Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
Phase: NA
Conditions: Stress
Sponsor: Massachusetts General Hospital

Official Title of Study: Evaluation of a resiliency intervention for parents of children with Autism 
Spectrum Disorder (ASD)
NCT number: NCT02995408
Date of document: 1/14/21 

1 
PARTNERS HUMAN RESEARCH COMMITTEE DETAILED PROTOCOL 
Date: 1/14/21 
I. BACKGROUND AND SIGNIFICANCE
According to the Center for Disease Control in 2012, 14.6 per 1,000 children aged 8 
years old have a diagnosis of Autism Spectrum Disorder (ASD).1 Having a child with ASD is 
associated with medical expenditures of 4.1-4.6 times more than having a child without autism, 
and associated with 8.4-9.5 times greater general expenditures.2 Furthermore, children with ASD 
are more likely to use out-of-school behavioral health services than children without 
developmental or psychiatric diagnoses.3 Parents of children with ASD consistently show high 
levels of perceived distress and anxiety related to child-parent relationships, intellectual 
functioning, adaptive behaviors,4,5,6 in addition to poorer health than parents of children of 
typical development.7 These parents also exhibit significant stress related to the emotional and 
financial challenges of putting together treatment and future-related plans for their children.8 
Recent studies have found a positive relationship between caregivers’ stress levels while raising 
a child with ASD and child behavioral and conduct problems.9,10,11,12,13 
There is growing literature on the increased levels of parental stress associated with 
caring for children with ASD. One study found that caregivers of children with ASD with 
behavioral, hyperactivity, and emotional problems displayed atypical cortisol patterns, a 
biological marker of increased stress.9  A review article provides a comprehensive overview of 
the links between high levels of parental stress among parents of children with intellectual and 
developmental disabilities and child health and well-being.14 In addition to social phobias 
associated with children with ASD,15 one study even found that caring for a child with ASD 
showed higher stress levels for the parents correlated with the child’s social impairment 
severeity.11 Finally, recent studies have also found that many parents of children with ASD 
exhibit psychological and physical depressive symptoms.16 Therefore, having a children with 
ASD is associated with an increased risk of problems with emotional and physical health and 
social well-being. Resiliency is a multidimensional construct that refers to the ability to maintain 
adaptation and effective functioning when faced with stressors.  
Resiliency provides a framework for understanding the adjustment to stress as a dynamic 
process. Allostasis refers to the capacity to maintain stability of physiological systems in the face 
of adversity.17 When exposed to chronic stressors, such as care for a child with ASD, individuals 
expend a great deal of energy attempting to maintain allostasis; this can lead to the metabolic 
wear and tear described as allostatic load. Evidence is accumulating that this wear and tear is 
mediated by changes in basal stress system activity and by effects of these changes on dependent 
systems.18 Allostatic load and resilience can therefore be assessed by measuring basal stress 
system activity (HPA axis and salivary alpha-amylase). 
Thus, research to reduce these parents’ exposure to stress and, moreover, improve 
parental responses to stress, may improve the wellbeing of both parents and their children. Yet, a 
treatment focused on the psychosocial needs in relation to stress and allostatic load of parents of 
children with ASD has not been developed. Research is warranted to examine and intervene 
upon parental stress. This study aims to design and develop a resiliency intervention to provide 
support to parents of children with ASD.  

2 
This intervention will be a modified version of Dr. Park’s evidence-based 8-week 
multimodal treatment which is designed to promote adaptation to stress and promotion of 
resiliency. The program is an 8 session, 1-1.5 hours a week multi modal intervention that 
incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for 
coping with stress. This study will refine an 8-session group virtual-delivered resiliency 
treatment program consisting of 8 virtual group 1-1.5 hour sessions. The goal of this study would 
be to advance our ultimate objective to implement a national parental resiliency program. 
II. SPECIFIC AIMS
The proposed research has the following objectives: 
Specific Aim 1 (Phase II): Informed by Phase I findings, (approved in a previous IRB protocol 
#2016P001698), we aim to develop and determine the feasibility (by assessing the number of 
sessions attended and adherence to Relaxation Response practice) and acceptability (assessed 
using the Participant Feedback Survey) of an 8-session Relaxation Response Resiliency 
(SMART-3RP) program for parents of children with ASD.  
Hypothesis: The SMART-3RP virtual delivery will be feasible to implement and acceptable to 
parents of children with ASD.  
Primary Aim 2 (Phase III): To test the effectiveness of a pilot waitlist controlled trial on 
improving resiliency, as measured using the General Self-Efficacy Questionnaire, Current 
Experiences Scale, and the Visual Analogue 0-10 scales (including stress, distress, coping, and 
physical discomfort), and on improving stress reactivity (as measured by the Measure of Current 
Status-A), growth enhancement (as measured by the Cognitive and Affective Mindfulness Scale-
Revised), and parental stress (as measured by the Parental Stress Scale).   
Primary Hypothesis: Patients randomized to the Immediate group will report significantly 
greater scores on the primary outcomes (measures of resilience) and on the secondary outcomes 
(measures of stress reactivity, growth enhancement, and parental stress) at 3 mo. post enrollment.  
Secondary Aims: Among participants randomized to both conditions, to investigate the extent 
of pre-post changes in primary and secondary outcomes (Immediate: assessments from baseline-
3 mo.; Waitlist: from 3-6 mo.).  
Secondary Hypothesis: Scores on primary and secondary outcome measures will improve from 
pre-post intervention.   
Secondary Aim 2: Among immediate condition group only, to assess whether end-of-treatment 
(3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment. 
Hypothesis: These end-of-treatment effects will show sustained improvement on primary and 
secondary outcome measures from 3 to 6-mo. Post enrollment.   
Secondary Aim 3: To pilot test the end-of-treatment effects of the SMART-3RP on parents’ 
stress levels using hair cortisol. A mixed effects models approach will be used to examine group 

3 
differences in hair cortisol concentrations (HCC) at baseline and 3 mo. post enrollment. Pearson 
correlation or Spearman’s rank correlation will be used to examine the association of HCC with 
each of our psychological outcomes. 
Hypothesis: Parents randomized to the Immediate group will show improvements in biomarkers 
of stress system function, in particular the hypothalamus pituitary adrenal (HPA) axis and 
sympathetic nervous system (SNS) relative to baseline. It is expected that stress-related 
alterations will be found in parents before the intervention and will improve in those individuals 
that respond favorably to the treatment. Biomarkers will thus allow an additional level of testing 
for chronic stress, and efficiency of the intervention; measuring basal HPA axis and SNS activity 
further allows us to draw conclusions about the adverse long-term health effects of chronic stress 
and to evaluate the efficiency of the intervention in ameliorating such biological changes.  
III. SUBJECT SELECTION
We will recruit through our contacts in the community including other MGH clinicians, as well 
as through local and national support groups and list serves using IRB approved recruitment 
materials. MGH child psychologists may also refer potentially eligible participants. Interested 
participants may call or email the study staff to learn more about the study.   
The current study will employ a pretest-posttest, pilot waitlist controlled design to test the 3RP 
for parents of children with ASD. Participants will be recruited from local, national, and 
international organizations, school systems, and hospital clinics.  
Inclusion/Exclusion Criteria 
Inclusion criteria are: 
1) Being the parent of at least one child with an autism spectrum disorder
2) Age 18 or older
3) Can read and speak English
One or more of the following exclusion criteria will render an individual ineligible: 
1) Unable or unwilling to sign the informed consent documents
2) Regular use of corticosteroids at the discretion of the Principal Investigator
3) Unable or unwilling to participate in an intervention delivered via videoconferencing.
Recruitment 
A total of approximately 70 participants will be recruited for this study. Both males and females 
from diverse racial and ethnic backgrounds will be recruited using IRB approved procedures. 
Potential participants will be recruited from our contacts in the community including other MGH 
clinicians, as well as through local and national support groups and list serves using IRB 
approved recruitment materials. MGH child psychologists may also refer potentially eligible 
participants. In each case, interested participants will be directed to our pre-screen REDCap 
survey and will be given the option to contact the study staff to learn more about the study.  
IV. SUBJECT ENROLLMENT

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Methods of enrollment 
Participants will contact the PI or study staff by telephone, email, or by completing our IRB 
approved pre-screen REDCap survey in response to advertisements.  Subject will be contacted 
by phone, informed about the study and given an pre-screen REDCap to determine whether they 
meet inclusion/exclusion criteria (see the attached pre-screening questionnaire). Subjects may 
also be referred to the study. Subjects must respond “yes” to all inclusion criteria and “no” to all 
exclusion criteria to be eligible for the study. Eligible participants will be consented and will 
complete the baseline survey online into REDCap, a secure, web-based application designed to 
support data capture for research studies.   
Randomization 
After enrollment, participants will be randomized to the Immediate intervention group (IG) or 
Waitlist control group (WG). Randomization will be conducted using a random plan generator, 
with 1:1 randomization. The WG will begin their program approximately 3 months after the 
SMART-3RP group. For both groups, the intervention will last approximately 8 weeks, weekly 
with groups meeting once per week for approximately 1-1.5 hours. 
Informed consent process 
Eligible and interested participants will be sent a consent form and scheduled for a phone 
consent.  Informed consent and authorization will be obtained and documented through use of a 
written consent form approved by the Partners Human Research Committee (PHRC) and signed 
by the participant. The PI or qualified study staff will complete informed consent procedures.  
Participants will be asked to read the consent form fully on their own before discussing the 
consent form with a study staff member (either on the phone or using videoconferencing). The 
participant will have the opportunity to ask any and all questions about the study. Once all 
questions have been addressed, they will sign the consent form and send it to the study staff 
member (either via email, scan, fax, or mail). The study staff member will then sign the 
participant’s signed copy and send a copy back to the participant for their records. As informed 
consent is a continuous process, participants will be invited to ask questions about their 
participation at any point over the course of the study.  
The consent form will include a description of all study procedures, information about potential 
risks and benefits of participation, and study contact information (including that of the IRB) in 
case questions arise at a later time. The consent form will also explicitly state that study 
participation is voluntary, and that participants may refuse to answer any questions that make 
them uncomfortable, and may discontinue participation at any time. The consent will also 
explicitly state that this intervention is psycho-educational and is not clinical care.  
In addition, special attention will be given during the consent process to the implications of 
receiving an intervention online via a videoconferencing platform. Subjects will be explicitly 
informed 
that 
the 
video 
conferencing 
services 
provide 
secure 
HIPAA-compliant 
videoconferencing software. We will explain to participants that although we will do our best to 
ensure confidentiality on our end, we cannot guarantee 100% that other group members will not 

5 
share the content of the group. Participants will also be advised to wear headphones and sit in a 
quiet place to protect their own, and other group members’ privacy.  
V. STUDY PROCEDURES
Program development 
The Phase I (described previously in protocol #2016P001698) findings will be used to guide the 
development of a resiliency program targeted to the needs of parents of children with ASD.  
Study staff will administer the consent form with participants either on phone or using the 
videoconferencing system. To facilitate proficiency with the software, participants will test the 
software with a study staff member either during consent or on a brief test call prior to the start 
of the intervention.  
Assessments 
Study assessments include a battery of questionnaires via REDCap and two hair cortisol sample 
collections. At baseline, participants will be administered baseline questionnaires and asked to 
provide a hair cortisol sample. At 3 months post enrollment, participants are administered a 
second set of questionnaires and asked to complete a second hair cortisol sample. At 6 months 
post enrollment, participants are administered their final set of questionnaires. 
Hair Cortisol 
At enrollment (baseline) and at 3 months post enrollment, all participants will be asked to 
provide a hair sample to measure potential changes in cortisol levels, a method used successfully 
in stress studies. Participants will be asked to cut a small amount of hair (approximately 150 
strands, which is about the diameter of a small paperclip) as close to the scalp as possible (about 
3 cm), and from the back of their head. They will be asked to band or tie the strands near the 
scalp end, place on the sample in aluminum foil, and return in an envelope to MGH. Participants 
will be sent detailed sampling instructions and stamped, addressed envelopes to facilitate 
mailing.  We are asking participants about their use of corticosteroids because they may interfere 
with hair cortisol samples.  
The assessments are itemized below. In addition, participants will be asked to complete practice 
notes throughout their intervention.  
Administered at Baseline: 
3RP Battery of questionnaires 
Hair Cortisol Samples 
Administered 3 months post enrollment: 
3RP Battery of questionnaires 
Hair Cortisol Samples 
Participant Feedback Questionnaire 
Administered during Intervention (either starting after baseline or 3 months post enrollment) 

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Progress Note 
Administered 6 months post enrollment 
3RP Battery of questionnaires 
Participant Feedback Questionnaire 
Intervention 
In the SMART-3RP intervention, sessions focus on developing an understanding of stress 
physiology and the physiology of the relaxation response (RR), on developing a regular practice 
of eliciting the RR, and on learning cognitive behavioral and positive psychology/resilience 
skills. In addition to the weekly group sessions, participants will receive audio recorded guided 
meditations for independent relaxation practice. Participants are expected to practice eliciting the 
RR for approximately 20 minutes a day throughout the course of the study, using the audio 
recording provided and/or any other meditative or mind body techniques. Participants will 
complete a daily log reporting how often and by which methods they are practicing the RR. 
(Please see attached practice log).  
The SMART-3RP will be delivered virtually, via the Partner’s secure videoconferencing 
platform. The intervention will not be delivered clinically, and will be a psycho-educational 
intervention. Participants will be asked to wear headphones and sit in a quiet room by themselves 
for each of the sessions.  
What does it involve? 
The SMART-3RP involves participating in eight, 1-1.5 hour sessions, once a week via 
videconferencing. The SMART-3RP is a manualized psychoeducational program and each 
participant will be sent a manual to use during each session and to practice exercises each week. 
In each session, participants will learn a new type of relaxation response method, such as 
meditation or seated yoga. Participants will also learn more about stress and its effects on the 
body and mind. The program will discuss strategies and techniques to help participants manage 
daily stressors, through the use of breathing techniques, and cognitive reappraisal. We will also 
discuss adaptive strategies, such as incorporating more positive activities into participant’s lives 
to add enjoyment and time for self care. 
Groups consist of no more than 8 participants, and can be smaller as well. The group consists of 
participants, parents of children with ASD, as well as a group leader and a study staff member. 
The study staff member is fully trained in observing SMART-3RP groups, and will be setting up 
the videoconferencing group each week, and helping participants connect to the group. 
At the start of the program, the leader clearly discusses the importance of confidentiality and 
asks that participants sit in a room alone, not record the sessions, and not share any other group 
members’ personal information with others outside of the group. The program also discusses 
goal setting to help partcipants identify some personal goals and strategize ways to begin 
tackling them. These goals are addressed through weekly practice. 

7 
Homework and exercises 
Homework each week involves practicing the skills discussed in the previous session. 
Participants are encouraged to listen to the audio recordings of meditation exercises that come 
with the program manual. In each session, participants are encouraged to discuss their thoughts 
about their practice, what they liked, and what they did not like. No one is required to do any 
practice that they do not find helpful. We collect copies of the practice logs. 
The practice logs include: 
a) Types of RR exercises practiced and duration of practice
b) Appreciations: participants are asked to list three things they appreciated each day of the
week—this exercise helps bring awareness to the positive aspects of our lives, and allows 
us to re-live enjoyable moments through remembering them 
c) SMART goals—participants are encouraged to write down specific small goals for the
week such as, “take a walk outside at least twice”—to help them moved towards their 
larger goals 
Other exercises that we practice in the SMART-3RP include exercises that help participants 
identify specific stressors, how they feel when they experience stress, what types of thoughts 
they have, and what it is about the particular incident that makes them feel stressed. We do a 
practice exercise as a group and encourage participants to practice for homework by thinking 
about their thoughts and feelings when they get stressed. They are also encouraged to complete a 
coping log if they are interested. They do not turn this into us as it is just for their own benefit. 
An adaptive exerciuse we practice involves using humor as a coping mechanism. We read 
examples of using humor to cope with a stressful situation. We also encourage participants to 
complete an exercise (they do NOT have to share) in which they use humor to describe a 
personal incident that was stressful in the moment. We discuss the differences between sarcasm 
and humor and how humor is adaptive, but sarcasm is not. 
SMART-3RP outline of each session: 
Session 1 
Overview 
The goal of this session is to start to examine your personal stressors, and what resources you 
have to cope with stress. We start the session with an overview of the science of the stress 
response and the relaxation response, and the concept of resiliency. We examine the overall 
process involved in building resiliency and its three essential elements. 
Session Content 
The Science of Mind-Body Medicine 
•
The stress response
•
The relaxation response
Components of the SMART program 

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• Practicing RR techniques 
•
Stress awareness
•
Adaptive strategies
Breath Awareness 
The weekly Practice Note 
Tips for Developing a Consistent Practice 
In-Session Exercises 
Body awareness 
RR Practice: Single-pointed focus meditation 
RR Practice: Simple Breath awareness 
Energy battery 
Between-Session Practice 
Complete the Practice Note 
•
RR practice: simple breath awareness
•
Daily appreciations
•
Lifestyle behavior and social connectedness goals
•
Symptoms check-in
Session 2 
Overview 
In this session we explore different ways to bring about the RR and develop the concept of 
“mini” RR exercises. We deepen our understanding of the RR by practicing body awareness, and 
troubleshoot common problems in practicing the RR. We further explore the tendency to focus 
on negative emotions and physical sensations. We discuss how diminished sleep can be made 
worse by or promote stress and, conversely, how recuperative sleep can promote resiliency. 
Session Content 
Recuperative sleep 
•
Sleep tips
•
The sleep diary

9 
The Mini 
In-Session Exercises 
RR Practice: Body scan 
Assessing your sleep 
Identifying emotions and positive physical sensations 
RR: Minis 
New Between-Session Practice Items 
Biodot awareness exercise 
Sleep diary 
Session 3 
Overview 
In this session, we continue to explore different ways to decrease stress reactivity, and we 
introduce the concept of mindfulness. We also develop awareness of stress-linked thoughts, 
emotions, behaviors, and physical experience, and introduce the concept of social support. We 
discuss the different types of social support, and we examine which types of social support you 
have, give, and utilize. 
Session Content 
Mindful Awareness 
Social Support 
In-Session Exercises 
RR Practice: Mindful Awareness Meditations 
Mindful Eating 
Stress Warning Signals 
The Social Support Diagram 
Mini of the Week: Mindful Body Awareness 
New Between-Session Practice Items 

 
10 
 
New and Good 
 
Mindful Awareness in Daily Living 
 
Mini of the Week: Mindful Body Awareness 
 
Session 4 
Overview 
In this session we examine how stress affects both the mind and the body. We begin this session 
by introducing a body-based RR technique: yoga. Then, we introduce the concepts of negative 
automatic thoughts and thought distortions and focus on adaptive strategies to cope with stress. 
 
Session Content 
 
Awareness of Movement  
• Awareness of Movement in Daily Living 
 
Negative Automatic Thoughts 
 
Thought Distortions 
 
In-Session Exercises  
 
RR Practice: Yoga 
 
Mini of the Week: Walking Meditation 
 
New Between-Session Practice Items 
 
Coping Log, Part 1 
 
List of Pleasant Behaviors 
 
 
Session 5 
Overview 
In this session we introduce guided imagery, which utilizes the imagination to evoke a sense of 
well-being and encourage insight. We continue to raise awareness of negative thoughts and 
introduce how to change negative perspectives to adaptive ones. We encourage ongoing 
reflection in order to create meaning from daily events that would otherwise have gone 
unnoticed. We discuss the value of purposeful engagement in pleasant behaviors and provide tips 
to remember to eat mindfully. 
 
 
Session Content 

 
11 
 
 
Creating an Adaptive Perspective 
 
Healthy Eating   
 
 
In-Session Exercises  
 
RR Practice: Insight imagery 
 
Coping Log, Part 2 
 
Achieving Acceptance 
 
Mini of the Week: Joyful Place Imagery  
 
New Between-Session Practice Items 
 
Stop, Breathe, Reflect, Choose 
 
Food Pyramid 
 
Session 6 
Overview 
We begin with a meditation that emphasizes the cultivation of positive, adaptive qualities such as 
kindness and love. Next, we expand our discussion of adaptive perspectives by exploring how 
expressing ourselves optimistically and pessimistically can influence resiliency and stress. We 
then look at the underlying fears that lead to pessimistic thinking. We address the importance of 
physical activity to stress reduction and health. Finally, we reflect on the experience of being in 
the RR to date, and how it contrasts with the experience of being in the stress response.  
 
Session Content 
Promoting Physical Activity  
 
In-Session Exercises 
 
RR Practice: Contemplation 
 
Comparing Optimism and Pessimism 
 
Relaxation Signals 
 
Good, Bad, Routine 
 
Mini of the Week: Contemplation  
 
 

 
12 
 
New Between-Session Practice Items 
 
From Pessimism to Optimism 
 
 
Session 7 
Overview 
In this session we explore the practice of problem solving and acceptance as adaptive responses 
to stressful situations. We will examine the fears that may underlie our negative thinking. We 
will discuss the importance of creativity and will use poetry to demonstrate how creative 
expression and insight support adaptive responses. 
 
Session Content 
 
Coping Strategy: Problem-Solving vs. Acceptance 
 
Creative Expression 
 
Empathy 
 
In-Session Exercises 
 
RR Practice: Loving Kindness 
 
Root Fear 
 
Poetry 
 
Empathy/Mindful Awareness of Another 
 
Mini of the Week: I am… at peace 
 
New Between-Session Practice Items 
 
Practice Creativity 
Letter to Self 
 
Session 8 
Overview 
In this session, we learn how to use humor and imagination to enhance adaptive coping. We 
review the program content and reflect upon what participants have learned, what has been 
particularly helpful for them, and how they can achieve their “idealized selves,” reminding them 
that imagery of idealized self is helpful. We end with an important skill- using humor to enhance 
resiliency. We revisit the Energy Battery that we competed in our first session, and reflect on our 
current battery. We reinforce their use of setting goals in support of maintaining resiliency. 
 

 
13 
 
Session Content 
 
Humor and Coping 
• Laughter 
• More Humor Strategies 
 
Staying Resilient 
• Tips for Staying Resilient 
 
In-Session Exercises 
 
RR Practice: Idealized Self 
 
Energy Battery, Take 2 
 
Finding Humor in Your Life 
 
Laughter 
 
Mini of the Week: Tonglen 
 
Program Review 
 
Review of RR Practice Note 
Review of stress and Coping Logs 
Review first session energy battery 
 
 
 
SMART-3RP Development 
 
The process of developing the Benson-Henry Institute’s SMART-3RP is further described in Dr. 
Elyse Park’s article, The Development of a Patient-Centered Program Based on the Relaxation 
Response: The Relaxation Response Resiliency Program (3RP). The current program that will be 
used in this study is an adapted version of the original program, and is tailored to the needs of 
parents of children with ASD.  
 
Differences in the adapted program include: 
-Examples in each exercise tailored to parents 
-An introduction at the beginning of the program about parental stress, and how we hope to 
provide useful stress management skills to help parents of children with ASD. 
-A list of recommended resources for parents if they are interested (list serves etc) 
 
Participants randomized to Immediate or Waitlist will participate in the SMART-3RP program. 
Participants in the Immediate arm will be encouraged to practice the skills taught in the program 

 
14 
 
during the 3 month follow up period after completion of the 8 session SMART-3RP. Participants 
in the Waitlist arm will wait for approximately 3 months before beginning the SMART-3RP.  
 
Participants in both groups will be given questionnaires at the same timepoints (baseline, 3 
month post enrollment, and 6 month post enrollment). Study staff will email these questionnaires 
to the participants via the REDCap system. Participants who have not responded within two 
weeks of each time point will be contacted by telephone to ensure receipt of study data. 
 
 
Figure 1 (below) illustrates the administration of questionnaires in both groups.  
 
Figure 1. Study Design. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Remuneration 
Participants will be given a $20 gift certificate for completing 3 mo. survey and another $20 gift 
certificate for completing the 6 mo. survey assessment. 
 
Participants may also be compensated up to $40 for their hair samples ($20 for the first and $20 
for the second). Compensation will be provided for those who have already submitted at least 
their baseline hair sample, and for all future participants interested in completing their hair 
samples. 
 
VI. BIOSTATISTIC ANALYSIS 
 
 
3 mo. Post 
Enrollment 
 
T2 
6 mo. Post 
Enrollment 
 
T3  
Baseline 
 
T1 
Waitlist Control 
(WG)  
 
(No treatment) 
Administer pre-
screen 
questionnaire 
Conduct phone 
consent 
Baseline Assessment 
(3RP Battery of 
psychological 
measures) 
Immediate Group 
(IG)  
Starts SMART-
3RP (8 sessions via 
videoconferencing 
software) 
3 mo. Post 
enrollment 
assessments 
(psychological 
measures) 
3 mo. post 
enrollment 
(psychological 
measures), n=35  
 
Starts (SMART-
3RP  
8 sessions via 
videoconferencing) 
6 month post-
enrollment 
assessments  
(3RP Battery)  
End-of-treatment 
assessments (3RP 
Battery) 

 
15 
 
We plan to conduct a pilot trial of a virtual-based SMART-3RP intervention for parents of 
children with ASD. Participants in this trial will be randomized to one of two groups: 1) 
Immediate SMART-3RP intervention, or 2) Waitlist control SMART-3RP group (starting 
approximately 3 months after enrollment). 
 
The following questions will be assessed: 
 
1) Is the virtual SMART-3RP feasible and acceptable for parents who have children with 
ASD? 
 
Feasibility will be assessed using attendance and homework completion (i.e. 6/8 sessions and 
homework completion-See practice note).  
Acceptability will be assessed using a Participant Feedback questionnaire (See Feedback 
questionnaire attached).  
 
2) Is the virtual SMART-3RP program effective for parents of children with ASD? 
 
a) Is there a significant difference in primary and secondary outcome measures 
between participants in the Immediate and Waitlist SMART-3RP groups at 3 mo. 
post enrollment? 
 
We will use paired samples t-tests to compare within group differences on primary and 
secondary outcome measures from 3 mo. to baseline for the Immediate and Waitlist 
Groups.  Primary outcome measures are the General Self-Efficacy Questionnaire (GSE), 
Current Experiences Scale (CES; from the Post Traumatic Growth Inventory), and the 
Visual Analogue 0-10 scales (VAS; measuring stress, distress, coping, and physical 
discomfort). Secondary outcome measures are: the Measure of Current Status-A (MOCS-
A; to assess stress reactivity), Cognitive and Affective Mindfulness Scale-Revised 
(CAMS-R; to assess growth enhancement), and the Parental Stress Scale (PSS; to assess 
parental stress). 
 
We will then use independent samples t-tests to compare the difference between the 
Immediate group’s 3 months post enrollment and baseline assessment results with the 
difference between the waitlist group’s 3 months and baseline assessment results on 
primary and secondary outcome measures. 
 
b) Among participants randomized to both conditions, will there be improvements 
in primary and secondary outcome measures from pre-post SMART-3RP (IG: 
assessments from baseline-3 mo.; WG: from 3-6 mo.)? 
 
We will use paired samples t-tests to compare all primary and secondary assessments 
from pre-post SMART-3RP (for the IG, assessments are from baseline-3 mo.; for the 
WG, assessments are 3 mo. to 6 mo.).  
 

 
16 
 
c)  Among the Immediate group only, will the changes from baseline to 3 months 
post enrollment (end of treatment) be sustained at 6 months post enrollment (3 
months post treatment)?  
 
We will use paired samples t-test to assess within-group differences in long-term 
outcomes. We will compare measures at the 6 months assessment to measures at the 3 
months assessment for the Immediate group.  
 
 
3) Will the virtual delivery SMART-3RP be effective in reducing participants’ stress levels, 
measured by hair cortisol? 
 
A mixed effects models approach will be used to examine differences in hair cortisol 
concentrations (HCC) at baseline (at enrollment) and 3 months (end-of-treatment) for each study 
arm. Pearson correlation or Spearman’s rank correlation will be used to examine the association 
of HCC with each of our psychological outcomes. 
 
VII. RISKS AND DISCOMFORTS 
 
Participants may feel uncomfortable completing various psychosocial questionnaires. As in any 
research study, there is a small risk that confidentiality may be breached; all efforts to minimize 
this risk will be taken, as outlined below. In addition, participants may find it time consuming to 
practice techniques learned in the intervention or tracking behavior such as elicitation the 
relaxation response. 
 
Hair cortisol collection: some participants may feel uncomfortable sending us a hair sample. If 
they feel this way, they will not need to. Participants can still remain in the study if they do not 
wish to send a hair cortisol sample.  
 
VIII. POTENTIAL BENEFITS 
 
Participants in the current study may observe a reduction in symptoms of parental stress. It is 
hoped that the intervention will result in a statistically and clinically significant reduction of 
symptoms across these domains.  
 
The current study may provide support for parents of children with ASD. This intervention may 
enhance our understanding of the role of mind-body interventions such as the SMART-3RP in 
parents of children with ASD. This intervention may have widespread implications for types of 
resources available that may ultimately improve health and well being of parents and children 
with ASD.  
 
 
IX. MONITORING AND QUALITY ASSURANCE 
 
All study staff will complete required Partners human subjects trainings prior to the start of study 
procedures. All interventionists and assessors will have advanced training in interviewing and 

 
17 
 
assessment. Participants will be informed that they may refuse to answer questions that make 
them feel uncomfortable. Participants will be advised to wear headphones and sit in a quiet place 
during each virtual session. Participants will also be asked not to share the contents of the group 
with anyone else.  
 
Electronic information will be stored in REDCap (Research Electronic Data Capture), a free, 
secure, and HIPAA-compliant web-based application hosted by the Partners HealthCare 
Research Computing Enterprise Research Infrastructure & Services (ERIS) group (based at the 
PHS Needham corporate datacenter).  
 
REDCap (Research Electronic Data Capture) is a free, secure, HIPAA compliant web-based 
application hosted by the Partners HealthCare Research Computing Enterprise Research 
Infrastructure & Services (ERIS) group. The system offers easy data manipulation with audit 
trails, reports for monitoring and querying participant records, and an automated export 
mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).  
 
Data will be stored on password protected computers that will be stored in secure locations at all 
times. Paper data files (with coded subject identification) will be stored in a locked filing cabinet. 
Only research staff will have access to these data locations.  
 
A unique anonymous identifier will be assigned to each subject; subsequently, all data collected 
will be associated exclusively with this identifier. This includes all questionnaires administered 
over the course of the study, as well as home practice logs. 
 
 
Data Management and Quality Control Procedures 
 
To maximize accuracy and security, all survey data will be collected and stored on REDCap. 
Research staff will ensure that proper consent has been obtained before sending the REDCap 
survey to each participant.  
 
Data and Safety Monitoring Plan 
 
Adverse Event Monitoring: Throughout the study subjects will be monitored for the occurrence 
of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment 
is not considered an event. All adverse events will be reported on an adverse event form.  
 
The principal investigator is ultimately responsible for data and safety monitoring. If study staff 
becomes aware of any adverse events, the event will be reported immediately to the Principal 
Investigator. The Principal Investigator has the responsibility of reporting serious adverse events 
(death, life threatening illness or injury, serious injury, or permanent disability) to PHRC within 
72 hours of notification. 
 
 
Subject Safety 
 

 
18 
 
In the case that an issue related to mandatory reporting or duty to warn arises, we will contact the 
Office of General Council for advice on how to proceed.  
 
 
 
X. REFERENCES 
 
 
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18 Adam, EK & Kumari, M. (2009). Assessing salivary cortisol in large-scale, epidemiological research. 
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