ....................................................................................................................................36
Acronyms and Abbreviations ....................................................................................................40
TablesTable 1. Inclusion criteria ................................................................................................................8
Table 2. Overview of studies addressing interventions targeting sensory challenges ...................12
Table 3. Overview of key outcome areas targeted .........................................................................13
Table 4. Strength of the evidence for sensory integration-based interventions versus control
approaches......................................................................................................................................25
Table 5. Strength of the evidence for environmental enrichment interventions versus usual care26
Table 6. Strength of the evidence for auditory integration-based interventions versus control
approaches......................................................................................................................................27
Table 7. Strength of the evidence for massage-based interventions versus waitlist control
conditions .......................................................................................................................................28
FiguresFigure 1. Analytic framework for review ........................................................................................5
Figure 2. Disposition of studies identified for this review ............................................................11
Appendixes
Appendix A. Detailed Methods
Appendix B. Search Strategies
Appendix C. Screening and Quality Assessment Forms
Appendix D. Excluded Studies
Appendix E. Risk of Bias Ratings
Appendix F. Applicability of Findings
Appendix G. Detailed Table of FindingsxIntroduction
Background
Autism spectrum disorder (ASD) is a neurodevelopmental disorder broadly defined by
impaired social communication as well as restricted or repetitive patterns of behavior andinterest. As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition(DSM-5), specific features of ASD include deficits in social and emotional reciprocity (e.g.,
atypical social approaches, conversational impairment, atypical sharing of interests, attention,
and affect); deficits in nonverbal communication (e.g., poorly integrated verbal and nonverbal
communication, atypical body-language and gesture use, deficits in use and understanding of
nonverbal communication); and deficits in maintaining appropriate relationships (e.g., challenges
with peer interest, vulnerabilities forming friendships, difficulties adjusting behavior to suit
social contexts) as well as restricted and repetitive patterns of behavior such as stereotyped
speech, motor movements, or use of objects; excessive adherence to routine or insistence on
sameness; intense interest patterns; and atypical sensory interests or responses.1 Symptoms of thedisorder impair and limit everyday functioning and are thought to be evident in early childhood,
although they may not be fully evident until later ages. Although not a core symptom, many
children with ASD may also have significant cognitive impairment.
Children with ASD may experience impairments in processing sensory stimuli, including
intense interests in or aversion to certain types of sensory input; while somewhat challenging tooperationalize, quantify, and measure clinically, estimates of impairments related to sensory
processing have ranged from 42 percent to 88 percent of people with ASD and include both
hyper- and hypo-responsiveness.2-4 Though sensory challenges are common and impairingfeatures of ASD for many individuals, the exact nature of sensory integration in the development
and lifespan trajectory is less understood. The field has historically lacked accepted frameworks
for diagnosing sensory challenges (e.g., not part of DSM diagnostic criteria until DSM-5) anddeveloping responsive interventions.2, 3, 5, 6

Treatment of ASD
The manifestation and severity of symptoms of ASD differ widely, and treatments include a
range of behavioral, psychosocial, educational, medical, and complementary approaches7-10 thatvary by a child’s age and developmental status. The goals of treatment for ASD typically focus
on improving core deficits in communication, social interactions, or restricted behaviors, aschanging these fundamental deficits may help children develop greater functional skills andindependence.11 Treatment frequently is complicated by symptoms or comorbidities that may
warrant targeted intervention. There is no cure for ASD and no global consensus on whichintervention is most effective.12, 13 Individual goals for treatment vary for different children andmay include combinations of behavioral therapies, educational therapies, medical and related
therapies, approaches targeting sensory issues, and allied health therapies; parents may also
pursue complementary and alternative medicine therapies.

Interventions Targeting Sensory Challenges
Increasingly, as reflected in their inclusion in the new DSM-5 diagnostic criteria, the sensory
challenges associated with ASD have also become a target for specialized assessment andtreatment. Sensory symptoms can involve both strong interests as well as strong aversions, with1

interventions commonly targeting aversions/challenges, meeting needs for sensory input within
adaptive frameworks, or perceived processing deficits with the goal of improving people’sabilities to interact with their environments. For example, a child with ASD may have difficultytolerating bright lights, clothing or food textures, specific noises (such as a baby crying), tasks ofdaily living (such as brushing hair or teeth), touch, or more idiosyncratic stimuli such as certain
colors. These sensitivities can significantly interfere with children’s ability to care forthemselves, leave the home, participate in school or other interventions, and be involved in social
situations. Children may also display a hyperfocus on play or activities that involves a sensory
component, sometimes referred to as ”sensory-seeking” or ”stimming” behaviors.
Sensory-focused interventions take a variety of forms and can be implemented by a variety oflicensed professionals (such as occupational therapists), teachers, parents, and other providers.
Such interventions are not consistently defined but typically involve the incorporation of sensory
experiences (e.g., weighted clothing or materials, interventions that provide auditory sensations)to affect a variety of outcomes including adaptive behavior and language.

Scope and Key Questions
Scope of Review
This review updates findings reported in the 2011 Agency for Healthcare Research andQuality (AHRQ) review Therapies for Children with ASD14 with a focus on studies ofinterventions targeting sensory challenges. We defined interventions targeting sensory challenges
in line with the DSM-5 definition and definitions used in other reviews of sensory-focusedinterventions.2, 3 DSM-5 classifies sensory challenges as a manifestation of the core symptom of
restricted and repetitive patterns of behavior, interests, or activities. The DSM describes sensory
challenges as “hyper- or hyporeactivity to sensory input, manifested through extreme responses
to specific sounds or textures, excessive smelling or touching of objects, fascination with lights
or spinning objects, and sometimes apparent indifference to pain, heat, or cold.”1 Interventions
targeting sensory challenges are typically described as designed to provide controlled sensory
experiences in order to encourage the modulation and integration of information from theenvironment, thus promoting adaptive responses to sensory inputs.
Though the field lacks broad consensus on a definition of sensory-focused approaches,interventions typically use sensory modalities to target behaviors that may be associated withsensory-related impairments.3, 15 We do not include studies of other approaches (e.g., educational
interventions) that may address a sensory-related outcome in the current review. A companion
review updating findings related to medical interventions is available on the AHRQ Effective
Health Care Web site.

Key Questions
We developed Key Questions (KQs) in consultation with Key Informants and the Task Order
Officer. KQs were posted for review to the AHRQ Effective Health Care Web site.
KQs were as follows:

KQ1: Among children ages 2-12 with ASD, what is the comparative
effectiveness (benefits and harms) of interventions targeting sensory
challenges?
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a. What are the effects on core symptoms (e.g., deficits in social
communication and interaction; restricted, repetitive patterns of
behavior, interests, or activities including hyper- or hypo- reactivity tosensory input or unusual interest in sensory aspects of the environment)in the short term (<6 months)?
b. What are the effects on commonly associated symptoms (e.g., motor,
medical, mood/anxiety, irritability, and hyperactivity) in the short term (<6months)?
c. What are the longer term effects (≥6 months) on core symptoms (e.g.,social deficits, communication deficits, and repetitive behaviors)?
d. What are the longer term effects (≥6 months) on commonly associatedsymptoms (e.g., motor, medical, mood/anxiety, irritability, andhyperactivity)?
KQ2: Among children ages 2-12 with ASD, what are the modifiers ofoutcome for different interventions targeting sensory challenges?
a. Is the effectiveness of the therapies reviewed affected by the frequency,
duration, intensity, or dose of the intervention?
b. Is the effectiveness of the therapies reviewed affected by cointerventions or prior treatment, or the training and/or experience of theindividual providing the therapy?
c. What characteristics (e.g., age, symptom severity), if any, of the childmodify the effectiveness of the therapies reviewed?
d. What characteristics, if any, of the family modify the effectiveness of thetherapies reviewed?
KQ3: What is the time to effect of interventions targeting sensory
challenges?
KQ4: What is the evidence that effects measured at the end of thetreatment phase predict long-term functional outcomes of interventions
targeting sensory challenges?
KQ5: Is the effectiveness of interventions targeting sensory challenges
maintained across environments or contexts (e.g., people, places,materials)?

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KQ6: What evidence supports specific components of treatment withinterventions targeting sensory challenges as driving outcomes, either
within a single treatment or across treatments?

Categorization of Interventions
Interventions targeting sensory challenges may be broadly categorized by their core focus(e.g., environmental modification/adaptation, compensatory strategies, sensory processing,auditory integration). However, frequently these categories of sensory-related approaches
include overlapping targets and intervention strategies, as well as unique and differing aspects ofthe same constructs. As such it is extremely challenging to identify definitively the category into
which many offered interventions should be placed. With input from our clinical experts, wecategorized approaches based on the core strategies used in each intervention. In some cases thisapproach grouped together interventions that may have used specific, manualized techniqueswith others that used only a subset of those techniques (e.g., Ayres-based sensory integration andsensory integration models that may have used some Ayres strategies). We note that noalternative approaches (e.g., considering Ayres-based approaches and other sensory integration
approaches as separate categories) would have substantially changed our overall findings interms of strength of evidence.
Based on the literature meeting criteria for this review, we categorized interventions as:• Sensory integration-based (interventions using combinations of sensory and kinetic
components such as materials with different textures, touch/massage, swinging andtrampoline exercises, and balance and muscle resistance exercises to ameliorate sensory
challenges)• Environmental enrichment-based (interventions incorporating targeted exposure to sensory
stimuli to promote tolerance of stimuli in other contexts)• Auditory integration-based (interventions incorporating auditory components such as filteredsound to ameliorate sensory processing challenges via theorized re-training of auralpathways)• Music therapy-based (interventions incorporating playing or singing music, or movement tomusic, to improve challenging behaviors and sensory difficulties)• Touch/Massage-based (interventions incorporating touch-based approaches by a therapist or
caregiver)• Other (included interventions [tactile-based tasks, weighted blankets] not cleanly fitting into
one of the broader categories).
We recognize that other approaches to categorizing interventions targeting sensory
challenges could be used.

Analytic Framework
The analytic framework (Figure 1) illustrates the population, interventions, outcomes, andadverse effects that guide the literature search and synthesis.

4Figure 1. Analytic framework for review

ASD=autism spectrum disorder; KQ=Key Question

Uses of This Evidence Report
We anticipate that the report will be of value to clinicians who treat children with ASD, who
can use the report to assess the evidence for different treatment strategies. In addition, thisreview will be of use to the National Institutes of Health, U.S. Centers for Disease Control andPrevention, Centers for Medicare & Medicaid Services, and the Health Resources and Services
Administration–all of which have offices or bureaus devoted to child health issues and who may
use the report to compare treatments and determine priorities for funding. This report can bringpractitioners up to date about the current state of evidence related to interventions targeting
sensory challenges, and it provides an assessment of the risk of bias of studies that aim todetermine outcomes of sensory-related options for the management of ASD. It will be of interest
to families affected by ASD because of the recurring need for families and their health careproviders to make the best possible decisions among numerous options. We also anticipate it will
be of use to private sector organizations concerned with ASD; the report can inform suchorganizations’ understanding of the effectiveness of treatments and the amount and quality ofevidence available. Researchers can obtain a concise analysis of the current state of knowledge
related to interventions targeting sensory challenges in ASD and of areas for future research.

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Methods
In this chapter, we briefly outline the procedures that we used to produce a Comparative
Effectiveness Review (CER) update addressing interventions targeting sensory challenges forchildren with autism spectrum disorder (ASD). Appendix A includes a more detailed discussionof our methods. These procedures follow the methods outlined in the Agency for Healthcare
Research and Quality (AHRQ) Effective Health Care Program Methods Guide for Effectivenessand Comparative Effectiveness Reviews.16

Topic Surveillance and Review Protocol
The topic for the original report14 was nominated by Autism Speaks in a public process using
the Effective Health Care Web site. AHRQ published an update addressing behavioral
interventions in 2014.17 We conducted a surveillance process to assess the need to update thereport by contacting topic experts about the relevance of the Key Questions (KQs) and new
evidence that may address them. All members of the research team were required to submit
information about potential conflicts of interest before initiation of the work. No members of thereview team had any conflicts.
In consultation with clinical experts and stakeholders, and based on our preliminary scan of
the literature and surveillance findings, we focused the review update on approaches to address
sensory challenges and medical approaches (reported in a separate update). These areas reflect
both areas of clinical relevance and sufficient newly published literature for a review update.
Given the different major emphases of these interventions (i.e., sensory processing/integration
abilities and challenging behaviors) and subsequent differences in study populations, we reportfindings in two separate reviews.
Based also on the surveillance process and discussions with stakeholders, we revised the KQ
addressed in the 2011 report to reflect the focus on medical and sensory approaches specifically.
We also eliminated a question on approaches for children at risk for ASD as such children areunlikely to be included in studies in the target areas for this review update.
After review from AHRQ, the questions and framework were posted online for publiccomment. No changes to the questions or framework were recommended. We identified
technical experts on the topic to provide assistance during the project. The Technical Expert
Panel (TEP), representing the fields of pediatrics and developmental pediatrics, psychiatry,family medicine, and occupational therapy and allied health, contributed to the AHRQ’s broader
goals of (1) creating and maintaining science partnerships as well as public-private partnerships
and (2) meeting the needs of an array of potential users of its products. Thus, the TEP was bothan additional resource and a sounding board during the project. The TEP included sevenmembers serving as technical or clinical experts. To ensure robust, scientifically relevant work,
TEP members participated in conference calls to:• Help to refine the analytic framework and KQ at the beginning of the project;• Discuss inclusion/exclusion criteria; and• Assist with determining key interventions and outcomes of interest.
The final protocol was posted to the AHRQ Effective Health Care Web site and registered in
the PROSPERO international register of systematic reviews (ID#: CRD42016033941).

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Literature Search Strategy
Search Strategy
To ensure comprehensive retrieval of relevant studies of therapies for children with ASD, weused four key databases: the MEDLINE® medical literature database via the PubMed® interface;
EMBASE (Excerpta Medica Database), an international biomedical and pharmacologicalliterature database via the Ovid® interface; the Cumulative Index of Nursing and Allied Health
Literature (CINAHL), and PsycINFO®. Search strategies for KQs applied a combination ofcontrolled vocabulary (Medical Subject Headings [MeSH] and Emtree headings) to focus
specifically on interventions targeting sensory challenges in children with ASD and harms ofinterventions (Appendix B). We restricted literature searches for KQs to studies published from2010 to September 2016 to reflect literature available since the publication of the 2011 review.

Gray Literature
We searched Web sites of organizations likely to conduct research, issue guidance, or
generate policies for ASD (e.g., Autism Speaks, the American Academy of Child and Adolescent
Psychiatry) to inform the review’s background and discussion sections. We searched governmentand regulatory agency Web sites for contextual information on benefits and harms of ASD
interventions. We searched ClinicalTrials.gov, the International Standard Randomized
Controlled Trials Number (ISRCTN) registry, and other trial registries for information about
relevant ongoing trials and to confirm that we have obtained available publications of resultsfrom completed trials.

Inclusion and Exclusion Criteria
Table 1 outlines inclusion criteria. We required that eligible randomized controlled trials(RCTs) have a total minimum sample size of 10. We required a higher minimum sample size
(n=20) for other comparative studies as they typically have fewer controls for bias than RCTs.
We recognize that these study design criteria excluded single-subject or single-case experimental
designs that have been used to study interventions targeting sensory challenges. These studies arechallenging to incorporate in a meaningful way in comparative effectiveness reviews, whichattempt to evaluate the effectiveness of interventions at the population level. To mitigate theexclusion of such studies; however, we include summaries of recent reviews that have included
such studies and discuss our findings in light of those in other reviews (see Findings in Relation
to What Is Already Known).
We included studies published in English only. In the opinion of our content experts, muchof the relevant literature on ASD is published in English. We focused the review on children
between 2 and 12 years of age. We chose to limit the age range to this span because a) diagnosis
of ASD earlier than age 2 is less established and b) adolescents likely have substantially different
challenges and would warrant different interventions than children in the preschool, elementaryand middle school age groups. Studies also included only children with a diagnosis of ASD (ordata reported separately for children with ASD).

7

Table 1. Inclusion criteria
Category

Criteria

Study Population

Children ages 2-12 with ASD (mean age plus standard deviation is ≤ 12 years and 11
months)Publication Languages

English only

Admissible Evidence(study design and othercriteria)

Admissible designs
Randomized controlled trials, prospective and retrospective cohort studies withcomparison groups, and nonrandomized controlled trials
Other criteria
Original research studies published from 2010—present and not addressed in priorreviews
Studies must have relevant population and ≥20 participants with ASD (non-RCTs) or atleast 10 total participants (RCTs)

Studies must address one or more of the following for ASD:
-Outcomes of interest-Treatment modality of interest-Predictors or drivers of treatment outcomes (e.g., biomarkers, clinical changes)-Maintenance of outcomes across environments or contexts-Sufficiently detailed methods and results to enable data extraction-Reporting of outcome data by target population or intervention
ASD=autism spectrum disorder; RCT=randomized controlled trial

Study Selection
Two reviewers separately evaluated the abstracts of studies identified in our searches for
KQs for inclusion or exclusion, using an Abstract Review Form (Appendix C). If one reviewer
concluded that the article could be eligible for the review based on the abstract, we retained it.
Following abstract review, two reviewers independently assessed the full text of each included
study using a standardized form (Appendix C) that included questions stemming from our
inclusion and exclusion criteria. A senior reviewer resolved disagreements between reviewers.
Appendix D includes a list of excluded studies and the reasons for exclusion. Data extracted foreach study are available via the Systematic Review Data Repository (http://srdr.ahrq.gov/).

Data Extraction
We designed extraction forms to provide sufficient information to enable readers to understandthe studies and to determine their quality; we gave particular emphasis to essential information
related to the KQs. Team data extractors shared the task of initially entering information into theevidence tables. A second team member also reviewed the articles and edited all initial entries
for accuracy, completeness, and consistency. A senior reviewer reconciled disagreements
concerning the information reported.

Data Synthesis
Studies were too heterogeneous to allow for meta-analyses. We summarized data for Key
Questions qualitatively using summary tables.

8

Risk of Bias Assessment of Individual Studies
We evaluated the overall methodologic risk of bias of individual studies using the ASDspecific assessment approach developed and used in our prior reviews of interventions for ASD
and informed by the Methods Guide for Effectiveness and Comparative Effectiveness Reviews.16
We developed this tool because standard risk of bias assessment tools (e.g., Cochrane risk of bias
assessment) do not fully account for the complexity of interventions and populations represented
in the ASD literature. Specifically, the tool includes questions to address diagnostic approaches
and measures of treatment fidelity that may affect outcomes. The tool has not been formallyvalidated.
Two senior investigators assessed each included study independently with disagreements
resolved through discussion. Appendix C includes our risk of bias assessment form, andAppendix E includes the risk of bias ratings for each study. Appendix A includes additional
details about our risk of bias approach.

Determining Overall Risk of Bias Ratings
We used the thresholds we established in prior reviews to assess overall high, medium or low
risk of bias. We assessed the risk of bias based upon the study-defined primary outcome(s). We
assessed each domain described above individually and considered the individual ratings todetermine an overall quality assessment of low, moderate, or high risk of bias. Appendix A
includes additional details.

Applicability
We assessed the applicability of findings reported in the included literature addressing our
KQs to the general population of children with ASD by determining the population, intervention,comparator, and setting in each study and developing an overview of these elements for eachintervention category. We anticipated that areas in which applicability would be especially
important to describe would include ASD severity, comorbidities, age at treatment, andintervention characteristics such provider, dosing/intensity, and setting. Applicability tables foreach KQ are in Appendix F.

Strength of the Body of Evidence
The assessment of the literature is done by considering both the observed effectiveness ofinterventions and the confidence that we have in the stability of those effects in the face of future
research (see Appendix A for full details). The degree of confidence that the observed effect of
an intervention is unlikely to change is presented as strength of evidence. Methods for applying
strength of evidence assessments are established in the Methods Guide for Effectiveness andComparative Effectiveness Reviews16 and are based on consideration study limitations,consistency in direction of the effect, directness in measuring intended outcomes, precision ofeffect, and reporting bias. Strength of evidence is assessed separately for major interventionoutcome pairs and incorporates data from the entire body of reviewed evidence on behavioral
interventions (i.e., comparative studies—both RCTs and prospective and retrospective cohort
studies—reported in the 2011 review14 and studies reported in the current review). The possible
strength of evidence grades were:9• High: High confidence that the evidence reflects the true effect. Further research isunlikely to change estimates• Moderate: Moderate confidence that the evidence reflects the true effect. Further research
may change our confidence in the estimate of effect and may change the estimate• Low: Low confidence that the evidence reflects the true effect. Further research is likely tochange confidence in the estimate of effect and is also likely to change the estimate• Insufficient: Evidence is either unavailable or does not permit a conclusion.

Peer Review and Public Commentary
Researchers and clinicians with expertise in treating children with ASD and individuals
representing stakeholder and user communities provided external peer review of this report. The
draft report was posted on the AHRQ Web site for 4 weeks to elicit public comment. We
addressed all reviewer comments, revised the text as appropriate, and documented changes andrevisions to the report in a disposition of comments report that will be made available 3 months
after AHRQ posts the final review on the AHRQ Web site.

10Results
Results of Literature Searches for Key Questions
We identified 6573 nonduplicative titles or abstracts with potential relevance, with 485
proceeding to full text review (Figure 2). We excluded 468 studies at full text review. We
included 17 unique studies (17 publications; one publication reports two separate studies18 andone study was reported in two papers19, 20) in the review. These 17 studies included 13
randomized controlled trials (RCTs), one nonrandomized trial, and three retrospective cohort
studies. In addition to these 17 studies published since the completion of our original review oftherapies for children with autism spectrum disorder (ASD) in 2011,14 we include sevencomparative studies addressed in the 2011 review in order to present a comprehensive
assessment of the literature addressing interventions targeting sensory challenges.
Figure 2. Disposition of studies identified for this review

Numbers next to each Key Question indicate number of unique studies addressing the question. Studies could address more than
one Key Question.
*Numbers do not tally as studies could be excluded for multiple reasons.
†One paper reports two separate trials. We also include analysis of 7 comparative studies reported in our 2011 review oftherapies for children with ASD; thus, we describe a total of 24 studies.
Abbreviations: KQ = Key Question; n = number.

11Description of Included Studies
The 24 studies addressing interventions targeting sensory challenges included 20 RCTs
(including one paper that reported two separate studies18-37 one nonrandomized trial, 38 and three
retrospective cohort studies39-41 (Table 2). Three studies had low risk of bias,22, 24, 37 10 had
moderate,19-21, 23, 25, 27, 28, 33-36 and 11 had high risk.18, 26, 29-32, 38-41 Fourteen studies were conductedin the United States,18-26, 29, 33, 34, 36, 40 two in the UK,28, 35 two in Korea,30, 41 and one each inJapan,39 Iran,38 Turkey,31 Brazil,37 Thailand,32 and Australia.27
In total, studies included approximately 1010 children (median 34 total children/study)
ranging in age from 2 to 16 years. Overlap of participants in a series of massage-focused studies
by one investigative team is unclear. While studies likely included some of the same children,
the extent of overlap is not clear.25, 26, 33, 36, 40
Severity of ASD and sensory dysfunction varied across studies. Only two studies reported
any followup of participants after the completion of treatment,26, 38 and one had more than 6months of treatment39 while another planned for 5 months of treatment but required 7 months tocomplete the intervention.37 Because few studies addressed sub-questions under Key Questions(KQ) 1 and 2, we present results in the aggregate under each of these KQ. Appendix G includes
detailed summary tables summarizing key outcomes.

RCTs (n=20)

Nonrandomized
Trials (n=1)

Retrospective
Cohort Studies(n=3)

Total Literature

Table 2. Overview of studies addressing interventions targeting sensory challenges

Sensory integration-based approaches
Environmental enrichment-based approaches
Auditory integration-based approaches
Music therapy-based approaches
Massage-based approaches
Additional approaches
Treatment Duration<1-4 weeks
5-8 weeks9-12 weeks
13-20 weeks≥21 weeks
Region of Study Conduct

3
2
4
4
5
2

0
0
0
1
0
0

1
0
0
0
2
0

4
2
4
5
7
2

5
2
4
6
3

1
0
0
0
0

0
0
0
2
1

6
2
4
8
4

Asia
Australia
EuropeNorth America
South America
Risk of Bias
Low
Moderate
High
Total N Participants
N = Number; RCT = Randomized Controlled Trial

3
1
2
13
1

1
0
0
0
0

2
0
0
1
0

6
1
2
14
1

3
10
7
790

0
0
1
27

0
0
3
193

3
10
11
1010

Characteristic
Intervention Category

12Table 3 outlines outcome areas targeted in studies meeting our review criteria. Most studies
addressed sensory challenges and symptom severity.

26, 32, 33, 36, 40, 41

X

X

X

X

X

X

X

X

X

X

Harms ofIntervention

Sleep

X

Adaptive
Behavior

X

Challenging
Behaviors

Nonverbal
Cognitive Skills

X

SocialEngagement

X

Language/
Communication

Sensory
Challenges

Intervention/ Outcomes
Targeted
Sensory Integration-based
Approaches21, 22, 31, 39
Environmental enrichmentbased Approaches23, 24
Auditory Integration-based
Approaches18, 34, 35
Music Therapy19, 20, 27, 30, 37, 38
Massage-based Approaches25,

ASD Symptom
Severity

Table 3. Overview of key outcome areas targeted

X

X
X
X
X

X

Tactile-based Task29
X
X
Weighted Blanket28
X
X
ASD= autism spectrum disorder
Note: X=Outcome area addressed by a study in the intervention category noted

X

X

X

X

Gray Literature
Our searches of ClinicalTrials.gov and other trial registries did not yield additional eligible
studies for the review. We used information from organization Web sites searched to provide
additional context for the discussion section of the report.

Key Question 1. Benefits and Harms of Interventions
Targeting Sensory Challenges
Studies of Sensory Integration-Based Approaches
Key Points• Four studies addressing sensory integration (SI)-based approaches were small and short-term(typically <6 months), with no followup beyond the immediate treatment period. No study
reported harms of intervention.
• Sensory-related outcomes improved in children receiving an SI-based intervention comparedwith those receiving usual care or other treatment (statistically significant improvements inthree of four studies addressing the outcome). We have low confidence in this conclusion (lowstrength of evidence).
• Motor skills outcomes were improved in children receiving SI-based treatment compared withthose receiving usual care or other treatment (statistically significant improvements in three ofthree studies addressing the outcome). We have low confidence in this conclusion (lowstrength of evidence).

13

• We could not assess the effects of SI-based treatment on adaptive behavior given differencesin outcomes measures (insufficient strength of evidence).

Overview of the Literature
We identified three RCTs (one low,22 one moderate,21 and one high31 risk of bias) and one
retrospective cohort study (high risk of bias39) addressing SI-based approaches. These studies
included one RCT with high risk of bias addressed in our 2011 review.31 All four studies
included either explicitly noted that they were based on Ayres sensory integration principles21, 22
or noted using a coordinated program of specific sensory-based activities selected based on agiven child's needs and incorporated into the child's daily routine.31, 39 Studies were conducted in
the United States,21, 22 Japan,39 and Turkey31 and included a total of 119 children between theages of 2 to 12 years. Treatment duration ranged from 6 weeks to 10 months, and no study
reported long-term followup after the end of treatment.

Detailed Analysis
In these small, short-term studies, outcomes on sensory-related measures and motor skills
measures were improved in children receiving a SI-based intervention compared with anotherintervention in three of four studies, but effects on other outcomes were typically not statisticallysignificantly different between groups (Appendix G). Several outcomes were also parentreported, and parents were often aware of intervention status.
In one low risk of bias RCT, children with autism or Pervasive Development Disorder-Not
Otherwise Specified (PDD-NOS) and a diagnosed sensory processing disorder received SI-based
treatment or treatment focused on building fine motor skills.22 Intervention for both groups
consisted of 18 45-minute sessions over a 6-week span. Both groups improved significantly onblinded parent and teacher ratings of goal attainment (Goal Attainment Scale [GAS]) related tosensory processing, motor skills, and social functioning, with children receiving SI improving
significantly more than those receiving motor skills intervention (p values ≤0.05). Children in the
SI group had significantly fewer parent-rated autistic mannerisms post-treatment than the fine
motor group (p≤0.05), but other measures of sensory processing, ASD symptoms, orneurological functioning did not differ between groups.
Another RCT with moderate risk of bias compared manualized occupational therapy withsensory integration (OT/SI) to care-as-usual.21 OT/SI treatment consisted of three weekly
sessions over the course of 10 weeks, which were monitored for treatment fidelity. Outcome
measurements included parent-generated GAS. After treatment, children receiving OT/SI
showed significantly more goals attained and significantly greater improvements in social skills
and self-care measures compared with children receiving usual care (p=0.003). Scores on theVineland Adaptive Behavior Scales (VABS) or other measures related to functional skills did not
differ between groups. Children receiving OT/SI had greater improvements in need for caregiverassistance with self-care and social skills (p values ≤0.05).
In a retrospective cohort study (high risk of bias) using previously collected data to compare
SI-based therapy in children with high functioning ASD (IQs > 70), both groups received active
treatment that included either SI therapy or eclectic group therapy.39 Treatment lasted for 8 to 10
months. Participants in the SI group improved significantly more than those in the control groupin measures of motor abilities, memory and visualization, and combined sensory motor andcognitive skills conducted by an unblinded investigator (p values<0.05) but not for measures ofspatial positioning and sense of touch or verbal ability. Finally, in a high risk of bias RCT
14evaluating the effects of an SI protocol on low-functioning children with ASD, children
receiving SI intervention had significantly fewer sensory problems at followup than children in
the usual care control group using a parent-rated scale.31

Studies of Environmental Enrichment-Based Approaches
Key Points• Two small RCTs addressing environmental enrichment were short term (<6 months). Neither
study reported harms of intervention.
• Environmental enrichment approaches improved nonverbal cognitive skills. We have low
confidence in this conclusion (low strength of evidence).
• These approaches do not affect expressive language. We have low confidence in thisconclusion (low strength of evidence)• We could not make conclusions about effects on atypical sensory responses or receptive
language as these outcomes were only addressed in one RCT (insufficient strength ofevidence).

Overview of the Literature
Two RCTs (low and moderate risk of bias), both conducted by the same investigators in the
United States, examined environmental enrichment.23, 24 The 78 children included in studies
range in age from 3 to 12 years and received treatment for 6 months, with followup immediately
post-treatment in both studies. Children in the studies had specific diagnoses of autism (vs.
ASD).

Detailed Analysis
Two small RCTs of environmental enrichment examined the same protocol and reported
improvements in ASD symptoms, receptive language, and nonverbal cognitive skills after 6
months of treatment (Appendix G). In one RCT (moderate risk of bias) comparing male children
who received standard care plus sensorimotor enrichment to those who received standard carealone, the treatment group received olfactory/tactile stimulation as well as four to seven otherparent-led, sensory-stimulating exercises twice a day over the course of 6 months.23 Levels ofconcurrent interventions (e.g., speech, behavioral, physical therapies) were similar across groups
and held as stable as possible. Compared with usual care, children receiving environmental
enrichment had a more significant decrease in clinician-rated ASD symptoms (p=0.03) at the endof treatment, with nearly five times as many participants in the treatment group showing
clinically significant drops of five points or more (42% vs. 7%, p=0.03). The treatment groupalso had a 9-point increase in nonverbal cognitive skills as measured by the Leiter-R comparedwith a decrease of approximately 3 points in the usual care group (p=0.008). Both groups
improved on expressive language skills, with no significant differences.
A second RCT (low risk of bias) built upon the preliminary work by examining use of thesame sensorimotor enrichment regimen over 6 months.24 Investigators randomized participants
to three groups: full treatment, as described in the initial study above; partial treatment, which
entailed an abbreviated treatment regimen, and standard care. However, because no differenceswere found between intervention outcomes across the two treatment groups, the study collapsed
findings into a combined treatment group. The treatment groups experienced significant attrition(> 50% across both) that may affect the generalizability of the results. After 6 months, the15treatment group showed more improvement than did the control group in receptive language
skills, but both groups improved comparably for expressive language. The treatment group had
significantly more improvement on mean nonverbal IQ scores as well as parent-rated sensory
reactivity. Although more children in the treatment group compared with the control group
shifted their diagnostic classification on the Autism Diagnostic Observation Schedule-2 (ADOS2) from “autism” to “autism spectrum,” all children across both groups continued to meet the
cut-offs for ASD, making it difficult to interpret the clinical significance of the findings.

Studies of Auditory Integration-Based Approaches
Key Points• All four RCTs addressing auditory integration-based approaches were small and short term(<6 months). No study reported harms of intervention.
• Auditory integration-based approaches do not improve language outcomes. We have low
confidence in this conclusion (low strength of evidence).

Overview of the Literature
Four RCTs with moderate34, 35 and high18 risk of bias evaluated auditory integration-based
approaches. One paper reports two RCTs,18 and two studies were included in our 2011 review.34,
35
Studies included a total of 173 children between the ages of 3 and 13 years, and treatment
duration ranged from 1 week to 18 weeks, with followup immediately post-treatment.

Detailed Analysis
Two small, short term RCTs of auditory integration-based approaches reported no significant
differences between groups in language outcomes assessed on parent, teacher, and clinician
observation measures,34, 35 while two studies reported significant parent-rated improvements inhearing sensitivity and behavior (Appendix G).18
One crossover RCT evaluated the effects of Tomatis Sound Therapy on language skills inchildren with autistic disorder who had not previously had auditory stimulation treatments.34 In
the treatment condition, children listened to music passed through an electronic ear for
attenuation and modulation for two hours per day in accordance with the Tomatis Method
protocol. In the placebo condition, children listened to commercially produced music. The study
reported no significant group effects. Another RCT of auditory integration therapy includingchildren with significant language delays reported no significant benefits of auditory
integration.35
Two high risk of bias RCTs (reported in a single publication18) examined the use of auditory
integration strategies theorized to reduce auditory hypersensitivity by “exercising” the neural
regulation abilities of the middle ear muscles. Across both trials, two different sets of participants
completed five 45-minute sessions on consecutive days. In Trial 1, participants wore headphones
and either listened to filtered music or no sound. In Trial 2, participants either listened to filtered
music or unfiltered music. Participants either had at least five words of functional speech or wereable to follow one-step instructions. It should be noted that although the ADI-R was used toconfirm diagnosis, a subset of participants did not meet full diagnostic cut-offs on this
instrument. One week after intervention, parents reported more improvement in the areas ofhearing sensitivity, spontaneous speech, listening, and behavioral organization after filtered
music compared with children in the control condition (p values <0.01). Children who received
16

filtered music in Trial 2 also had significantly better parent-rated scores on hearing sensitivity
and emotional control compared with control children (p values <0.05). Groups in either trial did
not differ in the other behavioral domains rated.

Studies of Music Therapy-Based Approaches
Key Points• All studies addressing music therapy-based approaches were small and short term (<6months), and none reported harms of intervention.
• We could not make conclusions about effects of music therapy approaches on any outcome
given that studies had multiple comparators and addressed different outcomes (insufficientstrength of evidence).

Overview of the Literature
Four RCTs and one nonrandomized trial (one conducted in Australia,27 one in Iran,38 one in
Brazil,37 one in the United States, 19, 20 and one in Korea30) examined music therapy-based
approaches. One study compared a rhythm-based intervention with a non-human (robot) control
and with human-delivered control intervention.19, 20 One nonrandomized trial comparing music
therapy and toy play was included in our 2011 review.30
Studies included a total of 115 children ranging in age from 3 to 12 years, and treatment
duration ranged from 45 days to 20 weeks. Followup occurred immediately at the end oftreatment in all but one of the studies, which followed up at 2 months post-treatment.38 Twostudies had low risk of bias,19, 20, 37 one had moderate risk of bias,27 and two studies had highrisk.30, 38

Detailed Analysis
The five small studies addressing music therapy reported some significant effects on
measures of behavior (social engagement, behavioral organization), verbal and nonverbal
communication, and joint attention (directing and sharing attention to objects or events) withmusic-based intervention compared with control interventions (Appendix G). Studies useddifferent protocols and addressed different outcomes; thus, drawing conclusions across studies ischallenging. In some studies children also received other interventions in addition to musicbased approaches.
One RCT (low risk of bias) compared Relational Music Therapy to treatment-as-usual in 24
male children with Autistic disorder, PDD-NOS, or Asperger Syndrome.37 Relational Music
Therapy is not a standardized protocol but rather a participant-driven, non-directive approachthat incorporates musical instruments to promote interaction. Intervention consisted of 16 30minute sessions that took approximately 7 months to complete. Groups did not differ
significantly on outcomes measured using the Childhood Autism Rating Scale (CARS) at
followup.
Another low risk of bias RCT compared three intervention conditions (four 45-minutesessions/week for 8 weeks) targeting pre- and post-test measures of communication, attention,and motor skills: a trainer-led rhythm and movement-based group, a robot group focused on
imitation, and a control group engaging in tabletop activities.19, 20 The rhythm and control groups
improved from baseline on an overall measure of joint attention, while the robot group did not;between-group differences were not statistically significant. Both rhythm and robot treatment
17

groups demonstrated greater post-test attention to trainers than to objects than did the control
group (p values <0.001), with greater attention in the rhythm group than the robot group(p<0.001). The rhythm group also demonstrated the greatest duration of spontaneous social
attention, followed by the robot group and the control group (p<0.001). Children in the robot
group also had greater self-directed vocalization compared with the other groups (p values<0.002), while children in the rhythm and control groups had greater spontaneous social
verbalization to trainers than did children in the robot group (p values <0.03).
One RCT (moderate risk of bias) compared family-centered music therapy plus earlyintervention to early intervention only.27 Participants had little to no functional verbal
communication and received 2 to 3 hours of community-based intervention per week while
participating. Intervention consisted of one hour per week of semi-structured sessions within thehome for 16 weeks. Therapists worked with parents and participants to improve selected coresocial engagement skills through music-based activities. Children who received music therapy
had more improvement than controls in parent-rated social engagement (p< 0.001) but remained
significantly impaired relative to typically developing peers. Groups did not differ on parentreported autism symptoms, speech and language, or quality of the parent-child relationship.
In a high risk of bias nonrandomized trial comparing 12 1-hour Orff-Schulwerk music
therapy sessions over the course of 45 days to no treatment, social skills improved significantlyin the treatment group between baseline to post-treatment but not from post-treatment to followup.38 The control group did not improve at any time point, and differences between the treatment
and control groups were not significant at the final followup.
In a final crossover RCT with high risk of bias comparing music therapy and toy play, groups
did not differ on the Pervasive Development Disorder Behavior Inventory (PDDBI), though bothgroups improved with time.30 Results from the Early Social Communication Scales, reflecting
growth in joint attention skills, suggested that music therapy was significantly more effective
than play sessions. Change scores pre- to post- music therapy were significantly greater thanchange scores pre- to post- play sessions. In coding for emotional and motivational
responsiveness (i.e., joy, emotional synchronicity, initiation of engagement), investigators
observed more joy, emotional synchronicity, and initiation of engagement during music therapy
than in play sessions. In addition, children had significantly more compliant behavior andsignificantly fewer episodes of no response behaviors in the music therapy condition.

Studies of Touch/Massage
Key Points••••

One group of investigators conducted five short-term (<6 months treatment duration) studies
comparing massage with no massage treatment, and participant overlap is unclear. No study
reported harms of intervention.
Additional studies assessed massage therapy plus attachment therapy compared with
attachment therapy alone or massage plus SI-based treatment vs. SI-based treatment alone.
Massage improved sensory challenges and ASD symptom severity vs. no massage. Ourconfidence in this conclusion is low (low strength of evidence).
Massage did not improve maladaptive behavior. Our confidence in this conclusion is low(low strength of evidence).

18

•
•

We could not make conclusions about the effects of massage on language/communication
outcomes given inconsistent findings and use of different outcome measures (insufficientstrength of evidence).
We could not make conclusions about longer-term outcomes (≥6 months) as only one study
reported longer-term followup (insufficient strength of evidence). We could not makeconclusions about effects on measures of daily living skills, also assessed in only one study(insufficient strength of evidence). Only one study compared massage plus SI-based
treatment to SI-based treatment alone or attachment therapy plus massage with attachment
therapy alone so we could not make conclusions about these studies (insufficient strength ofevidence).

Overview of the Literature
Seven studies (6 RCTs and one retrospective cohort study) addressed touch-based therapy.
Five studies (four RCTs and one cohort) compared Qigong or traditional massage to no massage
treatment (waitlist condition). 25, 26, 33, 36, 40 One RCT compared massage plus SI-based treatment
with SI-based treatment alone,32 and one retrospective cohort compared attachment therapy plus
massage with attachment therapy alone.41 Studies were conducted in the United States,25, 26, 33, 36,
40
Korea,41and Thailand32 and had moderate25, 33, 36 and high risk of bias.26, 32, 40, 41 Three RCTs
were also reported in our 2011 review.26, 32, 33
One team of investigators has published most of the literature in this area, and the extent ofoverlap among participants in these studies is unclear.25, 26, 33, 40, 42 Studies included
approximately 439 children receiving treatment for 2 to 5 months. One study reported followup
of participants 5 months after the end of treatment.26

Detailed Analysis
Massage Versus No Massage. Almost all of studies are from one group of investigators, and theparticipant overlap is unclear (Appendix F). Some used only parent-and teacher-rated outcomes,
but others used standardized measures of autism symptoms, language, and adaptive functioning(e.g., CARS, Preschool Language Scale [PLS], Vineland Adaptive Behavior Scales [VABS]).
Studies generally reported improvements related to sensory processing, autism symptoms, andparent stress in both treatment and control groups over the course of 5 months of either parent orparent + therapist-delivered intervention, with treatment groups improving significantly morethan controls. Some studies also examined the moderating influence of baseline variables, suchas parent stress or autism severity, which are important confounds to explore. The difficulty
differentiating populations in these studies limits the strength of evidence for their findings,
although results seem promising regarding a sensory-focused intervention that can be delivered
within the home environment with minimal risk of harms.
As noted, four RCTs (three with moderate risk of bias25, 33,36 and one with a high risk ofbias26) and one retrospective cohort study40 (high risk of bias) had unclear participant overlap
and compared children who received Qigong Sensory Training (QST) to wait-listed controls or
usual care. In one study comparing children who received QST to children receiving treatment as
usual,25 parents participated in seven sessions instructing them in the basics of Qigong. Most
children concurrently attended early intervention preschools for 5-10 hours a week, andparticipants included an unknown number of sibling pairs. Children receiving QST significantly
improved from baseline on teacher and parent ratings of autism symptoms as well as parent
19

ratings of sensory challenges, self-regulation skills, communication skills, and maladaptive
behaviors (p values ≤0.05). When compared with the waitlist control group, improvements weresignificantly larger for autism symptoms (PDDBI), parent stress, and sensory/self-regulation
challenges (Sensory and Self-Regulation Checklist), with medium to large effect sizes. Changes
in teacher-rated ASD symptoms (Autism Behavior Checklist [ABC]) were not significantly
different between treatment and control groups. Some children (N not clear) received parent +therapist-delivered massage (dual group) while others received only parent-delivered massage.
While both groups improved on all measures from baseline, children in the dual group had
greater improvements than those in the parent-only group (p values=ns).
Participants in a second RCT included five sibling pairs.26 Children in the treatment groupalso had more severe challenging behaviors and sensory impairments at baseline. Children who
received QST significantly improved on parent- and teacher-reported measures of autism
symptoms, maladaptive behavior, communication skills, and sensory functioning from baseline,
whereas children in the control group improved only on teacher measures of maladaptive
behaviors (p values≤0.05). Children in the treatment group improved significantly more onteacher-rated measures of behavior and language (PDDBI, ABC) but not in maladaptive
behavior compared with the control group. Children who received QST also improved more on
all parent-rated measures of behavior and sensory processing (PDDBI, SSC) than did children in
the control group.26 Parent-rated data on 19 treatment group participants still available for datacollection showed that gains were maintained 5-months after the end of treatment.
A third RCT from the same group compared waitlisted controls to children who received fivemonths of a QST Dual Program (parent + therapist-delivered massage).36 Baseline variables andattrition rates were similar across groups. Children in both groups showed improvement overtime in most domains, although control group improvements were generally of smaller
magnitude than the treatment group. Post-hoc analyses revealed specific treatment effects onparent-reported but not clinician-rated measures: autism symptoms, receptive (but not
expressive) language, sensory processing, and parent stress improved more in the treatmentgroup compared with control (p values <0.01). Group differences in social and living skills were
not significant.
A final study from this group, with high risk of bias and unclear participant overlap withprior studies, retrospectively compared outcomes for children who either received QST for 5months or were waitlisted controls.40 Participants in the treatment groups received two varying
levels of intervention (Home Program—parent only massage; Dual Program—parent + therapistdelivered massage), and outcome measures were reported by both parents and therapists using
different reporting strategies (questionnaire versus observation). Participants in the treatmentgroups showed significant improvements in tactile defensiveness, self-regulation skills, andparent stress levels compared with controls.
Massage + SI-Based Treatment Versus SI-Based Treatment Alone. One RCT with high riskof bias (included in the 2011 review) investigated 8 weeks of SI-based therapy compared with
SI-based therapy plus traditional Thai massage.32 Children in the intervention group (but not thecontrol group) had significantly improved parent ratings of anxiety and conduct both relative tobaseline and relative to controls (p≤0.03). Children in both conditions had improved sleep aswell as teacher ratings of conduct, attention, and activity level, and these ratings did not
significantly differ across treatment groups. Participants in the treatment group had fewer
symptoms of hyperactivity and sleep problems at baseline.32
20

Massage + Attachment Therapy Versus Attachment Therapy Alone. One retrospective
cohort study (high risk of bias) investigated the impact of massage therapy with and without
attachment therapy on social maturity, ASD symptoms, and mother-child attachment.41 The
attachment program involved two hours per day of play activities to promote mother-childinteractions, five days per week, for four months. Participants in the experimental group also
received one hour of massage therapy per week from trained nurses. The nurses encouraged
mothers to talk and sing to children and also demonstrated massage techniques. Social maturity
on the observer-rated Vineland Social Maturity Scale improved in the massage group comparedwith the attachment only group (p=0.005), but CARS scores did not differ significantly between
groups.

Additional Studies
Key Points• One study addressed tactile stimulation exercises and one addressed weighted blankets. Thesestudies provided insufficient data to draw conclusions (insufficient strength of evidence).

Overview of the Literature
One RCT of a tactile input task conducted in the United States had high risk of bias andincluded 34 children between 4 and 14 years old.29 Treatment duration was 24 to 48 hours.
Another RCT with low risk of bias conducted in the United Kingdom included 54 children
between 5 and 16 years of age.28 Treatment duration was 2 weeks. Both studies had followup
immediately post-treatment.

Detailed Analysis
Other interventions with sensory-related components reported few significant differences
between treatment groups (Appendix G).
Tactile Input. One RCT (high risk of bias) examined the impact of a tactile-based task on theability of 34 children with autism to learn a novel task.29 Participants included children who
could not complete standardized cognitive or language evaluations. Children either participatedin a tactual-kinesthetic experience (a “hands on” learning activity) or observed someone else
performing the activity. Stimuli were presented across two sessions, 24-48 hours apart. Children
in the hands-on participation group scored significantly better on ratings of perceived ease of
implementing the learning task than children in the control condition (p values ≤ 0.05).
Weighted Blankets. One crossover RCT with moderate risk of bias examined the impact of aweighted blanket on sleep disturbance in children with severe problems with sleep onset or
maintenance.28 Children used a control or weighted blanket for 12-16 days and then switched.
No significant differences emerged on any of the variables of interest related to sleep
onset/quality, child behavior, or family functioning. Regardless of baseline factors such as
sensory sensitivities, autism severity, and sleep problems, parents were more likely to rate theirchildren as calmer and sleeping better when using the weighted blanket, despite a lack ofphysiological evidence to support this. Additionally, both children and parents reported21

preferring the weighted blanket. Investigators reported that one child developed a rash that may
have been due to the blanket (resolved in 2 days).

Key Question 2. Modifiers of Treatment Outcomes
Few studies were likely adequately powered to assess modifiers of effects, and few studies
reported potential modifiers. While we sought characteristics of interventions, providers, parents,or children that may modify treatment effects, studies reported only child and family
characteristics. We present findings as reported in each study below as potential indicators ofcharacteristics that may affect outcomes.
Child Characteristics. One study of an environmental enrichment-based approach reported thatwhile more children in the treatment group compared with the control group shifted theirdiagnostic classification on the ADOS-2 from “autism” to “autism spectrum,” all children acrossboth groups continued to meet the cut-offs for ASD, making it difficult to interpret the clinicalsignificance of the findings. Baseline language and cognitive skills scores contributed to themajority of the variance when predicting which children in the treatment group would shiftdiagnostic cut-offs on the ADOS.24 In another RCT comparing filtered and unfiltered music,
participants whose parents rated them as having improved hearing sensitivity were more likely toshow an increase in their sharing behaviors during a semi-structured play evaluation.18 An RCT
comparing home-based Qigong massage therapy to waitlisted controls found that children withfewer sensory symptoms and fewer difficulties with self-regulation benefited more from thetreatment program.26 In other studies of massage, treatment effects on child behaviors andlanguage were not moderated by baseline ASD severity as measured on the CARS,36 andinteractions between self-regulation skills and tactile sensitivity or tactile sensitivity andparenting stress were not significant.40
In a music therapy RCT, analyses based on diagnostic subtype indicated that participants
with diagnoses of autism had significant improvement in the CARS domain of nonverbal
communication (p = .008) compared with children in the control group with diagnoses ofautism.37 The study reported no other significant differences based upon either participant
subtype or treatment received. Finally, one study comparing weighted blankets and regularblankets reported that no baseline factors related to autism severity, sleep problems, or sensory
sensitivities modified parents’ ratings of children’s sleep quality.28
Family Characteristics. Although many studies collected parent report of child functioning,
only one asked parents about their own functioning. One study of massage assessed parental
stress levels and found that children in the treatment group had greater improvements in autism
symptoms and overall behavior if their parents were less stressed at intake.25 This would be an
important avenue of future research, given that parental and family variables may influence how
parents perceive children’s functioning and subsequently complete questionnaires. Another study
evaluated the quality of parent-child relationships as a potential modifier but did not find any
treatment effects.27

Key Question 3. Time to Effect of Interventions
No study examined the time to effect for sensory related interventions.

22

Key Question 4. Evidence That Effects Measured at the End
of Treatment Predict Long-Term Functional Outcomes
Only two studies conducted a followup after treatment ended. Followup occurred at two andfive months in each study.26, 38 Additionally, many of the outcome measures were based uponparent reports rather than using standardized interactive assessments. Therefore, little existing
evidence at this time contributes to predicting long-term functional outcomes.

Key Question 5. Effectiveness Across Environments orContexts
We did not identify studies addressing this outcome directly. Many studies collected parent
or teacher report of sensory sensitivities as a way of assessing functioning in multiple
environments, but these assessments generally did not evaluate functioning within multiple
specific contexts.

Key Question 6. Drivers of Treatment Outcomes
We did not identify any studies addressing this KQ.

23

Discussion
State of the Literature
We identified a total of 24 studies (20 randomized controlled trials [RCTs], 1 nonrandomized
trial, 3 retrospective cohort studies) addressing interventions targeting sensory challenges inchildren with autism spectrum disorder (ASD). Three studies had low risk of bias,22, 24, 37 10 had
moderate,19-21, 23, 25, 27, 28, 33-36 and 11 had high risk (including one paper reporting 2 uniquestudies).18, 26, 29-32, 38-41 Most studies were small and used different outcome measures. Treatment
length varied from two days to 10 months, with two studies reporting followup after theimmediate intervention period.26, 38 Protocols involved either parents or therapists engaging in
one-on-one or group interactions; one RCT used a robot-delivered approach.
Compared with our previous review, more studies were designed in ways that increased theirstrengths, including random assignment and tracking of attrition; stratification of assignment ormatching based upon key baseline variables; blinded ratings; treatment fidelity protocols;
tracking or controlling for concurrent interventions; and using standardized outcome measures ormeasures that incorporated parent-selected outcomes of importance such as goal attainment
scaling. We also identified more evidence addressing sensory-integration-based, environmental
enrichment, music therapy, and massage modalities in particular. Although more information isavailable, the lack of consistency in implementation, combined with generally small sample sizes
and limited followup, makes it difficult to draw strong conclusions regarding treatment efficacy.
Similarly, many studies continued to rely upon parent report of symptoms, although others
used unbiased ratings of behavior (such as actigraphy or standardized measures) as well. It will
be important for future work to compare sensory-based interventions not only to treatment as
usual, but to other interventions that involve engaged and active time with an adult, as did somestudies in the current review.22, 24, 41 Additional research is needed that controls forenvironmental or social factors that could cloud our ability to draw conclusions regarding effects.

Summary of Key Findings and Strength of the Evidence
Key Question 1. Benefits and Harms of Interventions Targeting
Sensory Challenges
Sensory Integration (SI)-Based Approaches
In four small, short-term studies, sensory-related outcomes improved in children receiving an
SI-based intervention compared with those receiving usual care or other treatment (significant
improvements in three of four studies addressing the outcome). We have low confidence in thisconclusion (low strength of evidence). Motor skills outcomes were significantly improved inchildren receiving SI-based treatment compared with those receiving usual care or othertreatment (significant improvements in three of three studies addressing the outcome). We have
low confidence in this conclusion (low strength of evidence). Evidence was insufficient to draw
conclusions regarding other comparisons and outcomes. Table 4 outlines these findings.

24

High

Inconsistent

Reporting Bias

Sensory
Challenges

Precision

Risk of Bias andNumber ofStudies (NTotal)

Directness

Study Design

Consistency

Intervention/
OutcomeStudy Limitations

Table 4. Strength of the evidence for sensory integration-based interventions versus control
approaches

DirectImprecise

Undetected

RCT: 1 low,22 1
moderate,21 1
high31(N=99)
Retrospective
Cohort: 1 high39(N=20)

Motor Skills

High

Consistent

DirectImprecise

Undetected

RCT: 1 low,22 1
moderate21(N=69)
Retrospective
cohort: 1 high39(N=20)
N=number; RCT=randomized controlled trial; SOE=strength of the evidence

Finding
Strength of Evidence Grade

Low SOE for positive effects
of sensory integrationbased approaches on
sensory challenges
Significant improvements insensory-related behaviors intreatment groups comparedwith control in 2 RCTs and one
cohort study. No groupdifferences in third RCT onparent-reported measure of
sensory behaviors but
significant improvement intreatment group in sensoryrelated goals; all studies were
small and short-term
Low SOE for positive effects
of sensory integration on
motor skills
Significant improvements intreatment groups vs. control in
3 small studies

Environmental Enrichment-Based Approaches
Two small RCTs of environmental enrichment examined the same protocol involving parentled sensory stimulation exercises and reported improvements in ASD symptoms, receptive
language, and nonverbal cognitive skills after 6 months of treatment.23, 24
We have low confidence in the conclusion that these approaches improved nonverbal
cognitive skills (low strength of evidence). These enrichment approaches do not affectexpressive language. We have low confidence in this conclusion (low strength of evidence). We
could not make conclusions about effects on atypical sensory responses or receptive language asthese outcomes were only addressed in one RCT24 (insufficient strength of evidence). Table 5
outlines these findings.

25

Reporting Bias

Nonverbal
Cognitive Skills

Precision

Risk of Bias andNumber ofStudies (NTotal)

Directness

Study Design

Consistency

Intervention/
OutcomeStudy Limitations

Table 5. Strength of the evidence for environmental enrichment interventions versus usual care

High

Consistent

DirectImprecise

Undetected

RCT: 1 low,24 1
moderate23(N=78)

Expressive
Language

Finding
Strength of Evidence Grade

Low SOE for positive effects
of enrichment on IQ
Significant improvements in IQ(Leiter) in children receiving
enrichment compared with thosereceiving usual care in 2 small
RCTs with short-term followup
and high limitations given small
sample size

High

Consistent

DirectImprecise

Undetected

Low SOE for lack of effect ofenrichment on expressive
language

RCT: 1 low,24 1
moderate23(N=78)

No group differences in
expressive language in 2 small
RCTs with short-term followup
and high limitations given small
sample size
IQ=intelligence quotient; N=number; RCT=randomized controlled trial; SOE=strength of the evidence

Auditory Integration-Based Approaches
Two small, short-term RCTs of auditory integration-based approaches assessing language
outcomes reported no significant differences between groups in receptive language outcomes;34,
35
one RCT (in a publication reporting 2 unique studies) reported significant parent-rated
improvements in spontaneous speech.18 We have low confidence in the conclusion that theseapproaches do not improve language outcomes (low strength of evidence) (Table 6).

26

Reporting Bias

High

Precision

Language

Study Design

DirectImprecise

Undetected

Consistency

Risk of Bias andNumber ofStudies (NTotal)

Study Limitations

Intervention/
OutcomeDirectness

Table 6. Strength of the evidence for auditory integration-based interventions versus control
approaches

Inconsistent

RCT: 2moderate,34, 35 1
high18(N=91)

Finding
Strength of Evidence Grade

Low SOE for lack of effects ofauditory integration
approaches on language
No group differences inoutcomes in 2 small crossover
RCTs with short-term followup;
parent-rated improvements inspontaneous speech intreatment group vs. control in athird RCT

N=number; RCT=randomized controlled trial; SOE=strength of the evidenceMusic Therapy-Based Approaches
Five small studies addressing music therapy reported some significant effects on measures of
behavior (social engagement, behavioral organization), verbal and nonverbal communication,and joint attention with music-based intervention compared with control interventions; however,studies used different protocols and addressed different outcomes
We could not make conclusions about the effects of music therapy approaches on any
outcome given that studies had multiple comparators and addressed different outcomes(insufficient strength of evidence).

Massage-Based Approaches
As noted, five of seven massage studies were from one group of investigators, with unclear
participant overlap.25, 26, 32, 33, 36, 40 These studies generally reported improvements related tosensory processing, autism symptoms, and parent stress in both treatment and control groups
over the course of 5 months of either parent or parent + therapist-delivered intervention, withtreatment groups improving significantly more than controls. The difficulty differentiating
between these works limits the strength of evidence for their findings, although results seempromising regarding a sensory-focused intervention that can be delivered within the homeenvironment with minimal risk of harms. Two additional studies assessed massage therapy plus
attachment therapy compared with attachment therapy alone or massage plus SI-based treatment
vs. SI-based treatment alone.32, 41
Massage improved sensory challenges and ASD symptom severity vs. no massage. Ourconfidence in this conclusion is low (low strength of evidence). Massage did not improvemaladaptive behavior. Our confidence in this conclusion is low (low strength of evidence due tounclear extent of overlap among participants and high study limitations [unblinded ratings,
diagnostic processes]).
We could not make conclusions about the effects of massage on language/communication
outcomes given inconsistent findings and use of different outcome measures (insufficient27

strength of evidence). We could not make conclusions about longer-term outcomes (≥6 months)
as only one study26 reported longer-term followup (insufficient strength of evidence). We could
not make conclusions about effects on measures of daily living skills, also assessed in only one
study36 (insufficient strength of evidence). Only one study compared massage plus SI-based
treatment to SI-based treatment alone32 or attachment therapy plus massage with attachment
therapy alone41 so we could not make conclusions about these studies (insufficient strength ofevidence). Table 7 outlines these findings.

Reporting Bias

ASD Symptom
Severity

Precision

Risk of Bias andNumber ofStudies (NTotal)

Directness

Study Design

Consistency

Intervention/
OutcomeStudy Limitations

Table 7. Strength of the evidence for massage-based interventions versus waitlist control
conditions

High

Consistent

DirectImprecise

Undetected

RCT: 2moderate,25, 36 1
high26(N=191)

Sensory
Challenges

High

Consistent

DirectImprecise

Undetected

RCT: 2moderate,25, 36 1
high26(N=191)

Strength of Evidence Grade

Low SOE for improvements in
ASD symptom severity withmassage vs. control in the
short-term (<6 months)
Significant group differences inall 3 studies; SOE is low given
unclear overlap in participants
and high study limitations
Low SOE for positive effects
on sensory challenges withmassage vs. control in the
short-term (<6 months)
Significant group differences inall 4 studies; SOE is low given
unclear overlap in participants
and high study limitations

Retrospective
Cohort: 1 high40(N=129)Maladaptive
Behaviors

Finding

High

Consistent

DirectImprecise

Undetected

RCT: 1
moderate,25(N=42), 1 high26(N=46)

Low SOE for no effect onmaladaptive behaviors withmassage vs. control in the
short-term (<6 months)
No significant group differencesin 2 studies; SOE is low given
unclear overlap in participants
and high study limitations

N=number; RCT=randomized controlled trial; SOE=strength of the evidence

Additional Interventions
Additional interventions with sensory-related components (tactile stimulation exercises,29
weighted blankets28) reported few significant differences between treatment groups. Thesestudies provided insufficient data to draw conclusions about any outcomes (insufficient strengthof evidence).
28

Other Key Questions
Few studies were likely adequately powered to assess modifiers of effects, and few studies
reported potential modifiers. We did not identify studies addressing the time to effect ofinterventions; evidence that effects measured at the end of treatment predict long-term functional
outcomes; effectiveness of treatments across environments or contexts (e.g., clinic, home,school); and drivers of treatment outcomes.

Findings in Relation to What Is Already Known
We identified eleven recent (2010-present) systematic reviews addressing interventions
targeting sensory challenges.6, 10, 43-51 Three reviews were not specific to children with ASD but
included studies of individuals with developmental disabilities.6, 10, 48 As a number of thesestudies included children with ASD, we retained these reviews.
Reviews addressed comprehensive sensory integration approaches (typically clinic-based
interventions using sensory-enhanced modalities to integrate sensory information and potentiallyameliorate specific challenges or behaviors); “sensory-based” interventions targeting
somatosensory or vestibular symptoms such as therapy balls, massage, and weighted vests;
auditory integration; massage; and music therapy. Our findings generally align with these priorreviews of interventions. Reviews noted low to moderate support for sensory integration-based
approaches and limited evidence for other approaches. Reviews consistently noted considerable
heterogeneity, limited study quality/high risk of bias, limited followup, and lack of treatment
fidelity. Reviews differentiating sensory integration approaches and more general “sensorybased” approaches reported better evidence from those studies that evaluated specific, typicallymanualized sensory integration modalities compared with sensory-based approaches. One review
of auditory integration approaches reported no evidence of effectiveness. One review of music
therapy reported promising findings related to improvements in social interaction andcommunication, and one addressing massage reported that limited evidence precluded
conclusions. We provide more detailed summaries of these reviews below.

Reviews of Sensory Integration or Sensory-Based Approaches
One review evaluating interventions for sensory processing disorders in children with ASD
included 15 single subject design studies, two RCTs, one non-randomized trial, and one casereport addressed sensory integration (n=5 studies) or sensory-based interventions (n=14
studies).3 Six studies had scores of at a least 5 on the 10 point PEDro scale, and four reported
higher level evidence on the Center for Evidence-Based Medicine scale. The review reported
positive effects on children’s individualized goals (effect sizes ranging from 0.72 to 1.17)
associated with sensory integration approaches but noted that durability and generalizability ofeffects was unclear. Evidence for sensory-based approaches was limited, and the review notedthat studies suggest no support for weighted vests and little conclusive evidence for therapy balls
or other multisensory inputs.
Another review addressing Ayres sensory integration (4 studies) and more general sensorybased interventions (18 studies) in children and adults with ASD reported similar results.50The
studies addressing sensory integration included 133 children, and reviewers noted significant
improvements in individualized goals, symptom severity, and sleep in studies with low risk ofbias. Sensory-based studies (including single subject studies and systematic reviews) reported
few positive effects and generally lacked measures of treatment fidelity.
29

In another review including 25 studies addressing sensory integration therapy for children
with ASD, investigators noted positive effects in three studies, mixed findings in eight, and nobenefits in 14.49 The review considered “sensory integration” broadly, and did not differentiate
manualized sensory integration from approaches such as weighted vests or brushing.
Investigators considered 16 studies to report a “suggestive” (vs. conclusive) level of evidence
based on methodologic limitations and concluded that the evidence base does not support use of
sensory integration to treat children with ASD.
One review assessing sensory-based treatment in children with disabilities (including 236 of
856 children with ASD) included 15 comparative studies (including 13 RCTs) and 15 single
subject design studies.6 Investigators noted methodologic flaws in randomization (forcomparative studies) and blinding and fidelity and reported inconsistent results for sensory
integration approaches (no group differences in 3 studies, improvements in sensory behaviors
and goal attainment in the sensory treatment arm in 4, and greater improvements with behavioral
vs. sensory treatment in 2 other studies). Evidence for positive effects of weighted vests waslacking in six studies and mixed results for therapy balls in two studies. Overall the review
concluded that inconclusive evidence supports the efficacy of sensory-based approaches and thatsuch approaches are more likely to be ineffective than effective for the majority of children with
developmental disabilities.
Another review of single subject studies of individuals with disabilities assessed “sensory
integration” broadly and included 17 studies, six including children with ASD.48 The
investigators considered all studies to have high risk of bias and noted a lack of evidence for theefficacy of interventions: few studies reported positive effects, even those studies with better
quality.
A third systematic review also focused on sensory approaches for children with behavioral
problems (not necessarily ASD) and included 14 studies (11 included children with ASD,
n=185).10 Seven studies were single-subject design and four were RCTs. Investigators rated all
studies as excellent or good quality on the PEDro scale and categorized interventions as tactile-,
proprioceptive-, or vestibular-based. The review noted some positive effects associated withtactile approaches, particularly massage, on challenging behaviors including inattention.
Proprioceptive studies—all single subject—evaluated weighted vests and reported mixed
findings related to on-task, self-stimulatory, and stereotypic behaviors (improved findings in one
study, mixed in two, and no effects in another). Vestibular-based approaches included therapy
balls/cushions and horseback riding. Investigators noted limited positive effects on engagement
in classroom activities associated with therapy balls. The review concluded that evidence for
effectiveness of sensory-based interventions remains unclear.
Two other reviews focused broadly on interventions to improve social participation, play,adaptive behavior, education, and repetitive behavior included few studies addressing sensory
challenges (n=3) and noted insufficient evidence for effects on social communication47 andpositive effects on self-care in one RCT.46

Other Reviews
Auditory Integration. One Cochrane review of auditory integration approaches for people with
ASD included six RCTs with moderate to high risk of bias.44 The review reported some
improvements in language and challenging behaviors in small studies with disparate outcome

30

measures and limited followup but concluded that interventions overall were ineffective forindividuals with ASD.
Music Therapy. Another Cochrane review of 10 studies (n=165 children with ASD), including
materials such as theses and study designs including single subject studies, assessed music
therapy and reported significant improvements in social interaction within and outside thetherapy context and in communication and social reciprocity in the therapy context.52 Nonverbal
communication in non-therapy contexts was not significantly improved. The review concluded
that music therapy may improve social interaction, communication, social reciprocity skills inchildren with ASD. These results differ from those reported in the current review, likely because
we included only comparative studies of music therapy with at least 10 participants.
Massage. One review of massage therapy for children with ASD included six comparative
studies and reported some positive effects of massage on symptom severity, communication, andsensory outcomes; however, investigators considered all trials to have high risk of bias.43 The
review concluded the evidence for massage as an ASD treatment is limited and methodologic
limitations do not allow firm conclusions.

ApplicabilityChildren in studies meeting our review criteria are similar to the general population ofchildren with ASD and associated sensory challenges in that they represent the heterogeneity of
impairments and behavioral challenges associated with ASD. Some studies included children
with limited functional speech31, 34 and/or intellectual disability.35, others included children withhigher cognitive abilities and milder ASD symptom profiles.22, 39 Differences in severity of
expression of ASD or in comorbid conditions may limit applicability of findings to children withlevels of symptom expression.
Interventions typically used differing approaches incorporating sensory-focused strategies;
thus, findings reported here may not be replicated with interventions using different
combinations of strategies or targeting different aspects of sensory functioning. Many of theinterventions required expertise in specific sensory-related strategies that likely limit theirgeneralizability to community settings; some lacked manualization, and as a consequence likely
have limited replicability/community extension. Others were specifically designed to be
conducted by parents, under the supervision of a trainer.
In terms of comparison or control interventions, virtually all “control” participants in the
included studies were receiving some level of treatment, aside from participants in one RCT.38
Some studies attempted to document additional interventions through parent report todemonstrate that baseline rates were comparable across groups, whereas others required that no
new interventions be added during the study duration. Outcomes may differ among children
receiving different concomitant therapies.
Outcomes also varied across studies, but most studies incorporated commonly used measuresof autism symptom severity, behavior, language, and sensory difficulties. Many of these werebased upon parent report, although an increasing number used standardized interactive or
observational measurement strategies. Some studies also incorporated outcomes of key
importance to parents/caregivers that simultaneously attempted to balance assessing
comparability between treatment groups with the heterogeneity inherent in ASD.21, 22 Use ofvalidated, standardized measures improves potential generalizability of findings by helping to31

establish a shared understanding of progress and to compare outcomes across different
intervention modalities and studies. Standardized measures supplemented with moreindividualized assessment strategies can also help to improve sensitivity by measuring smaller
effects and incorporating elements of children’s individual family or treatment context.
Treatment duration ranged from a week to 10 months, and most studies reported outcomes
immediately following the end of treatment, making durability of effects difficult to assess. Few
studies attempted to assess characteristics of the child, family, provider, or intervention approachthat may affect outcomes, or whether outcomes extended to other settings and environments.
However, the use of control groups, treatment fidelity checks, and replicable and manualizedintervention protocols establishes a promising baseline for future investigations.
Given the heterogeneity of these studies, and the heterogeneity of children with ASD, theextent of generalizability to the overall population of children with ASD and sensory challenges
is limited and difficult to assess.

Implications for Clinical and Policy Decisionmaking
This review provides limited evidence for decisionmaking about interventions targeting
sensory challenges. The small body of comparative literature provides some evidence to support
sensory integration-based and touch/massage-based interventions for some children; bothinterventions positively affected sensory challenges and motor skills. Studies were typically shortterm and included few children, however, so our confidence in these effects is low.
Decisional dilemmas remain regarding characteristics of the child, family, or intervention
that may modify effectiveness or predict which children may be most likely to benefit from agiven approach. Similarly, the literature base is currently insufficient to inform ourunderstanding of the time to effect of interventions, longer-term effectiveness of interventions,generalizability of effects outside the treatment context, and components that may drive
effectiveness. Though not explicitly assessed in the studies reported here, harms associated withthese approaches are likely minimal and caregivers and clinicians must balance the need toameliorate sensory challenges with the costs of time, effort, and costs and demands of otherinterventions that a child may receive. As such, caregivers and referring providers should assess
the possible benefits of specific sensory-focused intervention modalities based upon theindividual needs of the child, broader family goals and capacities, and interventions of moreestablished effectiveness. In this capacity, some practice groups have recommended clear
communication regarding the limits of intervention.53, 54

Limitations of the Comparative Effectiveness Review
Process
We included studies published in English only and did not include unpublished data or datain theses or conference proceedings. We scanned a random sample of 150 non-English abstracts
retrieved by our MEDLINE search. Most studies appeared to be case series, narrative reviews,
basic science studies, or studies assessing etiology. Only two studies appeared to meet inclusion
criteria; thus, given the high percentage of ineligible items in this scan (99%), we concluded that
excluding non-English studies would not introduce significant bias into the review. We
recognize that this preliminary scan did not address the entire corpus of ASD literature publishedin other languages.

32

We also included only comparative studies of interventions with a sensory-specific focus andincluding at least 10 children with ASD. This undoubtedly means that most single-subject design
studies are not included in this review. Single-subject designs can be helpful in assessing
response to treatment in very short timeframes and under very tightly controlled circumstances,
but they typically do not provide information on longer-term or functional outcomes. Suchstudies are useful in demonstrating effects, yielding initial evidence that an intervention merits
further study or in identifying whether a particular approach to treatment is likely to be helpful
for a specific child. Our goal was to identify and review the best evidence for assessing theeffectiveness of interventions targeting sensory challenges in children with ASD, with an eye
toward utility in the larger population of children with ASD. By definition, “populations” insingle-subject design studies are likely to be idiosyncratic and therefore unlikely to provide
information that is generalizable. We also included summaries of other recent reviews to attempt
to mitigate any loss of information associated with this criterion.
We also note that other approaches to categorizing sensory-focused interventions could be
used and that consensus on a categorization approach is lacking. We chose to group studies
based on the core strategies used in each intervention. In some cases this approach functionallygrouped interventions that may have used specific, manualized techniques with others that used
only a subset of those techniques (e.g., Ayres-based sensory integration and sensory integration
models that may have used some Ayres strategies). As noted, no alternative analytic approaches(e.g., considering Ayres-based approaches and other sensory integration approaches as separate
categories) would have changed our overall strength of evidence assessment.
This review was also focused specifically on children with ASD and specifically oninterventions targeting sensory challenges. Sensory approaches may be used with individuals
with other impairments, and findings may be generalizable to children with ASD; however,including studies in children with other conditions was beyond the scope of the current review.
We also recognize that interventions with a primarily educational or behavioral focus may
also address sensory-related outcomes, but inclusion of any intervention approach reporting asensory-related outcome was outside the scope of the current review. Similarly, we focused onchild-related outcomes and did not address measures of parent stress, despite the key importanceof the outcome and family context. Finally, we used a non-validated tool to assess risk of bias,
though we note that the tool evaluates similar constructs to those assessed in tools such as thatused by the Cochrane Collaboration, with the addition of ASD-specific domains.

Limitations of the Evidence BaseAs noted, studies in the review had small sample sizes (median 34 total) and typically limited
duration of intervention and followup after intervention. Populations across studies were
heterogeneous in terms of sensory challenges, ASD severity, age, and intellectual and adaptivefunctioning. Roughly half of studies (12 of 23) did not control for concomitant interventions orreport assessment of treatment fidelity. Few used an appropriate statistical analysis (e.g.,correction for multiple testing). Ten of 23 studies did not use blinded outcome assessors.
Interventions, even within our broader categories, used differing sensory-specific approaches
in differing combinations of components, settings, and duration. Longer-term outcomes arelimited as is our ability to determine effects of intervention on the underlying sensory challenges
themselves. Potential harms of interventions were addressed in only one study, and few studies
assessed potential factors that may modify effectiveness or drive effects of interventions. Studies

33

often used multicomponent strategies, and teasing apart effects of specific components is not
currently possible.
Despite these limitations, investigators have made significant improvements in incorporating
commonly used measures of symptom severity, behavior, language, and sensory difficulties tofacilitate comparisons across studies. Parent-reported outcomes are necessary in this populationof children, many of whom may not be able to complete aspects of assessments; however,studies are increasingly incorporating standardized interactive or observational measurement
strategies. As noted above, the increasing use of treatment fidelity measures and replicableintervention protocols establishes a promising baseline for future investigations. Investigators in
the area are also well-aware of the challenges of conducting research using a disparate andvariously defined set of approaches in a highly heterogeneous population and have made strides
in incorporating outcome measures that attempt to balance heterogeneity and comparative
effectiveness and measures of intervention fidelity.15

Research Gaps and Areas for Future Research
Improving research in this area should also include considerations of power and sample size.
Sample size was frequently insufficient to allow firm conclusions. In addition, researchers should
continue to provide adequate detail as they describe their populations and interventions to allow
for replicable research. Ideally, investigators publish the treatment manuals they develop, which
are then referenced in later research; despite gains in this area, many studies made generalreferences to their use of an underlying approach without specifying the ways in which they usedor modified the technique. Lack of detail about the intervention makes it difficult to assess theapplicability of individual studies, to synthesize groups of studies, or to replicate studies.
Duration of treatment and followup were generally short, and the extent to which effects oftherapies could be expected to continue after cessation of treatment is not clear.
While some approaches may not hypothesize such durability (i.e., approaches designed forongoing use with improvements associated with continued treatment), such data are ultimately
necessary for guiding pragmatic implementation and setting realistic expectations of effects forclinicians and families.
In addition, few studies adequately accounted for concomitant interventions that might
confound observed effectiveness. Accounting for concomitant interventions should bestandardized in future research.
As noted, more studies used a common set of outcome measures, but the extent to whichthese measures assess changes in potential underlying sensory-related impairments is not clear,and understanding whether intervention can alter potential impairments in sensory processing(vs. altering behavioral responses in the short term) is a critical need. Translational work tounderstand the relationship between sensory symptoms and their potential neurobiology would
inform intervention design.
Another critical area for further research is identifying which children are likely to benefit
from particular interventions. To date, studies have provided limited characterization of the
subpopulation of children who experience positive response to intervention and limited
characterization of the extent or type of sensory challenges children experience at baseline.
Interventions targeting sensory challenges by their nature often employ multiple components,
and data on whether specific functional components of the interventions drive effectiveness are
currently unavailable. Component analyses in this field would be productive for refining
intervention approaches and for assessing applicability and generalizability of the results.
34

In line with this need, we recommend future consideration of the ways in which the culturalcontext of the child and family may affect the applicability or effectiveness of specificinterventions. The setting of interventions may also influence effects, and understanding the roleof context broadly in contributing to effects is an important need. As noted, understanding theextent to which findings from studies of these interventions in children with other conditions areapplicable to children with ASD may help to bolster the evidence base.

Conclusions
Some interventions targeting sensory challenges may lead to modest improvements primarily
in sensory- and ASD symptom severity-related outcomes; however, the evidence base for any
category of intervention is small, and durability of effects beyond the immediate intervention
period is unclear. Sensory integration-based approaches improved outcomes related to sensory
challenges and motor skills, and studies of massage reported improvements in sensory responses
and ASD symptoms. Environmental enrichment was also associated with improvements innonverbal cognitive skills in the short-term. Auditory integration-based approaches did not
improve language outcomes. Some positive effects were associated with other approaches
studied (music therapy, weighted blankets) but findings in these small studies were notconsistent. Data on longer-term results are lacking, as are data on characteristics that modify
outcomes, generalizability of findings, and components of interventions that may drive effects.
In sum, while some therapies may hold promise and warrant further study, substantial needs exist
for continuing improvements in methodologic rigor in the field.

35

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Acronyms and Abbreviations
ABC
ADOS
AHRQ
ASD
CARS
CER
DSM
G
GAS
IQ
KQ
n
NR
NS
OT/SI
PDDBI
PDD-NOSPICOTS
PLS
QST
RCT
SI
SOE
SSC
TEP
VABS

Autism Behavior Checklist
Autism Diagnostic Observation Schedule
Agency for Healthcare Research And Quality
Autism Spectrum DisorderChildhood Autism Rating Scale
Comparative Effectiveness Review
Diagnostic and Statistical Manual
Group
Goal Attainment SettingIntelligence Quotient
Key Question
NumberNot Reported
Not Significant
Occupational Therapy with Sensory Integration
Pervasive Development Disorder Behavior Inventory
Pervasive Developmental Disorder – Not Otherwise Specified
Population, Intervention, Comparator, Outcome, Timing, Setting
Preschool Language Scale
Qigong Sensory Training
Randomized Controlled Trial
Sensory Integration
Strength of Evidence
Sense And Self-Regulation Checklist
Technical Expert Panel
Vineland Adaptive Behavior Scales

40Appendix A. Detailed Methods
Topic Surveillance and Review Protocol
These procedures follow the methods outlined in the Agency for Healthcare Research andQuality (AHRQ) Effective Health Care Program Methods Guide for Effectiveness andComparative Effectiveness Reviews.1 The topic for the original report2 was nominated by Autism
Speaks in a public process using the Effective Health Care website. AHRQ published an update
addressing behavioral interventions in 2014.3 We conducted a surveillance process to assess theneed to update the report by contacting topic experts about the relevance of the Key Questions(KQs) and new evidence that may address them. All members of the research team were required
to submit information about potential conflicts of interest before initiation of the work. No
members of the review team had any conflicts.
In consultation with clinical experts and stakeholders, and based on our preliminary scan of
the literature and surveillance findings, we focused the review update on approaches to address
sensory challenges and medical approaches (reported in a separate update). These areas reflect
both areas of clinical relevance and sufficient newly published literature for a review update.
Given the different foci of these interventions (i.e., sensory challenges and challenging
behaviors) and subsequent differences in study populations, we report findings in two separate
reviews.
Based also on the surveillance process and discussions with stakeholders, we revised the KQ
addressed in the 2011 report to reflect the focus on medical and sensory approaches specifically.
We also eliminated a question on approaches for children at risk for ASD as such children areunlikely to be included in studies in the target areas for this review update.
After review from AHRQ, the questions and framework were posted online for publiccomment. No changes to the questions or framework were recommended. We identified
technical experts on the topic to provide assistance during the project. The Technical Expert
Panel (TEP), representing the fields of pediatrics and developmental pediatrics, psychiatry,family medicine, and occupational therapy and allied health, contributed to the AHRQ’s broader
goals of (1) creating and maintaining science partnerships as well as public-private partnerships
and (2) meeting the needs of an array of potential users of its products. Thus, the TEP was bothan additional resource and a sounding board during the project. The TEP included sevenmembers serving as technical or clinical experts. To ensure robust, scientifically relevant work,
TEP members participated in conference calls to:• Help to refine the analytic framework and KQ at the beginning of the project;• Discuss inclusion/exclusion criteria; and• Assist with determining key interventions and outcomes of interest.
The final protocol was posted to the AHRQ Effective Health Care web site and registered in
the PROSPERO international register of systematic reviews (ID#: CRD42016033941).

Literature Search Strategy
Search Strategy
To ensure comprehensive retrieval of relevant studies of therapies for children with ASD, weused four key databases: the MEDLINE® medical literature database via the PubMed® interface;
EMBASE (Excerpta Medica Database), an international biomedical and pharmacologicalA-1

literature database via the Ovid® interface; the Cumulative Index of Nursing and Allied Health
Literature (CINAHL), and PsycINFO®. Search strategies for KQs applied a combination ofcontrolled vocabulary (Medical Subject Headings [MeSH] and Emtree headings) to focus
specifically on interventions targeting sensory challenges in children with ASD and harms ofinterventions (Appendix B). We restricted literature searches for KQs to studies published from2010 to September 2016 to reflect literature available since the publication of the 2011 review.
We will update searches while the report is undergoing peer review.

Gray Literature
We searched web sites of organizations likely to conduct research, issue guidance, or
generate policies for ASD (e.g., Autism Speaks, the American Academy of Child and Adolescent
Psychiatry) to inform the review’s background and discussion sections. We searched governmentand regulatory agency web sites for contextual information on benefits and harms of ASD
interventions. We searched ClinicalTrials.gov and other trial registries for information about
relevant ongoing trials and to confirm that we have obtained available publications of resultsfrom completed trials.

Inclusion and Exclusion Criteria
Table A-1 outlines inclusion criteria. We required that eligible RCTs have a total minimum
sample size of 10. We required a higher minimum sample size (n=20) for other comparative
studies as they typically have fewer controls for bias than RCTs. We recognize that these study
design criteria excluded single-subject or single-case experimental designs that have been used to
study interventions targeting sensory challenges. These studies are challenging to incorporate ina meaningful way in comparative effectiveness reviews, which attempt to evaluate theeffectiveness of interventions at the population level. To mitigate the exclusion of such studies;
however, we include summaries of recent reviews that have included such studies and discuss
our findings in light of those in other reviews (see Findings in Relation to What is Known).
We included studies published in English only. In the opinion of our content experts, muchof the relevant literature on ASD is published in English; however, we scanned a sample of 150
non-English abstracts to gauge the number of anticipated non-English studies that would meetinclusion criteria. Two non-English studies appeared to meet our criteria. Given this small
proportion of potentially eligible studies, we feel that excluding these publications is unlikely tointroduce significant bias.
Eligible studies also reported one or more outcomes of interest and included children at least
2 years of age and up to and including age 12. Studies also included only children with adiagnosis of ASD (or data reported separately for children with ASD).
Table A-1. Inclusion criteria
Category

Criteria

Study Population

Children ages 2-12 with ASD (mean age plus standard deviation is ≤ 12 years and 11
months)Publication Languages

English only

Admissible Evidence(study design and othercriteria)

Admissible designs
Randomized controlled trials, prospective and retrospective cohort studies withcomparison groups, and nonrandomized controlled trials
Other criteria
Original research studies published from 2010—present and not addressed in prior

A-2

Category

Criteria
reviews
Studies must have relevant population and ≥20 participants with ASD (non-RCTs) or atleast 10 total participants (RCTs)

Studies must address one or more of the following for ASD:
-Outcomes of interest-Treatment modality of interest-Predictors or drivers of treatment outcomes (e.g., biomarkers, clinical changes)-Maintenance of outcomes across environments or contexts-Sufficiently detailed methods and results to enable data extraction-Reporting of outcome data by target population or intervention
ASD = Autism Spectrum Disorder; RCT = randomized controlled trial

Study Selection
Once we identified articles through the electronic database searches and hand-searching, we
examined abstracts of articles to determine whether studies met our criteria. Two reviewers
separately evaluated the abstracts of studies identified in our searches for Key Questions forinclusion or exclusion, using an Abstract Review Form (Appendix C). If one reviewer concluded
that the article could be eligible for the review based on the abstract, we retained it. Following
abstract review, two reviewers independently assessed the full text of each included study using
a standardized form (Appendix C) that included questions stemming from our inclusion andexclusion criteria. A senior reviewer resolved disagreements between reviewers.
We conducted all abstract and full text reviews using the DistillerSR online screening
application (Evidence Partners Incorporated, Ottawa, Ontario). Appendix D includes a list of
excluded studies and the reasons for exclusion. Data extracted for each study are available via
the Systematic Review Data Repository (http://srdr.ahrq.gov/).

Data Extraction
The staff members and clinical experts (including two psychiatrists, two psychologists, andthree epidemiologists/systematic reviewers) who conducted this review jointly developed thedata extraction forms for the KQs. We designed forms to provide sufficient information to enable
readers to understand the studies and to determine their quality; we gave particular emphasis toessential information related to the KQs.
The team was trained to extract data by extracting several articles into the template and thenreconvening as a group to discuss the utility of the template. We repeated this process throughseveral iterations until we decided that the templates included the appropriate categories forgathering the information contained in the articles and for potential meta-analyses. Team data
extractors shared the task of initially entering information into the evidence tables. A second
team member also reviewed the articles and edited all initial entries for accuracy, completeness,and consistency. A senior reviewer reconciled disagreements concerning the information
reported.
The full research team met regularly during the article extraction period and discussed issues
related to the data extraction process. In addition to outcomes related to the effectiveness oftreatment (e.g., changes in ASD severity), we extracted all data available on harms. Harms
encompass the full range of specific negative effects, including the narrower definition ofadverse events.
A-3

Data Synthesis
Studies were too heterogeneous to allow for meta-analyses. We summarized data for Key
Questions qualitatively using summary tables.

Risk of Bias Assessment of Individual Studies
We evaluated the overall methodologic risk of bias of individual studies using the ASDspecific assessment approach developed and used in our prior reviews of interventions for ASD
and informed by the Methods Guide for Effectiveness and Comparative Effectiveness Reviews.1
This risk of bias approach considers factors related to study design, diagnostic approach,participant ascertainment, intervention characteristics, outcomes measurement, and statistical
approach and includes questions such as: Did the authors report differences in or hold steady all
concomitant interventions? Were outcomes coded and assessed by individuals blinded to theintervention status of the participants? For randomized controlled trials, was there an intent-totreat analysis? Two senior investigators assessed each included study independently withdisagreements resolved through discussion. Appendix C includes our risk of bias assessment
form, and Appendix E includes the risk of bias ratings for each study.

Determining Overall Risk of Bias Ratings
We used the thresholds we establish in prior reviews to assess overall high, medium or low
risk of bias. We assessed the risk of bias based upon the study-defined primary outcome(s). We
assessed each domain described above individually and considered the individual ratings todetermine an overall quality assessment of low, moderate, or high risk of bias. We required thatstudies receive positive scores on questions related to randomization and diagnostic approach to
be considered low risk of bias. Scores were calculated first by domain and then summed andweighted as described in Table A-2 to determine overall study risk. Studies could receive up to
two points on the domains of study design, diagnostic approach, participant ascertainment, andintervention, and up to one point on the domains of outcome measurement and statistical analysis(10 total points).
Table A-2. Quality scoring algorithm
Definition and Scoring Algorithm

Rating•≥8/10 points, including a ++ on study design and ++ on diagnostic
approach

Low risk of bias••

≥6/10 points, including at least a + on intervention

Moderate risk of bias

≤5/10 points

High risk of bias

Strength of the Body of Evidence
The assessment of the literature is done by considering both the observed effectiveness ofinterventions and the confidence that we have in the stability of those effects in the face of future
research. The degree of confidence that the observed effect of an intervention is unlikely tochange is presented as strength of evidence, and it can be regarded as insufficient, low, moderate,or high. Strength of evidence describes the adequacy of the current research, both in terms ofquantity and quality, as well as the degree to which the entire body of current research provides aA-4

consistent and precise estimate of effect. Interventions that have demonstrated benefit in a small
number of studies but have not yet been replicated using the most rigorous study designs will
therefore have insufficient or low strength of evidence to describe the body of research. Future
research may find that the intervention is either effective or ineffective. Strength of the evidence
is assessed for a limited set of critical outcomes, typically those related to effectiveness of anintervention.
Methods for applying strength of evidence assessments are established in the Methods Guide
for Effectiveness and Comparative Effectiveness Reviews1 and are based on consideration of fivedomains (Table A-3): study limitations, consistency in direction of the effect, directness inmeasuring intended outcomes, precision of effect, and reporting bias. Strength of evidence isassessed separately for major intervention-outcome pairs and incorporates data from the entire
body of reviewed evidence on behavioral interventions (i.e., comparative studies—both RCTs
and prospective and retrospective cohort studies—reported in the 2011 review2 and studies
reported in the current review). We required at least one low risk of bias study for moderate
strength of evidence and two low risk studies for high strength of evidence. In addition, to beconsidered “moderate” or higher, intervention-outcome pairs needed a positive response on two
out of the three domains other than study limitations.
Once we had established the maximum strength of evidence possible based upon thesecriteria, we assessed the number of studies and range of study designs for a given interventionoutcome pair, and downgraded the rating when the cumulative evidence was not sufficient tojustify the higher rating. The possible grades were:• High: High confidence that the evidence reflects the true effect. Further research isunlikely to change estimates• Moderate: Moderate confidence that the evidence reflects the true effect. Further research
may change our confidence in the estimate of effect and may change the estimate• Low: Low confidence that the evidence reflects the true effect. Further research is likely tochange confidence in the estimate of effect and is also likely to change the estimate• Insufficient: Evidence is either unavailable or does not permit a conclusion.
a

Table A-3. Domains used to assess strength of evidence
DomainStudy
Limitations
Consistency

Directness

Precision

Explanation
Degree to which included studies for a given outcome have a high likelihood of adequate protection
against bias (i.e., good internal validity), assessed through study design and study conduct.
Degree to which included studies find either the same direction or similar magnitude of effect.
Assessed through two main elements:•
Direction of effect: Effect sizes have the same sign (that is, are on the same side of noeffect or a minimally important difference).
•
Magnitude of effect: The range of effect sizes is similar.
Extent to which evidence links interventions directly to a health outcome of specific importance forthe review, and for comparative studies, whether the comparisons are based on head-to-headstudies. Evidence may be indirect in several situations such as:•
Outcome being graded is considered intermediate in a review that is focused on clinicalhealth outcomes (such as morbidity, mortality).
•
Data do not come from head-to-head comparisons but rather from two or more bodies ofevidence to compare.
•
Data are available only for proxy respondents instead of directly from patients for situations
in which patients are capable of self-reporting and self-report is more reliable.
Degree of certainty surrounding an effect estimate with respect to a given outcome, based on thesufficiency of sample size and number of events. A body of evidence will generally be imprecise if
the optimal information size (OIS) is not met. OIS refers to the minimum number of patients (andevents when assessing dichotomous outcomes) needed for an evidence base to be consideredA-5

adequately powered.
Reporting
Degree of selective publishing or reporting of research findings based on the favorability of directionBiasor magnitude of effect.
a
Excerpted from Berkman et al. 20134

Applicability
We assessed the applicability of findings reported in the included literature addressing our
KQs to the general population of children with ASD by determining the population, intervention,comparator, and setting in each study and developing an overview of these elements for eachintervention category. We anticipated that areas in which applicability would be especially
important to describe would include ASD severity, comorbidities, age at treatment, andintervention characteristics such provider, dosing/intensity, and setting. Applicability tables foreach KQ are in Appendix F.

Peer Review and Public Commentary
Researchers and clinicians with expertise in treating children with ASD and individuals
representing stakeholder and user communities provided external peer review of this report. The
draft report was posted on the AHRQ Web site for 4 weeks to elicit public comment. We
addressed all reviewer comments, revised the text as appropriate, and documented changes andrevisions to the report in a disposition of comments report that will be made available 3 months
after AHRQ posts the final review on the AHRQ Web site.

A-6

References1.

Methods Guide for Effectiveness and Comparative Effectiveness Reviews. AHRQ Publication No. 10(14)EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality. January 2014. Chapters
available at: www.effectivehealthcare.ahrq.gov

2.

Warren Z, Veenstra-VanderWeele J, Stone W, Bruzek JL, Nahmias AS, Foss-Feig JH, Jerome RN,
Krishnaswami S, Sathe NA, Glasser AM, Surawicz T, McPheeters ML. Therapies for Children With
Autism Spectrum Disorders. Comparative Effectiveness Review No. 26. (Prepared by the Vanderbilt
Evidence-based Practice Center under Contract No. 290-2007-10065-I.) AHRQ Publication No. 11EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality. April 2011. Available at:www.effectivehealthcare.ahrq.gov/reports/final.cfm.

3.

Weitlauf AS, McPheeters ML, Peters B, Sathe N, Travis R, Aiello R, Williamson E, VeenstraVanderWeele J, Krishnaswami S, Jerome R, Warren Z. Therapies for Children With Autism Spectrum
Disorder: Behavioral Interventions Update. Comparative Effectiveness Review No. 137. (Prepared by the
Vanderbilt Evidence-based Practice Center under Contract No. 290-2012-00009-I.) AHRQ Publication No.
14-EHC036-EF. Rockville, MD: Agency for Healthcare Research and Quality; August 2014.
www.effectivehealthcare.ahrq.gov/reports/final.cfm.

4.

Berkman ND, Lohr KN, Ansari M, McDonagh M, Balk E, Whitlock E, Reston J, Bass E, Butler M,
Gartlehner G, Hartling L, Kane R, McPheeters M, Morgan L, Morton SC, Viswanathan M, Sista P, Chang
S. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective
Health Care Program of the Agency for Healthcare Research and Quality : An Update. Methods Guide forComparative Effectiveness Reviews (Prepared by the RTI -UNC Evidence-based Practice Center underContract No. 290-2007-10056-I).AHRQ Publication No. 13 (4)-EHC130-EF. Rockville, MD: Agency for
Healthcare Research and Quality. November 2013. Available at:www.effectivehealthcare.ahrq.gov/reports/final.cfm

A-7

Appendix B. Search Strategies
Table B-1.Treatment/intervention
Interface: PubMed; Database: Medline
SearchRecords

1"Child Development Disorders, Pervasive"[Mesh]

22690

2

(autistic[tiab] OR autism[tiab] OR asperger[tiab] OR asperger's[tiab] OR aspergers[tiab] ORpervasive development[tiab] OR pervasive developmental[tiab] OR pdd[tiab]) NOT medline[sb]

5613

3

#1 OR #2

28303

4

therapy[sh] OR therapeutics[mh] OR psychotherapy[mh] OR treatment outcome[mh]72717565(treatment[tiab] OR therapy[tiab] OR intervention[tiab] OR “control group”[tiab] OR randomized[tiab]
OR outcome[tiab] OR randomized[tiab] OR efficacy[tiab] OR effectiveness[tiab] ORcomparison[tiab] OR compared[tiab] OR trial[tiab] OR “pilot study”[tiab] ) NOT medline[sb]7944596#4 OR #5

80587417#3 AND #6

9859

8(newspaper article[pt] OR comment[pt] OR case reports[pt] OR review[pt] OR practice guideline[pt]OR news[pt] OR editorial[pt] OR historical article[pt] OR meta-analysis[pt] OR legal cases[pt] ORpublished erratum[pt] OR congresses[pt])9#7 NOT #8

6801

10

#9 limited to ("2010/01/01"[Date - Publication] : "3000"[Date - Publication])

3894

5128288

Key: [mh] Medical Subject Heading; [tiab] title/abstract word; [pt] publication type; [sh] subheading; [dp] publication date; [la]language; [pt] publication type.

Table B-2. Sensory integration search in CINAHLInterface: EBSCO host; Database: CINAHL
SearchRecords

1(MH "Autistic Disorder")10,856

2(MH "Child Development Disorders") OR (MH "Child Development Disorders, Pervasive")

2,067

3

"autism"

8,856

4#2 AND #3

511

5#1 OR #4

11,134

6(MH "Sensory Motor Integration") OR (MH "Psychomotor Performance+") OR (MH "Motor Skills+")

15,630

7(MH "Occupational Therapy") OR (MH "Pediatric Occupational Therapy")

15,2788sensory

12,6709#7 AND #8512

10#6 OR #9

15,85311#5 AND #10

461

12

#11 limited to 2010-2015

263

13

#12 limited to English language

262

Table B-3. Sensory integration search in PsycInfo
Database: PsycInfo
SearchRecords

SU.EXACT.EXPLODE("Sensory Integration") AND SU.EXACT.EXPLODE("Autism") Limited to 20102015

B-1

39

Appendix C. Screening and Quality Assessment
Forms
Medical and Sensory-Related Therapies for Children with Autism Spectrum
Disorder Abstract Review Form
1. Addresses intervention approach and outcomes for young children (2-12 years) withASD.
□ Yes □ No □ Cannot Determine
2. Original research (does not include systematic reviews and meta-analyses)□ Yes □ No □ Cannot Determine
3. Is this a comparative study (includes a treatment and comparison group)?
□ Yes □ No □ Cannot Determine
4. Addresses one of the following:□ Behavioral intervention involving training parents□ Sensory or auditory-focused intervention (e.g., sensory or auditory integration, weighted vest,
therapeutic swinging, snoezelen room)□ Medical/pharmacologic intervention, including vitamins/supplements, hyperbaric oxygen,electroconvulsive therapy, transcranial magnetic stimulation□ Music therapy□ Educational intervention□ Complementary and alternative medicine (acupuncture, massage, etc.)□ Allied health intervention (non-sensory/auditory-related such as language, exercise, animalassisted)□ Other behavioral intervention (e.g., social skills, CBT, early intensive intervention)□ Other□ Severe/challenging behavior (e.g., elopement, property destruction, self/other injury, severe
aggression)□ Cannot determine
5. Eligible study size (at least 10 total participants in target population)□ Yes □ No □ Cannot Determine
5a. Record total N with ASD:________________
C-1

Medical and Sensory-Related Therapies for Children with Autism Spectrum
Disorder Full Text Review Form
1. Study population is children with autism between the ages of 2 and 12 years (mean+SD<12 yrs, 11 months)□ Yes □ No □ Cannot Determine
2. Original research (does not include systematic reviews and meta-analyses)□ Yes □ No □ Cannot Determine
3. Is this a comparative study (includes a treatment and comparison group)?
□ Yes □ No □ Cannot Determine
4. Does this study address:□ Medical intervention□ Sensory intervention□ Other intervention□ Not an intervention study
5. Eligible study size (at least 10 total participants in RCT; 20 total participants in target
population for observational studies)□ Yes □ No □ Cannot Determine
5a. Record total N with ASD:_______________
6. Reports an outcome of interest for individuals with ASD:
□ Yes □ No □ Cannot Determine
Comments:______________________________________________________________________________
If excluded, retain for review of references or background/contextual questions?
□ Background□ Review of References□ OtherC-2

Medical and Sensory-Related Therapies for Children with Autism Spectrum
Disorder Risk of Bias Form
1. Did the study employ a group design?
□ Yes □ No
2. Were the groups randomly assigned?
□ Yes □ No □ Comments _______________________________________________________
3. Was there an appropriate comparison group?
□ Yes □ No or NR□ Comments _________________________________________________

4. If an RCT, was randomization done correctly?
□ Yes □ No □ NR □ NA (non-RCT)□ Comments ___________________________________________________________________
5. Was a valid diagnostic approach for ASD used within the study, or were referred
participants diagnosed using a valid approach?
□ A. clinical DSM-IV/5-based diagnosis + ADI-R and/or ADOS
□ B. [clinical DSM-IV/5-based diagnosis + other] OR [ADOS + other, such as SRS, CARS,
SCQ, CAST, ASSQ, OR STAT, MCHAT for under 30 months]□ C. Only clinical DSM-IV/5-based diagnosis OR Only ADOS
□ D. Neither clinical DSM-IV/5-based diagnosis NOR ADOS
□ Comments ___________________________________________________________________
6. Was the sample clearly characterized (e.g., information provided to characterize
participants in terms of impairments associated with their ASD, such as cognitive ordevelopmental level)?
□ Yes □ No or NR□ Comments _________________________________________________

7. Were inclusion and exclusion criteria clearly stated?
□ Yes □ No or NR□ Comments _________________________________________________

8. Do the authors report attrition?
□ Yes □ No □ Comments _______________________________________________________
9. Were characteristics of drop-out group evaluated for differences with the participantgroup as a whole?
C-3

□ Yes □ No or NR □ NA or minimal attrition□ Comments ___________________________________________________________________
10. Was the intervention fully described?
□ Yes □ No or NR□ Comments _________________________________________________

11. For behavioral/non-medical studies, was treatment fidelity monitored in a systematicway?
□ Yes □ No or NR □ NA
□ Comments ___________________________________________________________________
12. Did the authors measure and report adherence to the intended treatment process?
□ Yes □ No or NR□ Comments _________________________________________________

13. Did the authors report differences in or hold steady all concomitant interventions?
□ Yes □ No or NR□ Comments _________________________________________________

14. Did outcome measures demonstrate adequate reliability and validity (includinginterobserver reliability for behavior observation coding)?
□ Yes □ No or NR□ Comments _________________________________________________

15. Were the primary & secondary outcomes clearly specified a priori?
□ Yes □ No or NR□ Comments _________________________________________________

16. Were outcome data collected from sources appropriate to the target outcome (e.g.
parent report, teacher report, direct behavior observation)?
□ Yes □ No or NR□ Comments _________________________________________________

17. Were outcomes coded by individuals blinded to the intervention status of theparticipants?
□ Yes □ No or NR □ Comments _________________________________________________
18. Was an appropriate statistical analysis used?
□ Yes □ No □ Comments _______________________________________________________
19. a. For RCTs, was there an intent-to-treat analysis?
□ Yes □ No □ NA
C-4

□ Comments ___________________________________________________________________
20. b. For negative studies, was a power calculation provided?
□ Yes □ No □ NA
□ Comments ___________________________________________________________________
21. c. Did the study correct for multiple testing?
□ Yes □ No □ NA
□ Comments ___________________________________________________________________
22. d. For observational studies, were potential confounders and effect measure modifiers
captured?
□ Yes □ No □ NA
□ Comments ___________________________________________________________________
23. e. For observational studies, were potential confounders and effect measure modifiers
handled appropriately?
□ Yes □ No □ NA
□ Comments ___________________________________________________________________
24. Were outcomes measured in at least one context outside of the treatment setting?
□ Yes □ No or NR□ Comments _________________________________________________

25. Were outcomes measured in natural environments to assess generalization?
□ Yes □ No or NR□ Comments _________________________________________________

26. Were follow-up measures of outcome conducted to assess maintenance of skills at least
3 months after the end of treatment?
□ Yes □ No or NR □ NA
□ Comments ___________________________________________________________________
27. Comments______________________________________________________________________________

C-5

Appendix D. Excluded Studies
Reasons for Exclusion
X-1
Does not address interventions or outcomes of interest
X-2
Not original research
X-3
Does not include an appropriate comparison group
X-4
Does not meet sample size criterion
X-5
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Revision Date: 20150710. Publication Type:
Journal Article.X-1, X-2

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4012. Parsi K, Elster N. A Life of One's
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D-566

Group Design

Random Assignment
Appropriate Comparison
Group
Correct Randomization
Systematic Diagnostic
Approach
Clear Sample
Characterization
Clear Inclusion/ Exclusion
Criteria
Attrition Reported
Drop out Characteristics
Evaluated
Intervention Fully
Described
Treatment Fidelity
Monitored
Treatment Adherence
Measured and Reported
Concomitant Interventions
Held Steady/ Reported
Outcome Measures Reliable
and Valid
Primary OutcomesSpecified a priori
Outcome Data Collected
From Appropriate Sources
Outcomes Coded Blindly
Appropriate Statistical
Analysis

RatingAuthor Year

Appendix E. Risk of Bias Ratings

Table E-1. Risk of bias assessments

Srinivasan
20161, 2
+
+
+
+
+
+
NA
+
+
+
+
+
+
Moderate

Ghasemtabar
20153
+
+
NA
+
+
NA
+
+
+
+
High

Silva 20154
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Moderate

5

+
+
+
++
+
+
+
+
+
+
+
+
+
+
-

Woo 2015
Low

Gringras
20146
+
+
+
+
++
+
+
+
+
+
+
+
+
+
+
Moderate

Iwanaga
20147
+
+
NA
+
+
+
+
+
+
+
+
+
High

Latham
20148
+
+
+
++
+
+
+
NA
+
+
+
+
+
+
High

Porges20149(Trial 1 and
2)
+
+
+
++
+
+
+
+
High

Schaaf
201410
+
+
+
+
++
+
+
+
NA
+
+
+
+
+
+
+
+
Moderate

Thompson
201411
+
+
+
+
++
+
+
NA
+
+
+
+
+
+
+
Moderate

E-1

Random Assignment
Appropriate Comparison
Group
Correct Randomization
Systematic Diagnostic
Approach
Clear Sample
Characterization
Clear Inclusion/ Exclusion
Criteria
Attrition Reported
Drop out Characteristics
Evaluated
Intervention Fully
Described
Treatment Fidelity
Monitored
Treatment Adherence
Measured and Reported
Concomitant Interventions
Held Steady/ Reported
Outcome Measures Reliable
and Valid
Primary OutcomesSpecified a priori
Outcome Data Collected
From Appropriate Sources
Outcomes Coded Blindly
Appropriate Statistical
Analysis

+
+
NA
+
+
NA
NA
+
+
+
+
+
High

13

+
+
+
+
+
+
+
+
+
+
+
+
Moderate

Gattino201114
+
+
+
++
+
+
NA
+
+
+
+
+
+
+
+
+
Low

Pfeiffer
201115
+
+
+
+
++
+
+
+
NA
+
+
+
+
+
+
+
+
Low

Silva 201116
+
+
+
++
+
+
+
+
NA
+
+
+
+
+
+
Moderate

Piravej
200917
+
+
+
+
++
+
+
+
+
+
+
High

Silva 200918
+
+
+
+
+
+
+
+
+
+
High

Fazlioglu
200819
+
+
+
+
++
+
+
NA
+
+
+
+
High

Kim 200820
+
+
+
++
+
NA
+
+
+
+
+
High

21

Lee 2008
+
+
NA
+
+
+
+
+
+
+
High

Corbett
200722
+
+
+
++
+
+
NA
+
+
+
+
+
Moderate

Silva 200723
+
+
+
+
++
+
+
+
+
NA
+
+
+
+
+
Moderate

Mudford200024
+
+
+
+
+
+
+
+
+
+
+
Moderate

Woo 2013

E-2

RatingGroup Design

Author Year

Silva 201312

References
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spectrum disorders: a pilot study. Am J Occup Ther 2011 JanFeb;65(1):76-85. PMID: 21309374.
16. Silva LM, Schalock M, Gabrielsen K. Early intervention for
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17. Piravej K, Tangtrongchitr P, Chandarasiri P, et al. Effects ofThai traditional massage on autistic children's behavior. J
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PMID: 10755175.

E-4

Appendix F. Applicability of Findings
Table F-1. Applicability of evidence for sensory integration
DomainPopulation
Intervention
Comparators

Outcomes
Setting

Description of applicability of evidence
Studies included children ages 2 up to 12 years and vast majority were males (80% or higher in all
studies). Most studies included children with difficulty processing and integrating sensory
information. Mean IQ was reported in three studies with values ranging from 90 to 110. The fourth
study recruited children aged 7 to 11 from a special education program the majority of whom werenon-verbal. Participants were often receiving concomitant behavioral and or pharmacologicaltreatments.
Sensory integration.
Comparators included fine motor intervention, group therapy and usual care.
Outcomes included sensory problems, cognition, verbal, motor, speech, and behavior. Assessment
using Japanese version of MAP, Goal Attainment Scaling, Pediatric Evaluation of Disability
Inventory, PDDBI, VABS, Sensory Evaluation for Children, Sensory Processing Measure, andSocial Responsiveness Scale. Treatment duration ranged from 6 weeks up to 10 months with nolong-term follow-up.
Two studies were conducted in the United States and one each in Japan and Turkey.

PDDBI = Pervasive Developmental Disorders Behavior Inventory; VABS = Vineland Adaptive Behavior Scale; MAP = Miller Assessment for
Preschoolers

Table F-2. Applicability of evidence for environmental enrichment
DomainPopulation
Intervention
Comparators

Outcomes
Setting

Description of applicability of evidence
Participants ranged in age from 3 to 12 years old and were exclusively male in one study. The
second study restricted to ages 3 to 6 and included a small number of female participants (14%).
Most were receiving concomitant behavior therapies. Autism diagnosis was confirmed by ADOS
scoring in both studies.
Sensorimotor enrichment- daily exposure to multiple sensori motor stimuli.
The comparator for both studies was standard care.
Outcomes included change in autism severity measured by CARS and ADOS and cognition
determined by Leiter-R Visualization and Reasoning scores. Sensory reactivity was assessedusing the Short Sensory Profile. Interventions were 6 months duration in both studies.
Both studies were conducted at the same academic medical center in the United States.

ADOS = Autism Diagnostic Observation Scale; CARS = Childhood Autism Rating Scale

Table F-3. Applicability of evidence for auditory integration
DomainPopulation
Intervention
Comparators

Outcomes
Setting

Description of applicability of evidenceChildren ranged from ages 3-13 years. All participants had a diagnosis of autism and were lowfunctioning, having significant cognitive and/or language delays.
Auditory integration using the Tomatis method or a more generalized training protocol.
Both studies used a crossover design comparing auditory integration to placebo within individual
subjects.
Outcomes included behavior, cognitive and language skills obtained from direct observation andparent reports. Assessment tools used included VABS, Reynell Language Development Scales,
Leiter International Performance Scale, ADOS, Stanford- Binet Intelligence Scale, Peabody Picture
Vocabulary test, and Expressive One Word Vocabulary test. Both interventions were less than 1month duration.
One study was conducted in the United States and one in the United Kingdom.

ADOS = Autism Diagnostic Observation Scale; VABS = Vineland Adaptive Behavior Scale

F-1

Table F-4. Applicability of evidence for music therapy
DomainPopulation
Intervention
Comparators

Outcomes
Setting

Description of applicability of evidence
Most studies were conducted in preschool aged children except for two studies that included
children up to age 12. The severity of ASD varied widely with some studies including mild tomoderate ASD and others including children with severe ASD based on CARS scores andincluding verbal and non-verbal participants.
Music therapy, filtered music.
Comparators included unfiltered music, headphone control, toy play, robotic interventions, tabletop
activities, and no intervention
Outcomes included social engagement, social skills, speech and language, joint attention and nonverbal social communication, and hearing sensitivity. The instruments used to assess changes
included VSEEC, SSRS, PDDBI, ESCS, measures of joint attention, and parent questionnaires onhearing sensitivity. Interventions were of short duration ranging from 1 up to 16 weeks with no longterm follow-up. One Iranian study in school-aged children assessed social skills two months after
intervention.
Studies were conducted in the United States, Brazil, Australia, Korea and Iran.

CARS = Childhood Autism Rating Scale; VSEEC = Vineland Social-Emotional Early Childhood ; SSRS = Social Skills Rating System; PDDBI= Pervasive Developmental Disorders Behavior Inventory; ESCS = Early Social Communication Scales

Table F-5. Applicability of evidence for massage/touch therapy
DomainPopulation
Intervention
Comparators

Outcomes
Setting

Description of applicability of evidence
Participants ranged in age from 3 to 16 years across studies. Majority of study participants weremale. The severity of ASD including degree of intellectual disability was not well characterized.
Qigong sensory massage, other massage
Comparators were observation or waitlist controls andmassage plus sensory intervention andattachment therapy alone.
Outcomes included sensory impairment, adaptive behavior, autistic behavior, language skills,social abilities, and bowel and sleep abnormalities. Measurement instruments included Sensory
Profile, ABC, VABS, PDDBI, and parent questionnaires to describe bowel and sleep patterns. The
massage studies were of 4-5 months duration.
Studies were conducted in the United States and Korea

ABC = Autism Behavior Checklist; VABS = Vineland Adaptive Behavior Scale; PDDBI = Pervasive Developmental Disorders Behavior
Inventory

F-2

Appendix G. Detailed Table of Findings
Table G-1. Key findings in studies of interventions targeting sensory challenges
Author, Year
Mean Age,
Outcome
OutcomeYears ± SD
Measure/Baseline
Measure/PostStudy Design
Scores, Mean ± SD
Treatment Scores,
Mean IQ ± SD
mean ± SD
Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
Sensory Integration-based
Approaches
1
Iwanaga 2014
Retrospective Cohort
G1: Sensory integration therapy(SIT), 8/8
G2: Group therapy (GT), 12/12
8 – 10 months/EOTHigh ROB

Age, months
G1: 56.8 ± 9.0
G2: 56.3 ± 6.8

Japanese Miller
Assessment for
Preschoolers

IQ
G1: 100.7 ±9.6
G2: 94.8 ± 9.1

Total Score
G1: ND
G2: ND
Index Score
G1: ND
G2: ND
Coordination Index
Score
G1: ND
G2: ND
Nonverbal Index
Score
G1: ND
G2: ND
Complex Index
Score
G1: ND
G2: ND
Verbal Index Score
G1: ND
G2: ND

Mean change scorefrom baseline
Japanese Miller
Assessment for
Preschoolers(mean gain)
Total Score
G1: 34.38 ± 21.98
G2: 8.25 ± 11.69
G1 vs. G2: p=0.005
Foundation Index
Score
G1: 34.13 ± 34.21
G2: 11.33 ± 25.54
G1 vs. G2: p=ns
Coordination Index
Score
G1: 46.75 ± 36.26
G2: 8.92 ± 17.87
G1 vs. G2: p=0.008
Nonverbal Index Score
G1: 45 ± 24.26
G2: 8.25±36.6
G1 vs. G2: p=0.016
Complex Index Score
G1: 30.75 ± 20.73
G2: 3.83 ± 31.2
G1 vs. G2: p=0.034
Verbal Index Score
G1: 13 ± 44.26
G2: 14.67±31.2
G1 vs. G2: p=ns

G-1

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
2
Schaaf 2014
RCT
G1: Sensory integration, 17/17
G2: Usual care, 15/14
10 weeks/EOT
Moderate ROB

Age, months
G1: 71.35 ±14.90
G2: 72.33 ±
10.81
IQ (Full scale)G1: 89.75 ±18.74
G2: 91.86 ±11.93

Goal Attainment
Scaling (GAS)G1: ND
G2: ND
Pediatric Evaluationof Disability
Inventory (PEDI)
Functional skills Self-Care
G1: ND
G2: ND
Functional skills Mobility
G1: ND
G2: ND

Mean change scorefrom baseline
Goal Attainment
Scaling (GAS)
G1: 56.53 ± 12.38
G2: 42.71 ± 11.21
G1 vs. G2: p=0.003
Pediatric Evaluation of
Disability Inventory(PEDI)
Change scores
Functional skills - SelfCare
G1: 10.2 ± 22.6
G2: 1.12 ± 5.6
G1 vs. G2: p=ns

Functional skills Social
G1: ND
G2: ND

Functional skills Mobility
G1: 6.57 ± 23.8
G2: 6.38 ± 15.1
G1 vs. G2: p=ns

Caregiverassistance – Selfcare
G1: ND
G2: ND

Functional skills Social
G1: 9.3 ± 17.4
G2: 4.4 ± 13.8
G1 vs. G2: p=ns

Caregiverassistance – Mobility
G1: ND
G2: ND

Caregiver assistance –Self-careG1: 16.6 ± 23
G2: -0.43 ± 8.6
G1 vs. G2: p=0.008

Caregiverassistance – Social
G1: ND
G2: ND
Pervasive
Developmental
Disorders Behavior
Inventory (PDDI)
G1: ND
G2: ND

G-2

Caregiver assistance –Mobility
G1: 4.8 ± 24.1
G2: 0.22 ± 11.8
G1 vs. G2: p=ns
Caregiver assistance –Social
G1: 14.4 ± 23.4
G2: -1.8 ± 19

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
G1 vs. G2: p=0.039
Vineland Behavior
Scales-II (VABS)
G1: ND
G2: ND

Pervasive
Developmental
Disorders Behavior
Inventory (PDDI)
Change scores
S/P Approach
G1: -5.9 ± 10.8
G2: -0.67 ± 5.9
G1 vs. G2: p=ns
R/R
G1: -6.5 ± 13.7
G2: -1.77 ± 6.3
G1 vs. G2: p=ns
ArouseG1: -7.1 ± 11.6
G2: -3.3 ± 6.0
G1 vs. G2: p=ns
Vineland Behavior
Scales-II (VABS)
Change scores
Communication
G1: 5.06 ± 10.9
G2: -3.38 ± 18.6
G1 vs. G2: p=ns
Daily Living Skills
G1: 4.2 ± 11.6
G2: -3.0 ± 18.5
G1 vs. G2: p=ns
Socialization
G1: 3.8 ± 11.8
G2: -6.7 ± 21.8
G1 vs. G2: p=ns
Composite
G1: 15.1 ± 44.7
G2: 0.0 ± 8.1
G1 vs. G2: p=ns

G-3

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
3
Pfeiffer 2011
RCT
G1: SI treatment, 20/20
G2: Fine motor, 17/17
6 weeks/EOT

Age, months
G1: 100.00 ±24.78
G2: 110.47 ±
24.78
IQ
NR

Low ROB

Vineland Adaptive
Behavioral Scales
Communication
G1: 62.90 ± 13.39
G2: 64.24 ± 9.62
Socialization
G1: 63.90 ± 17.71
G2: 64.24 ± 9.33
Motor
G1: 60.70 ± 13.20
G2: 61.00 ± 11.24
Composite
G1: 66.80 ± 16.66
G2: 70.18 ± 14.07
Sensory Processing
Measure - Total
G1: 68.50 ± 5.62
G2: 67.88 ± 7.28

4

Fazlioglu et al. 2008
RCT

Age
G1 + G2: 7-11

G1: Sensory Integration, 15/15
G2: Control (Special
Education), 15/15

IQ
NR

SocialResponsiveness
Scale - Total
G1: 82.95 ± 6.37
G2: 82.71 ± 9.10
Sensory Evaluation
Form for Children
with Autism
G1: 98.2 ± 19.3
G2: 95.8 ± 17

12 weeks/EOTHigh ROB
Environmental Enrichmentbased Approaches

G-4

EOT
Vineland Adaptive
Behavioral ScalesNR
Sensory Processing
Measure - Total
G1 vs. G2: p=ns
Social Responsiveness
Scale - Total
G1 vs. G2: p=ns
GAS-Parent rated
G1 > G2
G1 vs. G2: p<0.05;
ES=0.125
GAS-Teacher rated
G1 > G2
G1 vs. G2: p<0.01;
ES=0.360

Sensory Evaluation
Form for Children with
Autism
G1: 66.5 ± 11.4
G2: 97.3 ± 17.8
G1 vs. G2: p<0.05

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias5
Woo 2013
RCT
G1: Sensorimotor enrichmentgroup + standard care, 13/13
G2: Standard care, 15/15

Age
G1 + G2: 6.6
± 2.5
IQ
NR

6 months/EOT

CARS – Autism
Severity, mean ± se
G1: 34.38 ± 0.72
G2: 38.07 ± 1.71
Leiter-R – Nonverbal
Test Scale
G1: 48.46 ± 5.52
G2: 46.2 ± 6.36

Moderate ROB
EOWPV –
Expressive
Language Scale
G1: ND
G2: ND6

Woo 2015
RCT

G1: Standard care +sensorimotor enrichment, 64/28
G2: Standard care, 27/22
6 months/EOT
Low ROBAge
G1: 4.76 ±1.14
G2: 4.54 ±1.10
IQ
G1: 82.96 ±5.17
G2: 76.63 ±4.96

ADOS – Severity
G1: ND
G2: ND
RDLS
Receptive Language
G1: 36.19 ± 4.64
G2: 33.37 ± 4.79
Expressive
Language
G1: 31.46 ± 4.14
G2: 31.47 ± 4.82
Leiter-R
Nonverbal Test
Score
G1: 35.85 ± 4.76
G2: 32.63 ± 6.07
IQ Score
G1: 82.96 ± 5.17
G2: 76.63 ± 4.96
SSP – AtypicalSensory Responses
G1: 113.75 ± 4.76

G-5

EOT
CARS – Autism
Severity
G1: 31.12 ± 1.46
G2: 37.61 ± 1.67
G1 vs. G2: p=0.03
Leiter-R – Nonverbal
Test Scale
G1: 57.23 ± 5.5
G2: 43.7 ± 6.89
G1 vs. G2: p=0.008
Change in
EOWPV – Expressive
Language Scale
G1: 4.7
G2: 4.67
G1 vs. G2: p=ns
EOT
ADOS – Severity
G1: 6 (21)G2: 0 (0)G1 vs. G2: p=0.01
RDLS
Receptive Language
G1: 43.62 ± 4.14
G2: 37 ± 4.95
G1 vs. G2: p=0.048
Expressive Language
G1: 38.65 ± 4.16
G2: 37.16 ± 4.94
G1 vs. G2: p=ns
Leiter-R
Nonverbal Test Score
G1: 49.19 ± 5.48
G2: 40.05 ± 6.25
G1 vs. G2: p=0.024
IQ Score
G1: 91.38 ± 5.58
G2: 78.16 ± 4.49
G1 vs. G2: p=0.037

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
G2: 129.3 ± 4.29
SSP – Atypical Sensory
Responses
G1: 125.11 ± 5.42
G2: 132.15 ± 4.09
G1 vs. G2: p=0.037
Auditory Integration-based
Approaches
7
Mudford 2000
RCT
G1: Auditory integration, 21/21
G2: Control Treatment, 21/21
10 days (2 session/day)/EOTAge
G1 + G2: 9.42
years ± 29
monthsIQ
NR

ABC-Hyperactivity
23.7 ± 9.4
NCBRFHyperactivity
13.9 ± 5.5

NCBRF-Hyperactivity
G1: -0.3 ± 2
G2: -2 ± 2.2

Moderate ROB

Corbett 2008
RCT

8

Age
G1 + G2: 3-7

G1: Tomatis Sound
Therapy/Placebo, 11/11
G2: Placebo/Tomatis Sound
Therapy, 11/11

IQ (range)
G1 + G2: 5283

Mean change frombaseline
ABC-Hyperactivity
G1: 0.3 ± 3.6
G2: -4.1 ± 3.9

PPVT
G1: 20.83 ± 28.52
G2: 32.20 ± 25.21
EOWVT
G1: 16.50 ± 21.11
G2: 25.20 ± 19.82

25 days (2 blocks)/EOT
Moderate ROB

G-6

EOT
PPVT
G1: 22.83 ± 29.36
G2: 47.20 ± 24.45
EOWVT
G1: 21.50 ± 23.30
G2: 34.40 ± 25

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Parent questionnaire

EOT
Parent questionnaire
Hearing sensitivity
G1: 9 (50)G2: 1 (8)
G1 vs. G2: p=0.017

Mean IQ ± SD
Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
9
Porges 2014
RCT

Age
NR

G1: Filtered music, 28/28
G2: Headphones only, 36/36

IQ
NR

1 week/EOTHigh ROB

Hearing sensitivity
G1: 18 (50)G2: 12 (43)AffectG1: 16 (44)G2: 17 (61)
Eye contact
G1: 27 (75)
G2: 17 (61)Behavioralorganization
G1: 19 (53)G2: 16 (57)
Emotional control
G1: 18 (50)G2: 12 (43)Spontaneous
speech
G1: 27 (75)
G2: 23 (82)
Receptive speech
G1: 26 (72)G2: 23 (82)
Listening
G1: 29 (81)G2: 24 (86)Spontaneity
G1: 25 (69)G2: 20 (71)
Relatedness
G1: 30 (83)
G2: 23 (82)G-7

AffectG1: 3 (19)G2: 1 (18)
Eye contact
G1: 11 (41)
G2: 4 (24)Behavioral organization
G1: 5 (26)G2: 0 (0)G1 vs. G2: p=0.027
Emotional control
G1: 3 (17)G2: 0 (0)Spontaneous speech
G1: 13 (48)
G2: 4 (17)
G1 vs. G2: p=0.022
Receptive speech
G1: 8 (31)G2: 2 (9)Listening
G1: 12 (41)G2: 2 (8)
G1 vs. G2: p=0.006
Spontaneity
G1: 12 (48)
G2: 4 (20)
Relatedness
G1: 9 (30)
G2: 3 (13)Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Parent questionnaire
Hearing sensitivity
G1: 23 (46)G2: 16 (50)

EOT
Parent questionnaire
Hearing sensitivity
G1: 10 (43)G2: 2 (13)
G1 vs. G2: p=0.040

Mean IQ ± SD
Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
9
Porges 2014
RCT
G1: Filtered music, 50/50
G2: Unﬁltered music, 32/32
1 week/EOT

Age, months
G1: 53.33 ±15.95
G2: 56.74 ±
9.25
IQ
NR

AffectG1: 32 (64)G2: 19 (59)High ROB
Eye contact
G1: 30 (60)G2: 20 (63)Behavioralorganization
G1: 28 (56)G2: 17 (53)Emotional control
G1: 33 (66)G2: 19 (59)Spontaneous
speech
G1: 41 (82)
G2: 25 (78)
Receptive speech
G1: 45 (90)G2: 26 (81)
Listening
G1: 37 (74)G2: 21 (66)
Spontaneity
G1: 22 (44)G2: 14 (44)
Relatedness
G1: 32 (64)G2: 21 (66)Music Therapy-based
Approaches
10, 11
Srinivasan 2016

Age

Training SpecificG-8

AffectG1: 8 (25)
G2: 4 (21)
Eye contact
G1: 10 (33)
G2: 8 (40)
Behavioral organization
G1: 8 (29)
G2: 3 (18)
Emotional control
G1: 8 (24)G2: 0 (0)G1 vs. G2: p=0.019
Spontaneous speech
G1: 21 (51)G2: 11 (44)
Receptive speech
G1: 4 (9)G2: 4 (15)Listening
G1: 11 (30)
G2: 6 (29)
Spontaneity
G1: 8 (36)G2: 5 (36)
Relatedness
G1: 11 (34)G2: 6 (29)

Joint Attention Test –Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Measure –Response to Social
Bids (total word
count) Early
NR

Total Score
G1 vs G2 vs G3, p=NS;
SMD=0.55, CI (SMD)=0.13 to 1.24

Mean IQ ± SD
Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
RCT

G1 + G2: 5-12

G1: Rhythm Group, 12/11
G2: Robot Group, 12/11
G3: Standard Care, 12/11

IQ
NR

8 weeks/EOT
Moderate ROB

Training SpecificMeasure –Response to Social
Bids (total word
count) Mid
NR

G1 vs G2 vs G3, p=NS;
SMD=0.25, CI (SMD)=0.38 to 0.89

Training SpecificMeasure –Response to Social
Bids (total word
count) LateNR

G1 vs G2 vs G3, p=NS;
SMD=0.71, CI (SMD)=0.01 to 1.43
Training SpecificMeasure – Response
to Social Bids (total
word count) Early
G1: 4.4 ± 4.19
G2: 5.92 ± 7.04
G3: 4.5 ± 3.9

Training SpecificMeasure Verbalization tosocial partners(percent duration)
Early – TrainerNR

Training SpecificMeasure – Response
to Social Bids (total
word count) Mid
G1: 3.8 ± 3.29
G2: 7.25 ± 6.74
G3: 7.33 ± 8.81

Training SpecificMeasure Verbalization tosocial partners(percent duration)
Early - Adult ModelNR

Training SpecificMeasure – Response
to Social Bids (total
word count) Late
G1: 9.8 ± 8.53
G2: 7.67 ± 7.6
G3: 5.67 ± 4.16

Training SpecificMeasure Verbalization tosocial partners(percent duration)
Mid – TrainerNR

Training SpecificMeasure - Verbalization
to social partners(percent duration) Early– Trainer
G1: 6.1 ± 5.7
G2: 3.9 ± 4.2
G3: 12.1 ± 8.6

Training SpecificMeasure -G-9Training SpecificAuthor, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Verbalization tosocial partners(percent duration)
Mid - Adult ModelNR

Measure - Verbalization
to social partners(percent duration) Early- Adult Model
G1: 2.1 ± 2.3
G2: 1.9 ± 1.1
G3: 2 ± 1.6

Mean IQ ± SD
Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias

Training SpecificMeasure Verbalization tosocial partners(percent duration)
Late – TrainerNR
Training SpecificMeasure Verbalization tosocial partners(percent duration)
Late - Adult ModelNR
Training SpecificMeasure Vocalization patterns
NR
Training SpecificMeasure Verbalization
patterns
NR

Training SpecificMeasure - Verbalization
to social partners(percent duration) Mid– Trainer
G1: 12.8 ± 14.5
G2: 5.1 ± 5.3
G3: 14.5 ± 11.3
Training SpecificMeasure - Verbalization
to social partners(percent duration) Mid Adult Model
G1: 1.8 ± 1.9
G2: 3.4 ± 1.7
G3: 2.2 ± 1.9
Training SpecificMeasure - Verbalization
to social partners(percent duration) Late
– Trainer
G1: 14.8 ± 15
G2: 6.3 ± 6.1
G3: 14.4 ± 8.6
Training SpecificMeasure - Verbalization
to social partners(percent duration) Late
- Adult Model
G1: 2.2 ± 2.3
G2: 5.4 ± 4.2
G3: 2.6 ± 2.4
Training SpecificMeasure - Vocalization

G-10

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
patterns
G2 vs G1,G3, p<0.002;
SMD=0.75 to 0.76
Training SpecificMeasure - Verbalization
patterns
G1 vs G3, p=NS

Ghasemtabar 2015
Non-RCT

12

G1: Music therapy, 13/13
G2: Control, 14/14
45 days/EOT

Age
G1: 8.96 ±1.36
G2: 9.23 ±1.54

Social skills rating
system
G1: 27.69 ± 4.76
G2: 26.92 ± 4.49

(Follow-up 2 mos)
G1: 30.61 ± 4.25
G2: 26.85 ± 3.82

IQ
NR

High ROB
13

Thompson 2014
RCT

G1: Family-centered music
therapy (FCMT), 12/11
G2: Early intervention
programme, 11/10

Age, months
G1: 43.92 ±6.46
G2: 47.00 ±
7.18
IQ
NR

VSEEC - Social
Interaction
G1: 49.1 ± 12.4
G2: 45.09 ± 8.13
SRS
G1: 105.4 ± 27.1
G2: 106.2 ± 26.1

16 weeks/EOT
Moderate ROB

G3 vs G1,G2, p=0.001;
SMD=0.78
Social skills rating
system(EOT)
G1: 30.55 ± 4.0
G2: 27.34 ± 3.54

MBCDI
Speech andLanguage
G1: 180 ± 108
G2: 170 ± 109
PCRI
G1: 194.3 ± 23.1
G2: 191.6 ± 19.4

Change scores frombaseline
VSEEC - Social
Interaction
G1: 22.4 ± 10.1
G2: 0.9 ± 11.9
G1 vs. G2: p<0.001
SRS
G1: -7.7 ± 17.3
G2: -1.4 ± 11.5
G1 vs. G2: p=ns
MBCDI
Speech and Language
G1: 78.9 ± 73.4
G2: 58.7 ± 79.8
G1 vs. G2: p=ns
PCRI
G1: 8.0 ± 9.19
G2: 0.2 ± 10.3
G1 vs. G2: p=ns

G-11

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
14
Gattino 2011
RCT
G1: Relational music therapy +clinical routine activities, 12/12
G2: Clinical routine activities,
12/12

Age
G1 + G2: 9.75
± 1.39IQ
NR

7 months/EOT

CARS-Verbal
Communication
G1: 2.67 ± 0.49
G2: 2.54 ± 0.33
CARS-Non-Verbal
Communication
G1: 2.42 ± 0.42
G2: 2.08 ± 0.47
CARS-Social
Communications
G1: 12.29 ± 1.78
G2: 11.38 ± 1.65

Low ROB15

Kim 2008
RCT

Age, months
G1 + G2:
51.20 ± 12.08

G1: Music Therapy, 15/10
G2: Toy Play, 15/10

PDDBI
Level of agreement
at pre-Rx: 0.19

IQ
NR

CARS-Verbal
Communication
G1: 2.54 ± 0.45
G2: 2.58 ± 0.44
G1 vs G2, p=0.50;
SMD=0.39 (95% CI=
0.21 to 0.57)
CARS-Non-Verbal
Communication
G1: 2.5 ± 0.37
G2: 2.33 ± 0.54
G1 vs G2, p=0.35;
SMD=0.39 (95% CI=
0.08 to 0.86)
CARS-Social
Communications
G1: 12.25 ± 1.54
G2:11.92 ± 1.24
G1 vs G2, p=0.34;
SMD=0.39 (95%
CI=70.08 to 0.86)
PDDBI
Level of agreement at
post-Rx: 0.67
G1 vs. G2: p=ns

12 weekly, 30 min
sessions/EOTHigh ROB
Massage/Touch
Silva et al. 2015
RCT

16

G1: Qigong massage, 55/42
G2: Control, 48/42
5 months/EOT
Moderate ROB

Age
G1 + G2: 2-5
IQ
NR

Aberrant Behavior
Checklist
G1: 82.4 ± 25.9
G2: 83.1 ± 25.9
VABS-Daily Living
Skills
G1: 34.3 ± 17.7
G2: 37.5 ± 20
VABS-Socialization

G-12

Aberrant Behavior
Checklist
G1: 62.4 ± 26.6
G2: 75.7 ± 28.6
G1 vs. G2: p=0.006
VABS-Daily Living
Skills
G1: 42.7 ± 19.1
G2: 45.9 ± 22.7
G1 vs. G2: p=NR

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
G1: 36 ± 14.4
G2: 40.7 ± 17.4
Self-regulatory
difficulties
G1: 57.6 ± 11.2
G2: 57.4 ± 13.4
Abnormal Sensory
Response
G1: 39.7 ± 9.1
G2: 41.3 ± 10.3
Childhood Autism
Rating Scale – totalscore
G1: 39.7 ± 6.6
G2: 38 ± 7.8

17Silva et al. 2013
RCT

G1: Qigong massage + qigong
sensory training, 97/97
G2: Control, 32/32
5 months/EOTHigh ROB

Age
G1: 3.87 ±1.11
G2: 4.16 ±
0.95
IQ
NR

Autism Parenting
Stress Index
G1: 24.35 ± 10.62
G2: 24.42 ± 11.62
Abnormal Tactile
Response – totalscore
G1: 20.91 ± 7.13
G2: 22.31 ± 8.52
Self-regulatory
difficulties
G1: 45.43 ± 11.21
G2: 50.94 ± 15.69

G-13

VABS-Socialization
G1: 45.7 ± 16.3
G2: 48.6 ± 21
G1 vs. G2: p=NR
Self-regulatory
difficulties
G1: 45.1 ± 11.5
G2: 54 ± 14.5
G1 vs. G2: p=0.00006
Abnormal Sensory
Response
G1: 30.4 ± 9.8
G2: 38.6 ± 11.6
G1 vs. G2: p=0.00002
Childhood Autism
Rating Scale – totalscore
G1: 38.2 ± 6.6
G2: 37.7 ± 7.8
G1 vs. G2: p=ns
Autism Parenting
Stress Index
G1: 15.76 ± 8.16
G2: 21.53 ± 11.08
G1 vs. G2: p=0.001
Abnormal Tactile
Response – total score
G1: 15.57 ± 6.86
G2: 21.34 ± 8.41
G1 vs. G2: p<0.001
Self-regulatory
difficulties
G1: 34.3 ± 10.88
G2: 49.03 ± 15.45
G1 vs. G2: p<0.001

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
18
Silva 2011
RCT

Age, months
G1 + G2: 58

G1: Qigong massage, 28/24
G2: Wait-list control, 19/18

IQ
NR

Teacher ABC
Autism Severityscore
G1: 76.3 ± 19.6
G2: 76.7 ± 30.1
PDDBI
Sensory
G1: 56.4 ± 10.6
G2: 56.5 ± 11.5

4 months/EOT
Moderate ROB

Maladaptive
Behavior
G1: 60.9 ± 13.0
G2: 61.8 ± 15.8
Social/Language/Co
mmunication
Abilities
G1: 49.9 ± 11.4
G2: 51.6 ± 12.1
SSC
Sense
G1: 38.1 ± 12.1
G2: 40.6 ± 14.6
Self-Regulation
G1: 49.1 ± 11.7
G2: 48.9 ± 12.7
Autism Composite
Score
G1: 59.8 ± 11.1
G2: 60.2 ± 15.9

19

Piravej 2009
RCT

G1: Traditional Thai massage +sensory integration therapy,
30/30

Age
G1: 4.84 ±1.86
G2: 4.48 ± 1.8

CPRS-Conduct
Problem
G1: 0.69 ± 0.31
G2: 0.59 ± 0.34

IQ

CPRS-Learning

G-14

EOT
ABC
Autism Severity score
G1: 56.1 ± 26.4
G2: 75.3 ± 38.9
G1 vs. G2: p=ns
PDDBI
Sensory
G1: 50.1 ± 11.8
G2: 55.6 ± 10.0
G1 vs. G2: p=0.032
Maladaptive Behavior
G1: 52.3 ± 14.9
G2: 61.3 ± 15.2
G1 vs. G2: p=0.003
Social/Language/Com
munication Abilities
G1: 53.0 ± 10.7
G2: 53.1 ± 12.2
G1 vs. G2: p=ns
SSC
Sense
G1: 28.5 ± 12.2
G2: 39.4 ± 12.6
G1 vs. G2: p=0.001
Self-Regulation
G1: 39.2 ± 14.7
G2: 49.2 ± 11.6
G1 vs. G2: p=0.00002
Autism Composite
Score
G1: 50.9 ± 14.8
G2: 58.9 ± 12.3
G1 vs. G2: p=NR
CPRS-Conduct
Problem
G1: 0.6 ± 0.26
G2: 0.63 ± 0.33
G1 vs. G2, p=0.03

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
G2: Sensory integration
therapy, 30/30

ND

Problem
G1: 1.86 ± 0.55
G2: 2.02 ± 0.56

8 weeks/EOTHigh ROBCPRSPsychosomatic
G1: 0.41 ± 0.45
G2: 0.43 ± 0.34
CPRS-ImpulsivityHyperactivity
G1: 1.62 ± 0.6
G2: 1.65 ± 0.65
CPRS-Anxiety
G1: 0.76 ± 0.53
G2: 0.62 ± 0.49

CPRS-Learning
Problem
G1: 1.76 ± 0.48
G2: 1.87 ± 0.53
G1 vs. G2, p=ns
CPRS-Psychosomatic
G1: 0.41 ± 0.32
G2: 0.39 ± 0.25
G1 vs. G2, p=ns
CPRS-ImpulsivityHyperactivity
G1: 1.44 ± 0.4
G2: 1.69 ± 0.57
G1 vs. G2, p=ns

CPRS-Hyperactivity
G1: 1.45 ± 0.51
G2: 1.53 ± 0.48

CPRS-Anxiety
G1: 0.62 ± 0.56
G2: 0.73 ± 0.5
G1 vs. G2, p=0.01

CTRS-Conduct
Problem
G1: 0.98 ± 0.38
G2: 1.11 ± 0.27

CPRS-Hyperactivity
G1: 1.32 ± 0.41
G2: 1.42 ± 0.42
G1 vs. G2, p=ns

CTRS-Hyperactivity
G1: 1.59 ± 0.49
G2: 1.8 ± 0.36

CTRS-Conduct
Problem
G1: 0.64 ± 0.35
G2: 0.71 ± 0.26
G1 vs. G2, p=ns

CTRS-InattentionPassivity
G1: 1.56 ± 0.41
G2: 1.67 ± 0.27
CTRS-Hyperactivity
Index
G1: 11.5 ± 9.23
G2: 13.9 ± 7.67
Sleep Diary
G1: 11.5 ± 9.23
G2: 13.9 ± 7.67

CTRS-Hyperactivity
G1: 1.24 ± 0.5
G2: 1.49 ± 0.37
G1 vs. G2, p=ns
CTRS-InattentionPassivity
G1: 1.18 ± 0.51
G2: 1.34 ± 0.36
G1 vs. G2, p=ns
CTRS-Hyperactivity
Index

G-15

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
G1: 1.1 ± 0.49
G2: 1.28 ± 0.4
G1 vs. G2, p=ns
Sleep Behavior-Sleep
Diary
G1: 5.33 ± 3.28
G2: 8.2 ± 6.83
G1 vs. G2, p=ns20

Silva et al. 2009
RCT

G1: Qigong Sensory Training,
25/25
G2: Waitlist Control, 21/21
5 months/EOT

Age, months
G1: 65.2 ±20.7
G2: 53.3 ±
18.7
IQ
NR

ABC – total score
G1: 48.5 ± 20.8
G2: 64.3 ± 33.8
PDDI – Maladaptive
Behavior Score(Parent)
G1: 56.8 ± 11.5
G2: 59.5 ± 10.7

High ROBPDDI - Maladaptive
Behavior Score(Teacher)G1: 50.9 ± 10.4
G2: 56.5 ± 13.3
PDDI –
Social/Language/Co
mmunication score(Parent)
G1: 57.5 ± 6.8
G2: 49 ± 13.1
PDDI –
Social/Language/Co
mmunication score(Teacher)G1: 53.7 ± 9.7
G2: 47 ± 13
PDDI – Sensory
score (Parent)
G1: 54.2 ± 9.6
G2: 56 ± 9.6

ABC – total score
G1: 33.9 ± 18.6
G2: 59.4 ± 35.4
G1 vs. G2: p=0.003
PDDI – Maladaptive
Behavior Score(Parent)
G1: 45.6 ± 10.8
G2: 57.5 ± 10.4
G1 vs. G2: p=0.0003
PDDI - Maladaptive
Behavior Score(Teacher)G1: 44 ± 7.6
G2: 49.7 ± 12.2
G1 vs. G2: p=ns
PDDI –
Social/Language/Com
munication score(Parent)
G1: 56.7 ± 9.7
G2: 49.2 ± 12.8
G1 vs. G2: p=0.007
PDDI –
Social/Language/Com
munication score(Teacher)G1: 56.7 ± 9.7
G2: 47.6 ± 12.1
G1 vs. G2: p=0.010
PDDI – Sensory score

G-16

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias21

Lee 2008
Prospective cohort
G1: Massage therapy +attachment promotion program,
23/23
G2: Attachment promotion
program, 21/21

Age, months
G1: 19 ± 4
G2: 9 ± 12
IQ
NRSocial Maturity
Scale
G1: 63.13 ± 15.76
G2: 51.24 ± 10.48(Parent)
G1: 46.2 ± 9.1
G2: 55.3 ± 10
G1 vs. G2: p=0.005
Social Maturity Scale
G1: 70.74 ± 16.39
G2: 52.86 ± 10.18
G1 vs G2, p=0.005

CARS-Total Score
G1: 44.31 ± 0.57
G2: 41.76 ± 5.07

CARS-Total Score
G1: 37.74 ± 7.49
G2: 39.19 ± 5.43
G1 vs G2, p=NS

VABS-Living Skills
G1: 28.8
G2: 24.1

Mean Change Score
from baseline
VABS-Living Skills
G1: 9.8
G2: 0.9
G1 vs. G2: p=0.02

4 months/EOTHigh ROB
22
Silva 2007
RCT

Age
G1 + G2: 2-6

G1: Qigong Massage, 8/8
G2: No Treatment, 7/7

IQNR

5 months/EOT
Moderate ROB

VABS-Socialization
G1: 29.8
G2: 24.7
VABS-Receptive
Language
G1: 33.8
G2: 23.6
VABS-Expressive
Language
G1: 31.5
G2: 24.4
VABS-Gross Motor
Skills
G1: 37.5
G2: 33.4
VABS-Fine Motor
Skills
G1: 36
G2: 29
Short Sensory
Profile – Total Score

G-17

VABS-Socialization
G1: 10G2: 4.7
G1 vs. G2: p=0.04
VABS-Receptive
Language
G1: 8.3
G2: 10.6
G1 vs. G2: p=ns
VABS-Expressive
Language
G1: 8.9
G2: 6.7
G1 vs. G2: p=ns
VABS-Gross Motor
Skills
G1: 6.5
G2: 0.9
G1 vs. G2: p=ns

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
G1: 16.2
G2: 15.7
ABC-Total Score
G1: 71.3
G2: 87.7

VABS-Fine Motor Skills
G1: 8.8
G2: 7.6
G1 vs. G2: p=ns
Short Sensory Profile –Total Score
G1: -5.4
G2: 2.7
G1 vs. G2: p=0.01
ABC-Total Score
G1: -13.3
G2: -24.3
G1 vs. G2: p=ns

Tactile Input
23

Latham 2014
RCT

G1: Participation (tactualkinesthetic experience), 17/17
G2: Observation, 17/17

Age
G1: 8.36 ± 2.6
G2: 8.69 ± 3.0
IQNR

24-48 hours/EOTHigh ROB

Weighted Blankets
24
Gringras 2014
RCT
G1: Weighted blanket, 36/27
G2: Control blanket, 37/27

Age
G1: 8.7 ± 3.3
G2: 9.9 ± 2.8
IQ

Verbal Scoring

Verbal Scoring

Day 1 – Verbal 1
G1: 8.12 ± 5.52
G2: 6.00 ± 5.20
G1 vs. G2: p=0.041

Day 2 – Verbal 3
G1: 8.35 ± 6.06
G2: 5.39 ± 4.76
G1 vs. G2: p=0.031

Day 1 – Verbal 2
G1: 7.76 ± 5.51
G2: 5.74 ± 5.41
G1 vs. G2: p=0.065

Day 2 – Verbal 4
G1: 8.25 ± 5.62
G2: 5.66 ± 5.02
G1 vs. G2: p=0.017

Non-Verbal Scoring

Non-Verbal Scoring

Day 1 – Score 1
G1: 8.10 ± 1.97
G2: 4.60 ± 3.42
G1 vs. G2: p=0.001

Day 2 - Score 2
G1: 8.35 ± 1.66
G2: 6.13 ± 3.47
G1 vs. G2: p=0.010

Day 1 – Rating 1
G1: 2.95 ± 1.08
G2: 3.90 ± 1.16
G1 vs. G2: p=0.010

Day 2 – Rating 2
G1: 2.88 ± 0.96
G2: 3.57 ± 1.23
G1 vs. G2: p=0.020% of time blanket inplace, n=67
G1: 75.6 ± 25.4
G2: 73.7 ± 25.7

EOT
% of time blanket inplace
G1 vs. G2: p=ns

G-18

Author, Year

Mean Age,Years ± SD

Study Design

Outcome
Measure/Baseline
Scores, Mean ± SD

Mean IQ ± SD

Outcome
Measure/PostTreatment Scores,
mean ± SD

Groups, N Enrollment / N final
Treatment Duration/Follow-up
Time Point Post-Treatment
Risk of Bias
Crossover trial 73/54
2 weeks/EOT

NR

TST, n=67
G1: 528.9 ± 127.1
G2: 513.0 ± 154.1

Moderate ROB
SOL min, n=67
G1: 55.6 ± 37.8
G2: 57.2 ± 42.8
Proportion of nights
with ≥ 1 wake, n=67
G1: 0.2 ± 0.3
G2: 0.2 ± 0.3
Average timeawake, n=67
G1: 15.6 ± 13.4
G2: 14.6 ± 13.3
TST min, n=65/66
G1: 454.4 ± 62.4
G2: 457.7 ± 64.6
SOL min, n=59
G1: 74.3 ± 48.7
G2: 69.9 ± 43.8
Sleep efficiency, %,n=59
G1: 73.4 ± 9.3
G2: 74.2 ± 7.8
No. of nightwakenings, n=65/66
G1: 19.1 ± 6.7
G2: 19.5 ± 6.9

TST
G1 vs. G2: p=ns
SOL min
G1 vs. G2: p=ns
Proportion of nights
with ≥ 1 wake
G1 vs. G2: p=ns
Average time awake
G1 vs. G2: p=ns
TST min
G1: 452.8 ± 65.0
G2: 455.4 ± 65.8 p=ns
SOL min
G1: 71.4 ± 48.2
G2: 70.6 ± 44.3 p=ns
Sleep efficiency, %,G1: 73.6 ± 9.3
G2: 74.2 ± 8.0 p=ns
No. of night wakenings
G1: 19.5 ± 7.0
G2: 19.5 ± 6.8 p=ns
Time awake after sleep
onset
G1: 84.6 ± 42.6
G2: 84.5 ± 41.5 p=ns

Time awake after
sleep onset,
n=65/66
G1: 84.1 ± 43.1
G2: 83.8 ± 41.4
PDDBI = Pervasive Developmental Disorders Behavior Inventory; VABS = Vineland Adaptive Behavior Scale; MAP = Miller Assessment for
Preschoolers; EOT = End of Treatment; GAS = Goal Attainment Scaling; PEDI = Pediatric Evaluation of Disability Inventory; CARS =Childhood Autism Rating Scale; Leiter-R = Leiter International Performance Scale-Revised; EOWPV = Expressive One-Word Picture
Vocabulary Test; ADOS = Autism Diagnostic Observation Schedule; RDLS = Reynell Developmental Language Scales; SSP = Short Sensory

G-19

Profile; ABC = Autism Behavior Checklist; NCBRF = Nisonger Child Behavior Rating Form; PPVT = Peabody Picture Vocabulary Test;
EOWVT = Expressive One Word Vocabulary Test; VSEEC = Vineland Social-Emotional Early Child-hood Scales; SRS = Social
Responsiveness Scale; MBCDI = MacArthur-Bates Communicative Development Inventories; PCRI = Parent–Child Relationship Inventory;
SC = Sense and Self-Regulation Checklist; TST = Total Sleep Time; SOL = Sleep Onset Latency

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G-21