Comparative Efficacy of a Self-directed and Therapist-assisted Telehealth Parent Training Intervention for Children With ASD
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Michigan State University

 
 
 
 
 
 
 
 
Protocol for Comparative Efficacy of Self-directed & Therapist-assisted Telehealth Parent 
Training Intervention for Children With ASD 
 
NCT02721381 
 
Based on last approval by MSU IRB on 4/6/2020 
 

Risk to Human Subjects 
a. Human Subjects Involvement, Characteristics, and Design 
A total sample of 90 children with ASD between the ages 18-96 months and their primary 
caregivers will be recruited for this study. This sample size was determined to be adequate for 
maintaining adequate power for the proposed statistical analyses, while allowing for some 
attrition.   
Inclusion Criteria for Families: To be eligible for participation, 1) the child must receive a 
DSM-V-informed clinical diagnosis of Autism Spectrum Disorder, based on the Autism 
Diagnostic Observation Schedule (ADOS). The diagnosis may be provisional for children under 
age 3 (typically listed as "at risk for ASD"). Children with this classification will be included as 
well. (2) The child must fall between the ages of 18 - 96 months at enrollment into the study, 
which will allow for data collection during the period of early intervention and early childhood 
special education programming. (3) The parent must understand spoken English as the training 
materials are presented in English. 
Exclusion Criteria for Families: (1) Children with ASD who have a history of significant brain 
injury or known neurological condition in addition to a diagnosis of ASD, significant sensory 
impairment or major medical problems. These children and their families may require very 
specific adaptations to the treatment and thus the results will not be representative of children 
with ASD. This will be determined through review of medical records, diagnostic reports and 
parent interview. Criteria and data sources for identifying participants are outlined below. 
Assignment to Study Group:  Participating children and their primary caregivers will be 
assigned to one of three groups. Participants will be stratified by age (18-35 months; >36 
months) and developmental quotient (DQ<55; DQ ≥55) at project enrollment, prior to being 
randomized. After stratification, participants will be randomly assigned to the one of the three 
groups using random permuted blocks of 6. This approach has been shown to yield groups that 
are closely balanced with regard to size and relevant pre-treatment characteristics. All pre-
treatment assessments will be collected prior to randomization to prevent bias during testing 
based on knowledge of future group placement.   
b. Sources of Materials 
The sources of data for this study will include: (1) direct assessment of child functioning 
using standardized assessments; (2) completion of standardized questionnaires by parents; (3) 
written survey completion by parents; and (4) videotaped coding of treatment processes.  All 
data will be used exclusively for research purposes. All surveys and interviews will use codes 
rather than subject names. Only the PI and primary research team members will have access to 
subject identities. Procedures to minimize risk of loss of confidentiality are presented below. 
Child Measures: Child diagnostic testing will be conducted at pre-treatment. We will also 
examine specific child characteristics (cognitive ability level, language level, autism severity) 
that are predicted to be related to the impact of the parent-implemented interventions. We will 
administer the Autism Diagnostic Observation Scale, 2nd Edition (ADOS-2) to the child at pre-
treatment. The ADOS-2 is a standardized protocol for observation of social and communicative 
behavior associated with a diagnosis of ASD that has been shown to have high reliability and 
discriminant validity. Recent longitudinal studies have demonstrated that diagnostic stability for 
children under age 3 is best when using DSM-IV based clinical judgment in conjunction with 
results from standardized diagnostic instruments, such as the ADOS.  As in previous studies, 
this is the approach that will be used in the present study in order to determine a specific DSM-
V diagnosis for each child. The PI has established research reliability on the ADOS. She will 
train the clinical research staff on these methods (as needed) and supervise all assessments. 
Child cognitive ability will be assessed using the Mullen Scales of Early Learning at T1.  Child 
intentional communication with the parent will be scored from a parent-child interaction in the 
home at pre-treatment and post-treatment using weighted frequency of intentional 
communication.  Language outcomes will be assessed at pre-treatment and follow-up using the 

Mullen Scales of Early Learning, a parent report measure (the MacArthur-Bates Communicative 
Development Inventory) and the Vineland Adaptive Behavior Scales.   
Parent Measures:  Parents will complete the Parenting Sense of Competence Scale at pre-
treatment, post-treatment, and follow-up to assess parent self-efficacy.   Using the videotapes of 
the parent-child interaction in the home at pre-, post-treatment, and follow-up, the research 
team will assess parent use of the intervention strategies.  Parents will also be asked to provide 
demographic information and complete the Parent Expectancies for Therapy Scale, a measure 
of treatment expectancy, the Computer-Email-Web Fluency Scale, a measure of 
computer/internet fluency, at pre-treatment, and the Parenting Stress Index, a measure of 
parenting stress at pre-treatment.  Parents will be asked to complete the Treatment Evaluation 
Inventory, measure of treatment acceptability, at the conclusion of treatment.  Parents will 
complete the Additional Services Form to monitor the type and number of hours per week of all 
non-study treatments once per month throughout study participation.  
c. Potential Risks 
There are no known serious health or psychological risks related to participation in this 
study. Procedures to minimize risk of loss of confidentiality are presented in the following 
section. In addition, there are legal limits to the confidentiality of information obtained during the 
research study. All information obtained from participants will be held confidential unless there is 
serious threat of harm to a child or to self or others. These limitations will be addressed in the 
consent forms. Collection of data from participants will include standardized child assessment 
measures, standard parent questionnaires regarding their child's development and behavior, 
standard parent questionnaires about their well-being and satisfaction with treatment, and 
videotape recordings. Precautions will be applied to all collected data from these activities, 
which will be stored in a private, secure and confidential location at MSU. All participants will be 
made aware of how collected data will be handled. 
 
Adequacy of Protection Against Risks 
a. Recruitment and Informed Consent 
Primary caregivers of children with ASD will be recruited to participate in this study.   
Recruitment will be conducted through our ongoing contacts in Intermediate School District 
preschool special education programs and with clinicians at a number of sites in Lower 
Michigan. If a child appears to be eligible for the study, the clinician at that site will introduce the 
study to the family and present them with a brochure about the research project. In addition, a 
description of the study will be placed on the P.I.’s website which the public can access. 
Families who wish to participate will contact the project manager directly.  The project manager 
will contact families to further explain the study, answer questions and schedule the first 
assessment session. The project manager will schedule an initial interview with the parents. At 
the beginning of that interview, the consent documents will be reviewed and written consent will 
be obtained from the parent. No child assent will be obtained because all children are expected 
to have significant cognitive and language delays that would prevent them from giving informed 
assent. Potential participants will be informed about the purpose and nature of the study and 
their rights as a participant. Written consent will be secured prior to the initiation of study 
participation. Participants will be assured of the maintenance of confidentiality and informed of 
their right to refuse to provide any data. Participants will be assured that data will only be 
reported in aggregate form without any individual identifying information. Parents will be 
compensated with $25 for the pre-treatment, post-treatment, and follow-up assessment, totaling 
$75.  Each assessment period will consist of three to four hours of testing, involving direct child 
assessment, parent interview, and on-line data collection which may be completed across one 
to two visits. Applications for informed consent will be submitted to MSU’s Human Research 
Protections Program. The nature of the proposed Research Plan is very similar to approved 

studies currently being conducted by the P.I. As required, all amendments will be submitted for 
approval before being implemented. Annual project renewals will be submitted as required. 
b. Protection Against Risks 
1. Protection of Confidentiality:  The current research proposes to collect both (a) 
personally identifying data (e.g., name, birth date, ethnicity, etc.) and (b) research data (e.g., 
interviews, diagnostic data, clinical assessment data, etc.). When connected only to a numeric 
identifier, the majority of the research data does not contain information that could identify a 
participant. When possible, standard protocols containing a numeric research identifier will be 
employed to separate personally identifying information from the research data. Video files will 
be coded with only the unique numeric identifier. The PI has had substantial experience 
ensuring the safety and confidentiality of video data. Personally identifying information will be 
stored in a single database that is located in the PI’s lab. This database will be encrypted and 
have an access password that is only known to the PI and appropriate research members. 
Research data collected will be coded with a participant’s unique identifier, or number and 
personally identifying data will not appear on any research data. All individuals working on the 
study will sign confidentiality agreements to never disclose any individual information regarding 
any aspect of the study. All data will only be reported in aggregate form without any identifying 
information.  
2. Legal Limits of Confidentiality:  There are legal limits to the confidentiality of 
information obtained in the data collection process. As a Licensed Psychologist, Dr. Ingersoll is 
a mandated reporter of child maltreatment risk. Specifically, if direct evidence of child 
maltreatment is reported in a research interview and/or observed in one of the videotaped 
parent training sessions, the researcher will communicate any such concerns to the PI and it 
may be reported to Child Protective Services. The PI will evaluate any possible reportable 
content or event and will make the report, if she deems there to be significant risk to a child’s 
safety and/or health. Similarly if there is direct evidence of imminent suicide, partner violence, or 
homicide risk expressed by a parent in a research interview or during training phone calls, 
researchers will be trained to document any concerns related to safety risk and communicate 
these immediately to Dr. Ingersoll who will be on-call at all times. She will evaluate any 
potentially reportable content or event; consult with other experts at MSU, contact authorities as 
warranted, and make immediate follow-up calls to respondents who are acutely distressed. 
Given the characteristics of the subject population, the prevalence of child maltreatment and 
other concerns that require breach of confidentiality (e.g., suicidal risk) is not anticipated to be 
extremely high, but awareness of these issues will be maintained. Participants will be informed 
of these limits of confidentiality in the consent form.  Any adverse events will be reported to the 
MSU Human Research Protections Program and the assigned Program Officer at the relevant 
NIH institute within one week of the occurrence, and summarized in the annual progress 
reports. 
3. Other Risks:  While not an adverse event, general discomfort may occur as participants 
are asked to discuss sensitive information. Efforts will be made to minimize potential discomfort 
associated with participating in any portion of this research. Consent forms will inform parents 
that they may discontinue their child's participation at any point in time. To minimize any 
potential discomfort or inconvenience associated with the research interviews and child 
assessments, such interviews and assessments will be scheduled at the participants’ 
convenience in the family home.  The intervention that will be used with the participants with 
autism is based on well-established principles of Applied Behavior Analysis and developmental 
psychology that have been used with autistic individuals for many years without resulting in any 
physical or emotional harm. Due to the behavioral difficulties exhibited by the target population, 
there is a potential risk of subjects becoming frustrated or bored during the training procedure or 
child assessments. Empirically documented behavioral management techniques will be used to 
address any tantrum behavior in the child participants. These techniques will include redirection 

(i.e., trying to get the child interested in a positive behavior such as playing with a new toy when 
exhibiting negative behavior) and positive reinforcement for positive behavior (e.g., praise, 
access to desired materials). In some cases, extinction (i.e., ignoring the child’s negative 
behavior) will be used if the two previous techniques are not effective. When using extinction, 
the parent will not ignore any self-injurious or dangerous behavior. If the child becomes too 
upset (unable to calm him or herself down within 10 minutes) or if the participant's parent 
becomes upset at his or her child's distress, parents will be encouraged to discontinue training. 
 
Potential Benefits of the Proposed Research to the Subjects and Others 
Parents will be provided with a report of their child’s assessment results at pre-treatment 
and follow-up assessment. These reports will include the results of a comprehensive diagnostic 
evaluation. This report will only be shared with the parents, with our standard caveat that the 
purpose of the evaluation was as part of their participation in a research study and therefore 
should not necessarily be considered the equivalent of a clinical report. In our experience, 
parents usually find these reports to be quite helpful and many choose to share a copy with their 
child's service providers. Parents randomly assigned to the self-directed and therapist-assisted 
telehealth intervention groups will receive an internet-based parent training intervention that will 
be adapted from an evidence-based curriculum.  Parents in the control group will be offered 
access to the self-directed telehealth intervention at completion of the study.  There are no other 
direct anticipated benefits of participation in this study.  There is, however, anticipated benefit of 
the knowledge gained from this study regarding parent-implemented interventions to improve 
outcomes for children with ASD and their families. 
 
Importance of the Knowledge to be Gained 
Knowledge gained from this research study will provide much needed information about 
ability to provide parent training for families with a child with ASD over the internet. Data 
available to date indicates great promise for parent training in terms of improving child outcomes 
and improving the quality of life for parents. Parent-delivered interventions can be implemented 
for relatively modest costs and provide services to a large number of families, in contrast to the 
high costs and limited availability of intensive child-directed services. While these parent-
focused programs are not meant to replace intensive child-directed services for children with 
ASD, they appear to provide complimentary benefits and help to ameliorate the need for autism-
specific services in areas where providers are in short supply.  The provision of parent training 
over the internet has the potential to greatly increase the number of parents who can access 
these services, particularly in underserved areas where access to intervention providers is 
limited.   
 
Statistical Analysis Plan 
 
Overall Approach. The current study will use the Intention-to-Treat model (ITT) in the 
analysis of the primary aims. The ITT approach requires that all participants who are randomly 
assigned be compared on outcomes regardless of their adherence to treatment, reasons for 
withdrawal, or missing responses. Accordingly, we will include all participants in data analysis, 
follow up participants who withdraw from treatment, and impute missing data, as described 
below.   
 
Missing Data.  We will use the Expectation Maximization (EM) algorithm in SPSS to impute 
missing data for analyses that require complete data (e.g., Process Macro). 
 
Preliminary analyses. To determine the comparability of groups on non-treatment variables 
after randomization, group differences will be examined for all T1 pre-treatment and descriptive 
variables. If significant group differences are detected for a given variable, and the variable of 
interest, then the variable will be used as a covariate in subsequent analyses as appropriate. 

We will also examine age and DQ effects and identify whether treatment effects are moderated 
by either.   
Aim 1: To examine the comparative efficacy of self-directed and therapist-assisted 
ImPACT Online on parent outcomes at post-treatment and the 3-month follow-up.  To test 
our primary hypotheses for Aim 1, we will use multilevel modeling with restricted maximum 
likelihood estimation to examine the effect of group assignment on our primary and secondary 
parent outcomes. Time point (pre-treatment, post-treatment, follow-up) will be coded as a 
categorical variable. Change over time across groups will be estimated with the main effect of 
time, and between-group differences in change in outcomes will be estimated with the group by 
time interaction.  
Aim 2: To examine the comparative efficacy of self-directed and therapist-assisted 
ImPACT Online on child outcomes at the 3-month follow-up.  Three measures of verbal 
language will be collected at pre-treatment and follow-up.  If child language measures are 
sufficiently correlated with each other (r>.50), we will create an equally weighted composite 
variable by z-scoring and summing the language measures.  ANCOVA will be used to test for 
mean differences between the three conditions at follow-up.  Pretest values will be included as 
covariates.   
   Aim 3: To examine whether pre-treatment parenting stress moderates the effects 
of ImPACT Online on parent fidelity and parent self-efficacy at post-treatment.  Pre-
treatment parenting stress will be included in the MLM models as a covariate. The pre-treatment 
parenting stress by time interaction will be used to determine whether pre-treatment parenting 
stress moderates change over time, irrespective of treatment group. The three-way interaction 
of pre-treatment parenting stress, group, and time will be used to examine whether the 
relationship between group assignment and change over time (i.e., group slopes) varied by pre-
treatment parenting stress. A significant interaction will be followed up by simple slopes 
analyses. 
Aim 4: To examine whether gains in parent fidelity (or parent self-efficacy) and child 
intentional communication at post-treatment mediate the effects of the ImPACT Online 
on child verbal language at the 3-month follow–up. We will conduct two serial mediation 
analyses using the PROCESS macro in SPSS to examine whether gains in parent fidelity 
(Mediator 1) and child intentional communication (Mediator 2) at post-treatment mediate the 
effect of ImPACT Online in child outcomes at follow-up.  A second serial mediation analysis will 
be conducted to examine whether gains in parent self-efficacy (Mediator 1) and child intentional 
communication (Mediator 2) at post-treatment mediate the effect of ImPACT Online in child 
outcomes at follow-up. 
Aim 5 (exploratory): To identify predictors of parent adherence to ImPACT Online for 
the two treatment groups.   This exploratory aim will be addressed using a multiple regression 
approach in which level of therapist support (self-directed versus therapist assisted) and three 
individual-level factors (computer and internet fluency, expectancies of treatment, and treatment 
acceptability) serve as primary predictors of parent adherence. We will also examine 
sociodemographic variables as predictors as well. 
 
Power Analysis. A series of power analyses were conducted using Borm, Fransen, & 
Lemmens’89 method for estimating sample size for analyses including a covariate. This 
approach takes into account the degree of association between the covariate and the outcome 
(r) by adjusting the required sample size required for an analysis without a covariate by 1 - r2 
and then adding one extra participant per group.  In our case, the covariate is the outcome 
variable as assessed at the pre-test. Analyses predicting parent fidelity (i.e., Aims 1 & 2) 
assumed a T1 to T2 correlation in fidelity of r = .35, and for self-efficacy, the T1 to T2 correlation 
was assumed to be r = .75.  Across the aims involving parent fidelity we found that a sample 
size of 90 participants would provide 80% power to detect moderate to large effects of treatment 
condition (e.g., Cohen’s f = .32).  For parent self-efficacy a sample of 90 would provide 90% 

power to detect moderately sized treatment effects (e.g., f = .25). For the child language 
variables we assumed a correlation between pretest and follow-up of approximately r = .65 for 
each of the three measures. Analyses predicting child language variables at follow-up 
controlling for pretest language scores (i.e., Aims 2 & 4) indicated that a sample size of 90 
participants will have approximately 90% power to detect a moderate effect size (f = .25) for 
treatment condition.