Project ASSIST: Advocating for Supports to Improve Service Transitions
Phase: NA
Conditions: Autism Spectrum Disorder, Autism
Sponsor: Vanderbilt University Medical Center

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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Version Date:  August 10th, 2023 
  
 
 
 
 
 
 
 
Advocating for Supports to Improve Service 
Transitions (ASSIST)  
NCT#: NCT04173663  
PROTOCOL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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Project ASSIST: Advocating for SupportS to 
Improve Service Transitions 
 
 
Julie Lounds Taylor, PhD 
Associate Professor of Pediatrics 
Vanderbilt Kennedy Center Investigator 
Vanderbilt University Medical Center 
PMB 40 – 230 Appleton Pl. 
Nashville, TN 37203 
 
 
 
 
 
 
 
Waisman Center, University of 
Wisconsin Madison 
University of Illinois at Urbana-
Champaign 
Site PI: Leann Smith DaWalt, PhD 
Site PI: Meghan Burke, PhD, BCBA-D 
Senior Scientist 
Associate Professor of Special Education 
1500 Highland Ave 
1310 S. 6th Street 
Waisman Center Room 553 
Room 276F 
Madison, WI 53705 
Champaign, IL 61820 
 
 
 
 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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1. Background 
 
In this background section, we explain the risk factors at play when youth with autism 
spectrum disorder (ASD) transition into adulthood; the problems and societal costs 
associated with this transition; and, the lack of feasible interventions to address this 
challenging period in the life of youth with ASD. With a prevalence rate of one in 59 
(Centers for Disease Control and Prevention, 2018); over 500,000 youth with autism 
spectrum disorder (ASD) exit high school each year (Roux et al., 2015). The years 
immediately after high school exit are a critical time that either makes or breaks a 
successful transition to adulthood. If they don't go well, disengagement from post-
secondary education (PSE), work, and social isolation can persist throughout adulthood, 
leading to significant societal costs. Despite the pressing need to better support youth 
with ASD during this turbulent time, few interventions for these youth have been 
developed and even fewer tested. 
 
The transition to adulthood is a time of significant risk for youth with ASD. Youth with ASD 
almost universally encounter difficult experiences in their educational, vocational and 
social lives. Difficulties become particularly apparent during the transition to adulthood, 
when youth are expected to be gaining independence and actively engaging in young 
adult life. Yet, even the most able individuals with ASD struggle during this time. 
Employment and PSE are difficult to obtain, and are rarely maintained over time. 
Compared to typically-developing youth, youth with ASD are more socially isolated and 
have greater difficulty making friends. Although many youth may struggle during the 
transition to adulthood, youth with ASD are at even greater risk across multiple domains 
of daily life. These risks lead to significant societal costs: when considering both service 
use and lost productivity, lifetime costs for one individual with ASD in the U.S. ranges from 
$1.43 to $2.44 million (Buescher et al., 2014). 
 
The transition years are a critical turning point that set the stage for positive or negative 
trajectories throughout adulthood, and are thus an optimal time for intervention. Although 
autism symptoms and behavior problems tend to improve while youth with ASD are in 
high school, that improvement slows or even stops after high school exit. Daily living skills 
(which improve while youth are in high school) plateau after high school exit, and then 
begin to decline in early adulthood. Social isolation increases during this time. Further, 
our study of 10-year change in vocational activities suggests that the level of 
independence that youth achieve during the years after high school set an upper limit for 
what they will achieve throughout adulthood; although we saw many examples of adults 
who either maintained or declined in their level of independence in vocational activities 
over time, only 5% were upwardly mobile (Taylor & Mailick, 2014). Thus, the transition 
years are a critical time for intervention. 
 
These challenges during transition and beyond are partly caused by problems accessing 
adult services. Because of the Individuals with Disabilities Education Act (IDEA), youth 
with disabilities (including ASD) are eligible for mandated services through the school 
system until the age of 22 years or until they exit high school. However, after high school 
exit, these youth encounter an adult service system that is inadequately funded, 
fragmented, and difficult to navigate. Across the U.S., approximately 2.0 to 2.5 million 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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individuals are currently on waiting lists for adult disability services (National Council on 
Disability, 2005). Even when one is granted eligibility, the system only offers unconnected 
locations for services. Families must contact separate departments for services related to 
employment, home and community, and PSE. Along with identifying, accessing, and 
speaking with various agencies, families must understand each agency's eligibility scheme, 
funding mechanism, and programming. Parents must then advocate in order that the 
program meets the unique needs of their offspring with ASD. As many young adults with 
ASD require assistance in employment and activities of daily living, failure to access these 
needed services leads to serious ramifications. 
 
Moreover, few interventions have been shown effective in smoothly transitioning young 
adults with ASD from secondary school to adulthood. Most programs focus on individual-
based approaches such as teaching social skills or "soft job skills" such as arriving on time, 
being polite, and accepting criticism. Yet, few rigorous studies exist to document 
effectiveness. Similarly, while it undoubtedly helps to increase the capacity of state and 
local adult-disability service systems, political and economic barriers persist. 
 
Proposed Methods and ASSIST Development 
 
Instead of emphasizing the traditional individual or larger system-based approaches, the 
proposed research adopts a complementary approach, focusing on the middle-level of 
parents. We essentially teach parents of youth with ASD to become better advocates. 
Improving parents' ability to advocate on behalf of their son or daughter is a promising 
avenue to improve service access and youth outcomes. Already in most cases, parents 
serve as the main advocates for their offspring with ASD, and close and frequent contacts 
with the adult service system continue throughout adulthood. The mental health field 
increasingly recognizes the importance of focusing on parent needs as parents search for 
services for their children (Hoagwood et al., 2010). In providing supports to families, then, 
mental health workers have shifted from viewing the parent as a patient, to the parent as 
a partner. Parents, too, see family-focused interventions as highly valuable, and such 
interventions can potentially be delivered at low cost, with a high impact. Parent advocacy 
training is one type of family-focused support, and it has the potential to improve service 
access for youth with ASD, as well as improve youth outcomes. Our goal in this project is 
to equip parents with the knowledge, skills, and empowerment necessary to effectively 
access whatever services or resources are available to them. 
 
To train these advocacy skills, we have developed and pilot-tested a parent advocacy 
training, called the Volunteer Advocacy Program-Transition (or VAP-T). The VAP-T aims 
to improve service access and youth outcomes during the transition to adulthood by 
providing parents the knowledge, skills, comfort, and expertise to support their son or 
daughter with ASD in securing a variety of post-high school vocational, community, and 
social activities (supported by R34 MH104428). For this project, we will be tested a 
national adaptation of the VAP-T, which is called ASSIST (Advocating for SupportS to 
Improve Service Transitions).  
 
Drawing from the Vanderbilt Family Empowerment model, we propose a 2-step model for 
how the ASSIST program will improve transition outcomes for youth with ASD (see Figure 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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1 below). Our model holds that advocacy training will increase parents' advocacy 
knowledge, comfort, behaviors, and skills (path a). Such increases will lead to improved 
service access, particularly more effective dealings with service providers, and better 
understandings of service location, workings, access, eligibility, and receipt (path b). 
These increases will also lead to better employment, PSE, social outcomes, and enhanced 
goal attainment for offspring with ASD (path b) - positive transition outcomes may occur 
as a result of improved service access or independent of services (e.g., parents connect 
to informal supports during ASSIST, leading to employment opportunities). 
 
 
 
Our pilot work testing the efficacy of this intervention is promising. Using a randomized-
controlled trial (RCT) design with families of transition-aged youth with ASD, youth whose 
parents took the VAP-T (vs. a wait-list control) were twice as likely to be employed or in 
PSE after high school exit. Youth from the treatment group, on average, had an increase 
of 1.5 services from baseline to 6-month follow-up, compared to a 0.5 service increase in 
the control group (Taylor et al., under review). 
 
Despite its promise, our preliminary work has a number of important limitations that will 
be addressed in the proposed research (see Table 1 below). The pilot work used a small 
sample size of 45 families. This sample was sufficient to demonstrate feasibility and gather 
initial evidence for efficacy, but insufficient to examine moderators of treatment response 
or mechanisms of action. Hypotheses regarding mechanisms can be postulated from our 
pilot work; the proposed project provides the sample size to make more definitive 
statements about why ASSIST participation leads to improved service access and youth 
outcomes, who is most likely to benefit, and what modifications might be made for families 
unable to access or benefit from the content.  
 
 
 
 
 
 
 
 
Next, the program was developed to reflect the availability and eligibility of services in 
one state (Tennessee); this decision was made because the adult service landscape differs 
from state to state. In the proposed project, we revise the curriculum to be nationally-
relevant, by presenting aspects of each topic that are applicable across states and bringing 
in local experts to present information relative to their region. We also improve upon our 
study design by replacing a wait-list control with an active, materials-only control. The 
control group will receive the same written materials as the treatment group, but will not 
Table 1. Limitations of Pilot Work and Solutions 
Limitation 
Proposed Solution 
Small sample 
Sample adequately powered to 
test mediators and moderators 
State-specific 
curriculum 
Nationally-relevant curriculum 
delivered at multiple sites 
Data only collected 
from parents 
Data collected from parents and 
youth with ASD 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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receive the group-based training (they will have the option to participate in the training 
at the end of the study) This design improves upon our pilot work in two ways: (1) it will 
allow us to test whether receiving written information, without training, has similar 
benefits as the group-based program; and (2) it is more acceptable to participants. 
Though participants were not blinded, research staff facilitating completion of the surveys 
were blinded to experimental conditions. 
 
2. Rationale and Specific Aims 
 
An overview of the current study design is presented here (see Figure 2 below). We 
propose a multi-site (Nashville, TN; Chicagoland, IL; Madison/Milwaukee, WI) RCT of 180 
families to test the effectiveness of ASSIST. Participants will be recruited in two cohorts 
and randomly assigned to either a treatment or materials-only control condition.  
 
 
 
By randomly assigning participants to conditions, we reduce the likelihood of confounders 
that obscure treatment effects. Recruiting across three sites with diversity in community 
size, racial/ethnic make-up, and adult service systems will reduce bias due to 
unrepresentative samples.  
 
We will also examine mechanisms of action and explore moderators of treatment response 
and barriers to participation. Our sample is sufficient to test our research questions (based 
on out statistical Power analysis). We will collect data from youth with ASD and their 
parents, to reduce informant bias. Post-randomization data collection will be conducted 
by personnel blinded to study condition. Based on existing research, we would expect that 
parents who receive the written materials might have some increase in knowledge about 
adult services, but likely not empowerment nor would we expect change in youth 
outcomes. 
 
The ASSIST program is a 12-week advocacy training to educate parents of youth with 
ASD about the adult service system. It is a group training, comprised of didactic 
instruction, family-sharing activities, case studies, and group discussions. Due to social 
distancing restrictions during the COVID-19 pandemic, the intervention will be conducted 
via web-conferencing. The ASSIST program for the proposed study will be directed at 
each site by an experienced Program Facilitator from the community with knowledge 
about group processes, person-centered planning, and adult service systems, who will be 
coached by a member of the study team. The ASSIST program will be delivered in full 
partnership with the local disability community. In most sessions, the Program Facilitator 
will be aided by community content experts who present the specifics of each topic. 
Experts will include representatives from the Parent Training and Information Centers, 
The Arc, the University Centers for Excellence in Developmental Disabilities, various 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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government agencies, attorneys, and parents of individuals with ASD. We have tentatively 
identified (and partially recruited) most of these community experts at each project site. 
 
Finally, we take further steps to ensure that parental advocacy reflects the goals of the 
youth with ASD by: having a semi-structured discussion with the youth with ASD and their 
supporters about that youth's hopes, dreams, and goals prior to their parent taking the 
ASSIST program; developing individualized goals for transition outcomes from those 
discussions that will be used as an outcome measure; and including the youth with ASD 
in follow-up data collection to incorporate their perspective. 
 
Specific Aims 
 
Specific Aim 1. To use a multi-site RCT to examine whether ASSIST participation increases 
the intervention target of parent advocacy ability (defined by parental knowledge about 
adult service systems, advocacy skills, empowerment, and advocacy activities). 
Hypothesis. Relative to a materials-only control group, ASSIST participation will lead to 
improvements in parental knowledge about adult services, advocacy skills, empowerment, 
and advocacy activities. 
 
Specific Aim 2. To test whether participating in ASSIST leads to increases in employment, 
PSE, social participation, and access to services that facilitate these activities (number of 
services, unmet service needs, barriers), for youth with ASD transitioning from high school 
to young adulthood. 
Hypothesis. Relative to the materials-only control group, youth whose parents participate 
in ASSIST will have increased access to services and higher rates of employment, PSE, 
and social participation at 6-months and 12-months post-intervention. 
 
Exploratory Aim 2a. We will examine whether ASSIST participation leads to enhanced goal 
attainment (as assessed by parents and youth with ASD), as well as better youth-reported 
quality of life and fit of employment/educational activities to the youth's skills and 
interests. 
 
Exploratory Aim 2b. Using data collected 24-months and 30-months after intervention, we 
will examine whether treatment effects are maintained, strengthen, or wane. 
 
Specific Aim 3. To examine which intervention targets (parent knowledge, advocacy skills, 
empowerment, advocacy activities) mediate the relations between ASSIST participation 
and youth outcomes of employment, PSE, social participation, service access, and goal 
attainment. 
Hypothesis. In contrast to other intervention targets changed by ASSIST, parental 
empowerment will be the mechanism by which ASSIST participation leads to 
improvements in youth employment, PSE, social participation, service access, and goal 
attainment. 
 
Exploratory Aim 4. To guide further adaptations of ASSIST, we will explore moderators of 
treatment response and barriers to participation in the intervention. We will explore factors 
that could relate to parents' ability to complete the ASSIST program and treatment 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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response, including: youth's intellectual functioning, pre- vs. post-high school exit, 
attendance at ASSIST sessions, socio-economic status, parental education, community 
size, family stress, and number of children with ASD in the family. We will also analyze 
qualitative data to inform future efforts to increase the accessibility of the ASSIST program 
for individuals with ASD. 
 
If the aims of the study are achieved, the ASSIST program has the potential to be rapidly 
adopted and broadly implemented. Already we have received interest in providing the 
ASSIST program from multiple research groups and organizations across the country. Yet, 
a roadblock to dissemination is ASSIST's regional specificity. If a nationally relevant 
program is developed and shown to be effective, it can be incorporated into parent training 
services offered through national advocacy organizations and state/local governments. 
Further, because we train parents to advocate for both formal and informal supports, the 
ASSIST program will be broadly relevant to families of transition-aged youth regardless of 
the availability of adult services in their area. Given the high prevalence of ASD and of 
poor adult outcomes, as well as the geographic variability in services, it is critical to 
investigate an intervention such as the ASSIST program, which can be delivered through 
state or local agencies and can operate across an array of adult support landscapes. The 
proposed research is thus highly significant and has the potential for tremendous impact 
on both research and practice. 
 
Innovation 
 
This project features five major innovations: 
1. Life Stage. While of monumental concern to families, the transition to adulthood 
has been relatively ignored by researchers. By testing a parent advocacy 
intervention to improve youth outcomes, this project will make substantial 
contributions to knowledge of how to improve the transition years for youth with 
ASD. 
2. Parent-Centered. Traditional approaches to improving outcomes for transition-
aged youth with ASD target individual skills or changing systems. Instead, the VAP-
T focuses on parents. This approach allows for the development of programs for 
youth across the spectrum of functioning, including those with low cognitive 
abilities who often are excluded from interventions. If we demonstrate that parent-
focused programs improve youth outcomes, similar strategies can be applied to 
interventions for people with ASD across the lifespan (from early intervention 
through adulthood), opening up new treatment opportunities.   
3. Expanded Outcomes. In the VAP-T, we move beyond an emphasis on 
competitive employment, and instead focus on an expanded list of outcomes. 
These include access to needed services in PSE, health, financial support, housing, 
employment, and self-determination, which in turn foster fulfilling day-to-day 
activities and greater community engagement. Such an expanded – but specific – 
sense of adult success is rarely if ever included in intervention studies. 
4. Formal and Informal Supports. We adopt a larger sense of services and 
resources, including but going beyond formal service systems. In most states, 
adult services are under-funded and fragmented. Thus, while we provide 
knowledge about various services, agencies, eligibility requirements, and other 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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issues, we also provide parents with information about additional resources – 
everything from disability-related call lines and parent groups, to names of local 
businesses amenable to hiring young adults with ASD. By expanding the focus to 
both formal and informal resources, we increase the likelihood that ASSIST can be 
broadly implemented, to areas with and without abundant adult services. 
5. More Nuanced Understandings of Treatment Effects. The service needs of 
adults with ASD differ based on their personal characteristics and other factors 
such as stage of life. In keeping with the recommendation of Hoagwood et al., we 
will examine a limited number of targeted moderators of treatment response. We 
will assess the degree to which parents of offspring with different intellectual 
abilities benefit from ASSIST, and whether benefits depend on if the youth is in or 
out of high school. This will provide important evidence to suggest who might 
benefit most from the ASSIST program, as well as insight into how the program 
might be adapted to better serve those who are less responsive to ASSIST. 
 
3. Inclusion/Exclusion Criteria 
 
The goal of this study is to arrive at a sample of 180 families (one parent and one youth 
with ASD per family). We will recruit 2 cohorts of 90 families per cohort.  Each of the three 
sites will recruit and test participants over the course of the study: 
 
 
Vanderbilt University Medical Center: n=60 (cohort 1 n=30, cohort 2 n=30) 
 
University of Wisconsin-Madison: n=60 (cohort 1 n=30, cohort 2 n=30) 
 
University of Illinois at Urbana-Champaign: n=60 (cohort 1 n=30, cohort 2 n=30) 
 
The to-be recruited participants for the ASSIST study will be parents of youth with ASD in 
the transition years, and the youth with ASD themselves. 
 
Families must meet the following criteria according to the parent/legally authorized 
representative (LAR) (of the youth with ASD) to be eligible for the ASSIST study: 
 
• 
Parents willing to participate in the ASSIST 12-week intervention, who have an 
offspring with ASD between the ages of 16 and 26 years; There is no minimum 
or maximum age restrictions for the parent. 
• 
Parents are willing to be randomized to the treatment or control condition; 
• 
Parents are able to travel weekly to one of the project sites (Nashville, TN; 
Chicagoland; IL; Madison/Milwaukee, WI) to participate in the group ASSIST 
sessions (12 weekly sessions). The responding parent and his/her son/daughter 
with ASD must also be able to travel to a project site once if social distancing 
restrictions allow (for a diagnostic evaluation and baseline data collection visit); 
• 
Family lives in one of the three states that will test ASSIST (TN, IL or WI), as 
the ASSIST curriculum will be state specific. 

National Institute of Mental Health. Award # R01MH116058S 
Protocol Title: Project ASSIST: Advocating for SupportS to Improve Service Transitions 
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• 
The son/daughter has a previous diagnosis of ASD from an educational or 
health care provider, and meets lifetime cut-offs for ASD in a telephone screening 
of the Social Communication Questionnaire (SCQ score >=151); and 
• 
The participating parent is proficient with the English language, as all ASSIST 
presentations and data collection materials are in English. 
 
If both parents in a family want to attend the ASSIST training, we will allow it but will 
designate one parent as the study's primary respondent. 
 
 
4. Enrollment/Randomization 
 
Given our need to ascertain whether participants meet the study eligibility requirements 
prior to arranging for families to enroll in the study, we will obtain oral agreement to talk 
with the parent/caregiver/LAR/legal guardian about the details of the study and proceed 
with the eligibility phone-screening interview in order to determine whether the project is 
a good fit for the prospective participant/family. 
 
After families are screened and determined potentially eligible, if they decide to enroll in 
the project, they will be invited to complete the baseline data collection visit. At each site, 
written/electronic and oral consent will be provided by caregivers/LARs. Verbal and 
(whenever possible) written/electronic assent will be obtained from all minors and youth 
who have a LAR, prior to data collection (during their first visit). Youth with ASD who are 
able to consent for themselves will provide written/electronic and oral consent for 
participation in the study. 
 
The consenting procedure will be as follows: 
 
1. The study team member (hereafter STM) who completed the screening phone interview 
with the parent / LAR, will make initial determinations about the son/daughter's ability to 
consent based on: a) his/her age at the time of the baseline data collection visit; and 2) 
if over 18, whether the parent is the legally authorized representative of the son/daughter 
or whether he/she is his/her own representative. 
 
2.  Consent forms will be sent to research participants via email ahead of time so that 
they have an opportunity to become familiar with them prior to the study visit.  
 
 
1 Please note that in rare cases, a youth with a previous diagnosis of ASD may score between 10 and 14 in 
the SCQ (due to limitations to all psychometric measures). In these situations, the PI will review the responses 
provided by the parent during the phone screening interview, and determine if the family may still be a good 
fit for the study. If after careful consideration, the PI determines that the family is eligible to participate, that 
family will be enrolled in the study. This is by no means a general rule, and study key personnel will be 
instructed to follow the proposed inclusion / exclusion criteria, and review with the PI any “borderline cases” 
(e.g. someone who was given an ASD diagnosis that does not seem appropriate based on parent responses 
and SCQ score; someone who has a previous ASD diagnosis but the parent is not a good reporter of that 
youth’s behaviors as a child, thus, obtaining a SCQ score that falls below the threshold, etc.). 
 

National Institute of Mental Health. Award # R01MH116058S 
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3. At the baseline study visit, research staff members will review the consent forms with 
the parent and the son/daughter in person or through teleconference. The research team 
member will address all questions or concerns the participants may have during the 
informed consent process. The research team member will also minimize coercion and/or 
undue influence by: (1) assuring potential subjects (and withdrawing subjects) that their 
decision not to participate or decision to withdraw from the study will not affect other 
services they or the son/daughter with ASD are currently receiving (2) refraining from 
providing any unjustifiable assurances about benefits, risks or inconveniences of the 
research. If the parent agrees to participate, he/she will sign the written/electronic 
consent form. If the son/daughter consents or assents to participate, the research team 
member will make sure that the young participant understands what the study involves, 
that this is a voluntary study and that he/she can withdraw from the study at any point. 
 
4. Participants who consent to participate will sign a hard-copy/electronic copy of the 
consent form. Each site will keep the original signed copy and participants will receive a 
copy of the signed consent form. During the informed consent process, participants will 
be reminded that participation in the study is voluntary and that they can decide to 
withdraw from participating at any time without penalties or negative consequences. 
 
Note: When a STM is consenting a youth who is over 18 (and who does not have a legally 
authorized representative), the STM will stop after each section of the consent form, and 
ask a comprehension question. If the youth is unable to answer the questions, or if it is 
unclear whether he/she is fully comprehending the consent form, the STM will shift to the 
assent script with the youth, and ask the LAR/parent to provide consent for the 
son/daughter's participation. 
 
Randomization 
 
After eligibility is determined and baseline data are collected, parents will be randomized, 
in two cohorts, to the treatment or materials-only control condition. Given the relatively 
small sample size in each cohort at each site (n = 30 at each of three sites), simple 
randomization is not recommended as it might result in unequal group sizes. We will use 
1:1 block randomization within each site to give an equal number of subjects in each 
group. To ensure balance of important covariates, we will block on our key moderators: 
whether the youth has an intellectual disability (ID) and is in high school. Co-occurring ID 
and being in vs. out of high school impact service eligibility, and ID impacts the likelihood 
of PSE and community employment. By balancing moderators, we maximize our power to 
detect effect modification of the treatment effect; and we minimize the chance of having 
a very extreme distribution of important (moderating) covariates. 
 
1.0 
Study Procedures 
 
All data collection will occur in years 2019-2023 as explained below: 
 
• 
Enrollment for the project is expected to occur in years 1-2. 
• 
Cohort 1 (C1) Intervention group will take ASSIST from February-August 2020 (IL 
and TN sites; includes COVID break) and August-November 2020 (WI sites)   

National Institute of Mental Health. Award # R01MH116058S 
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o  C1 Control group will take ASSIST September-November 2021 (TN and IL 
Sites) and January-March 2022 (WI Site)  
• 
Cohort 2 (C2) Intervention group will take ASSIST from August-Nov 2020 (TN and 
IL Sites) and November 2020-Feburary 2021 (WI site) 
o C2 control group will take ASSIST from February-April 2022 (TN and IL) 
and March-May 2022 (WI sites). 
Note: Due to social distancing restrictions, the in-person intervention series that began in 
February 2020 was paused between Spring 2020 to Summer 2020 for Cohort 1 
intervention groups (TN and IL). In response to continued pandemic regulations, ASSIST 
was moved to synchronous web-conferencing in Summer 2020, and this method was the 
mode of delivery for all remaining sessions and series at all sites (TN, IL, WI) 
 
A comprehensive characterization of each participant’s circumstances and family context 
will be completed by administering a battery of direct assessments and informant report 
measures during the baseline visit. This visit will include structured observations, 
psychological testing, structured interviews, and questionnaires/surveys. Note that some 
of the survey measures will be offered to participants as web-links to be filled out at home 
or at the lab if social distancing restrictions allow. Paper copies of all surveys will be 
available based on participant preference.  
 
Follow-up data collection points (post-intervention, 6, 12, 18, 24, and 30 months) may 
take place online or over the phone, depending on participants' preference and the 
included measures to be collected for that time-point. We will also make alternate methods 
of data collection available to youth with ASD for the interview, including video/text/online 
chat, as some participants with ASD may be more comfortable answering questions via 
chat than over the phone or web conference. The table of measures included in the 
Procedures for Enrolled Families section of this protocol, shows the longitudinal measures 
follow-up schedule for parent and youth participants. 
 
5. Procedures 
 
Eligibility Screening Procedures: Staff at each site will inform potential participants of 
the study, when subjects contact the site (via email, phone and/or interest form survey) 
in response to recruitment efforts. As soon as the potential parent participant is available, 
staff at each site (depending on the state of residence of the subject) will conduct a 
telephone screening interview with the subject’s verbal permission. All screening phone 
interviews will be completed with parents (never with a youth with ASD) using the phone 
script electronically and/or in paper/pencil. During the eligibility screening phone call, the 
study team member will administer the Social Communication Questionnaire (SCQ – 
Rutter, Bailey, Kazak, Lord & Pickles, 2003) to the parent / LAR (as one of the eligibility 
inclusion criteria for the study is that the score on the SCQ Lifetime Questionnaire is 15 
or higher; although in rare circumstances, a score between 10-14 may not prevent a 
family from participating in the study – this will be evaluated by the PI on a case by case 
basis). The SCQ offers a quick and easy way to screen for autism spectrum disorders by 
asking caregivers 40 yes/no question about the child's communication skills and social 
functioning.  
 

National Institute of Mental Health. Award # R01MH116058S 
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If after the telephone screening, the STM determines that the family is not eligible to 
participate in the study, we will explain this to the parent. We will destroy any record of 
the parents' responses to the screening phone call questions, unless the family says they 
would like to be contacted for future studies. For reporting purposes only, we will 
document the reason for ineligibility of the screened family (e.g. the son/daughter never 
received a diagnosis of an ASD) in a “recruitment tracking document” that will not include 
any of the screened subject’s PHI or responses. 
 
Procedures for enrolled families: For each participating family, the testing battery at 
baseline will be the most extensive one. After that, the number of administered 
instruments will vary depending on the specific follow-up data collection time. Similarly, 
depending on the number and type of instruments to be collected during the follow-up 
data collection times; study staff at each site will collect the data via: phone interview or 
teleconference, REDcap survey, and/or paper protocols; depending on the family’s 
preference. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Youth measures 
Test / Procedure 
Baseline 
(T0) 
 
12-m FU 
(T3) 
 
30-m FU 
(T6) 
Youth (Baseline) 
 
T0 
T3 
T6 
Autism Diagnostic Observation Schedule: 
(ADOS-2; Lord et al., 2012) A semi-structured 
standardized observational assessment of social 
interaction and communicative skills that was 
designed as a diagnostic tool for identifying the 
presence of autism. It is organized into four 
modules, which are distinguished by their 
appropriateness for use with individuals functioning 
at different developmental levels, ranging from 
nonverbal children to highly fluent adults. Each 
module provides a set of behavioral ratings in five 
domains: Language and Communication, Reciprocal 
Social Interaction, Play or Imagination/Creativity, 
Stereotyped Behaviors and Restricted Interests, 
and Other Abnormal Behaviors. We will mainly use 
Module 3 and 4 (dedicated to verbally fluent 
teenagers and adults), and Module 1 and 2 (that 
can be used for non-verbal adults or less verbal 
adults). The scoring algorithm provides cutoffs that 
can be used to discriminate between a diagnosis of 
autism, autism spectrum, or non-spectrum. The 
ADOS will be administered to participants with ASD. 
It will be administered by trained research staff. All 
ADOS-2 administrations will be video-recorded with 
the participant's explicit consent. Note: After data 
collection was moved online due to social 
distancing restrictions, the ADOS-2 was no longer 
required as a diagnostic measure for remaining 
participants.) 
X 
 
 

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Wechsler Abbreviated Scale of Intelligence 
(WASI-II, Wechsler, 2011): Provides a brief, 
reliable measure of cognitive ability for use in 
clinical, educational, and research settings. It is 
comprised of 4 subtests that yield a verbal 
intelligence quotient, a performance quotient, and 
an overall intelligence quotient. (Note: After data 
collection was moved online due to social 
distancing restrictions, the research staff used 2 of 
the subtests which were able to be administered 
virtually. The other 2 subtests were not 
administered to remaining participants.) 
X 
 
 
Youth Measures  (Longitudinal) 
T0 
T3 
T6 
Vocational - educational activities interview: 
(Taylor & Seltzer, 2012) 
this instrument gathers information on vocational, 
educational, and other daytime activities. A trained 
research staff member will deliver this brief 
interview to gather information on current and 
previous high school employment, secondary 
education and post-high school vocational 
placements. 
X 
X 
Goal identification (baseline) / Goal 
Attainment (FUs):  Our team developed a goal 
bank that includes goals that fall into 5 categories: 
Employment & Post-Secondary Education, Daily 
living, Social and Spirituality, Healthy Living, and 
Safety & Security. This goal bank is a start point to 
help families think about a vision for how their 
family member will live their life as an adult. The 
parent will select 5 potential goals from the goal 
bank, and work with a study team member to 
customize the selected goals during the baseline 
visit.   After that, the youth will review the 
customized goals and/or select three of them that 
he/she is interested in (or create new customized 
goals if none of the goals the parent customized are 
of the youth’s interest). Goals that are specified 
during this identification session will be scaled using 
Goal Attainment Scaling (GAS). GAS is an 
individualized outcome measure to calculate the 
extent to which specific goals are met by an 
individual. Goal selection will vary from participant to 
participant, but the goal scale will be standardized to 
measure goal attainment consistently across 
X 
X 

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participants. During FUs, study staff will reach out to 
the youth participant and check in on goal progress 
status. 
Self-Determination Inventory System Adult 
(SDIS – ADULT): The SDIS (Shogren et al., 2017) 
is a 22-item survey that asks adults how they feel 
about their ability to be self-determined; make 
choices, set and go after goals, and make decisions.  
Participants use a sliding scale to indicate their level 
of agreement with various statements related to 
self-determination. 
X 
X 
X 
Transition Empowerment Scale (TES): Adapted 
from the Family Empowerment Scale (FES; Koren, 
DeChillo, & Friesen, 1992) to measure adolescents 
and young adults with disabilities’ perceived 
empowerment during transition planning.  This 
modified 31-item instrument enables young adults to 
self-report how empowered they feel to manage 
their day-to-day life, understand the services 
available to them, and advocate for themselves and 
for other adolescents with disabilities.  The young 
adult rates statements from 1 (Not True) to 5 (Very 
True) to indicate how much each one applies to 
him/her.  The scale captures the young adult’s view 
of their own empowerment at one point in time by 
measuring both the level of empowerment and how 
it is expressed. 
X 
X 
X 
Satisfaction with Life Scale (SLS): the SLS 
(Diener et al., 1985) is a short 5-item measure of an 
individual’s subjective quality of life. Participants rate 
their agreement with 5 statements on a 7-point 
scale, from 1 (Strongly Disagree) to 7 (Strongly 
Agree).   
X 
X 
X 
 
 
 
 
Open-Ended Questions: Participants give their 
opinions on future intervention programs for people 
with ASD 
 
 
X 
 
 
 
 
 
 
 
 
 
 

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Parent measures 
Test/ procedure 
Baselin
e (T0) 
Post-
test 
(T1) 
6-m 
CI 
(T2) 
12-m 
FU 
(T3) 
18-m CI 
(T4) 
24-m 
CI (T5) 
30-m 
FU (T6) 
Youth /Parent 
Characterization (Baseline) 
T0 
T1 
T2 
T3 
T4 
T5 
T6 
Demographics and medical 
history: Demographic 
information for NIH reporting, 
as well as diagnostic and 
treatment information. 
X 
 
 
 
 
 
 
Vineland 3- Comprehensive 
Interview form: (Sparrow, 
Cicchetti & Saulnier, 2016) a 
measure of adaptive behavior 
functioning. It is administered 
as a brief interview to parents 
or caregivers, and yields 
standard scores and age 
equivalents in the domains of 
communication, social, daily 
living skills and overall adaptive 
functioning.  
X 
 
 
 
 
 
 
Social Responsiveness 
Scale, Second Edition: (SRS-
2, Constantino & Gruber, 2012) 
A 65 item parent-report scale 
measuring the presence and 
severity of social impairment as 
it relates to Autism Spectrum 
Disorder. The measure is 
sensitive enough to quantify 
severity within the spectrum 
and differentiate between ASD 
and other disorders. The SRS-2 
generates a total score as well 
as scores for each of its five 
subscales: social awareness, 
social cognition, social 
communication, social 
motivation, and restricted 
interests and repetitive 
behavior. The SRS-2 parent-
report will be given to parents 
of all participants with ASD. 
X 
 
 
 
 
 
 
Participants will complete the 
ABCL or the CBCL, depending 
X 
 
 
 
 
 
 

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on their youth’s age. Parents of 
youth ages 16-17 will complete 
the CBCL, and parents of youth 
age 18 and over, the ABCL. 
Child Behavior Checklist 6-
18 (CBCL; Achenback & 
Rescorla, 2001) A 113-item 
scale designed to be rated by 
parents of children aged 6-18. 
The questions are scored on a 
three-point Likert scale 
(0=absent, 1=occurs 
sometimes, 2=occurs often). 
The time frame for item 
response is in the past six 
months. 
Achenbach Adult Behavior 
Checklist 18-59: (ABCL; 
Achenbach & Rescorla, 2003) A 
118-item scale designed to be 
rated by parents of adult 
children aged 18 to 59. The 
ABCL is based on a multi-factor 
model, for which domains of 
withdrawn, somatic problems, 
and anxious depressed are 
indicators of a more general 
"Internalizing" factor, while 
delinquency and aggression 
domains are indicators of the 
"Externalizing" factor (Tenneij 
& Koot, 2007). 
Coping Orientation to 
Problems Experienced 
(COPE) Inventory: (Carver, 
Scheier, & Weintraub, 1989) 
multidimensional coping 
inventory to assess the 
different ways in which people 
respond to stress. Participants 
rate 60 items with potential 
responses to stress on a scale 
from 1 (I usually don’t do this 
at all) to 4 (I usually do this a 
lot).   
 
 
X 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Parent Repeated measures 
(Longitudinal)  
T0 
T1 
T2 
T3 
T4 
T5 
T6 
Family Empowerment 
Scale: (FES; Koren, DeChillo, 
& Friesen, 1992) developed 
specifically to assess 
empowerment in families with 
children with emotional 
disorders. The FES consists of 
34 items with responses on a 
Likert scale ranging from 1 
(Not true at all) to 5 (very 
true). 
X 
XT 
 
XT 
X 
 
X 
Parent Advocacy Skills and 
Comfort (ASC) & 
Knowledge measure: Both 
of these measures were 
developed by the ASSIST team. 
The Advocacy Skills and 
Comfort (ASC) measures the 
degree to which parents feel 
comfortable and skilled in 
advocating for their 
son/daughter with ASD. The 
assessment comprises 10 
items, on which participants 
respond on a 5-point Likert 
scale (1 = not at all; 2 = below 
average; 3 = average; 4 = 
good; 5 = excellent). The 
Knowledge measure serves to 
examine the extent of parents’ 
knowledge about the  adult 
service system through a scale 
developed for this project 
(based on a measure 
developed to evaluate the VAP-
T; Burke, Goldman, Hart, & 
Hodapp, 2016). Each response 
will be coded as either 
“correct” (1) or “incorrect” (0), 
with potential scores ranging 
from 0 to 22 and higher scores 
equaling greater knowledge of 
the adult disability service 
X 
XT 
 
XT 
X 
 
 

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system.  This measure was 
piloted among a group of 
parents of older sons and 
daughters with ASD to ensure 
that floor and ceiling effects 
were avoided. 
Vocational - educational 
activities interview: (Taylor 
& Seltzer, 2012) 
A trained research staff 
member will deliver this brief 
interview to gather information 
on current and previous high 
school employment, secondary 
education and vocational 
placements that the 
son/daughter is/was involved 
in. 
X 
 
XP 
XP 
 
X 
X 
Service Access questions 
Interview (NLTS2 
questions and team-
developed questions): The 
National Longitudinal Transition 
Study-2 (NLTS2) collected data 
over 10 years from parents, 
youth, and schools and 
provided a national picture of 
the experiences and 
achievements of young people 
as they transition into early 
adulthood. For the proposed 
research, we will use some of 
the questions developed for the 
NLTS2 concerning service 
access for youth with ASD, and 
will supplement them with 
questions developed for our 
research about specific types of 
services (e.g., Medicaid, etc.). 
These questions will be 
answered by parents using a 
semi- structured interview 
format 
X 
 
XP 
XP 
 
X 
X 
Parent Advocacy Activities 
Measure: (Taylor et al., 2017) 
this instrument has 16 items 
that measures how frequently 
X 
 
 
XP 
 
 
X 

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parents spend time in advocacy 
activities for their son/daughter 
with ASD. 
Goal identification 
(baseline) / Goal 
Attainment (FUs):  Our team 
developed a goal bank that 
includes goals that fall into 5 
categories: Employment & 
Post-Secondary Education, 
Daily living, Social and 
Spirituality, Healthy Living, and 
Safety & Security. This goal 
bank is a start point to help 
parents think about a vision for 
how their family member will 
live their life as an adult. The 
parent will select 5 potential 
goals from the goal bank, and 
work with a study team 
member to customize the 
selected goals during the 
baseline visit.   After that, the 
youth will review the 
customized goals and/or select 
three of them that he/she is 
interested in (or create new 
customized goals if none of the 
goals the parent customized 
are of the youth’s interest). 
Goals that are specified during 
this identification session will 
be scaled using Goal 
Attainment Scaling (GAS). GAS 
is an individualized outcome 
measure to calculate the extent 
to which specific goals are met 
by an individual. Goal selection 
will vary from participant to 
participant, but the goal scale 
will be standardized to 
measure goal attainment 
consistently across participants. 
During FUs, study staff will 
reach out to the parent 
participant and check in on the 
youth’s goals’ progress status. 
X 
 
 
XS 
 
 
 

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Social Participation and 
employment correlates: The 
National Longitudinal Transition 
Study-2 (NLTS2) collected data 
over 10 years from parents, 
youth, and schools and 
provided a national picture of 
the experiences and 
achievements of young people 
as they transition into early 
adulthood. For the proposed 
research, we will use some of 
the questions developed for the 
NLTS2 concerning parent's 
social participation. In addition, 
we are including some 
questions developed to 
measure employment and 
social participation (Taylor, 
Adams, Bishop, 2017). 
X 
 
 
XS 
 
 
X 
Satisfaction with Life Scale 
(SLS) - proxy report 
regarding son/daughter:  
the SLS (Diener et al., 1985) is 
a short 5-item measure of an 
individual’s subjective quality of 
life. The SLS scale allows 
participants to integrate and 
weigh these domains in 
whatever way they choose.  
Participants rate their 
agreement with the 5 
statements on a 7-point scale, 
from 1 (Strongly Disagree) to 7 
(Strongly Agree).   
X 
 
 
XS 
 
 
X 
Depression, Anxiety, Stress 
Scales – 21 items (DASS-
21): (Lovibond & Lovibond, 
1995) set of three self-report 
scales designed to measure the 
emotional states of depression, 
anxiety and stress. Each of the 
three DASS-21 scales contains 
7 items, divided into subscales 
with similar content. The 
depression scale assesses 
dysphoria, hopelessness, 
X 
 
X 
 
X 

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devaluation of life, self-
deprecation, lack of interest / 
involvement, anhedonia and 
inertia. The anxiety scale 
assesses autonomic arousal, 
skeletal muscle effects, 
situational anxiety, and 
subjective experience of 
anxious affect. The stress scale 
is sensitive to levels of chronic 
nonspecific arousal. This scale 
assesses difficulty relaxing, 
nervous arousal, and being 
easily upset/agitated, 
irritable/over-reactive and 
impatient. 
General Life Events: 
assesses milestones, changes, 
and challenges that may have 
occurred in an individual’s life 
within the past year. The 
parent participant indicates 
whether he/she, his/her 
spouse, and his/her children 
have experienced any of the 22 
listed life events (e.g. 
marriage, divorce, moving to a 
new home, etc.) or other (item 
23). 
X 
 
 
X 
 
 
 
Disability Connectedness: 
This measure assesses the 
extent to which a participant 
relates to his/her local disability 
community.  The instrument 
consists of 10 items.  
Participants respond on a 5-
point Likert scale (1 = not at 
all; 2 = slightly; 3 = to some 
extent; 4 = quite a bit; 5 = 
very much so).   
X 
 
 
X 
 
 
X 
Parent-Child Relationship: 
this 10-item instrument 
(Bengtson & Schrader; 1982) 
measures a parent’s 
perceptions of how positive 
his/her relationship is with 
his/her child. Responses range 
X 
 
 
X 
 
 
 

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from 1 (Not at all) to 6 
(Extremely). 
Parent expectation 
questions from NLTS-2 
(same for all): The National 
Longitudinal Transition Study-2 
(NLTS-2; Sanford et al., 2011) 
documented the experiences of 
students nation-wide as they 
made their transition to 
adulthood.  The NLTS-2 
provides insight into the 
involvement of families in the 
educational development of 
high school-aged youth with 
disabilities.  The present study 
uses a modification of the 
parent expectations questions 
from the NLTS-2, Parent 
Expectations, which asks 
parents to speculate about 
their youth’s future at the end 
of and after high school.  This 
measure includes items about 
the youth’s potential 
employment, living situation, 
and postsecondary education. 
X 
 
 
X 
 
 
X 
Self-Determination 
Inventory System - Parent 
version (SDIS): (Shogren et 
al., 2017) measures a 
parent/family member’s 
perception of a young person’s 
self-determination.  This survey 
includes questions about goal-
setting, decision-making, and 
choice-making skills. Parent 
participants use a sliding scale 
to indicate their level of 
agreement with various 
statements related to self-
determination of their 
youth.The assessment 
comprises 22 items. 
 
X 
 
 
X 
 
 
X 
 
 
 
 
 
 
 
 

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Open Ended Questions: 
Participants give their opinions 
on the intervention program 
and feedback for future 
changes. 
 
 
 
 
 
 
X 
• 
Notes: CI: Check-in          FU: Comprehensive Follow-Up 
• 
Outcome Key: T (=Intervention Target) P (=Primary)  S (=Secondary) 
 
6. Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
Adverse events at any of the sites will be relayed immediately (within 24 hours of 
occurrence) to the VUMC PI and/or VUMC study coordinator by study staff at all sites. Dr. 
Julie Lounds Taylor (VUMC PI) will be responsible for reporting any adverse event to the 
IRB within 7 calendar days from the day of report. If additional risks to participants are 
identified, then, Dr. Taylor will disseminate information and guidelines to follow to the 
other participating sites. In addition, if data safety is compromised, the VUMC study 
coordinator will communicate with the other participating sites to provide guidance on 
what steps to follow to resolve or prevent the issue. 
 
7. Study Withdrawal/Discontinuation 
 
Participants may ask to withdraw from the study at any time with no penalty. If 
participants opt to withdraw for any reason at any point in the study, no further data 
collection will be conducted for that participant. Although the project is longitudinal, 
some of the analyses proposed involve data from only one time point; thus, early 
termination of a participant does not necessarily mean that his/her data cannot be 
included in the analyses. Records will be retained in instances of the early termination of 
a participant. 
 
8. Statistical Considerations 
 
Effects of the Intervention (Aims 1 and 2): Generalized linear models accounting for 
repeated measurements over time will be used to estimate the effect of treatment group 
assignment on each of the outcomes. In modeling, outcomes will be considered at their 
key time-points with treatment group and the interaction of treatment with time serving 
as the main explanatory variables. Such a model will allow us to test for differences 
between treatment and control groups over time while accounting for heterogeneity 
among subjects at baseline. While the randomized block design should minimize 
confounding, we will adjust for site and sex to improve precision. Regarding the choice of 
statistical model, we will use ordinary multiple regression for truly continuous responses, 
logistic regression for binary responses, and for outcome scales that are not truly 
continuous or have heavy ties in some of their values, the proportional odds ordinal logistic 
model. The error structure of the model is assumed to be compound symmetric, and the 
validity of this assumption will be examined by computing Akaike Information Criteria 
against other common structures. Mediation (Aim 3): To assess direct and indirect 
effects of potential mediator variables, we will follow steps outlined by MacKinnon and 

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colleagues to establish mediation. Mediation models will be estimated using the 
“mediation” package in R. Moderation (Exploratory Aim 4): Modifiers of treatment 
effect over time will be considered by introducing interactions between modifiers and the 
treatment by time interaction. The model building and validation strategy will otherwise 
be the same as for Aims 1 and 2. 
 
Power/Sample Size: We plan to recruit 180 subjects and expect to retain 152 through 
the 12-month follow-up (76 per cohort). For power calculations, we consider baseline to 
post-test changes. For continuous outcomes, the size of effect that we will have 80% 
power to detect will be impacted by the correlation between the pre and post 
measurement of the outcome.  At worst (r=0), we will have 80% power to detect a 0.46 
sd difference in continuous outcomes.  If the correlation is 0.2 or 0.4 we will be able to 
detect a 0.29 or 0.17 sd difference, respectively. We believe these estimates are 
conservative because, from our pilot work, correlations between baseline and post-test 
scores of intervention targets were 0.56 (empowerment), 0.39 (advocacy skills), and 0.57 
(knowledge). For binary outcomes, the probability of being employed or in PSE was about 
0.5 in pilot data; under this assumption we will have 80% power to detect a relative risk 
of 1.44.  For Aim 4, we will have 80% power to detect a 0.42 sd modification of the 
treatment effect assuming a r=0.2. All calculations assume a two-sided significance level 
of 0.05. The power to detect mediation effects were made using the MedPow package 
in R. For the power calculation, we considered moderate associations between (1) VAP-T 
and the mediator (rX,M=0.3), (2) Mediator and outcome, controlling for VAP-T 
(rM,Y|X=0.25), (3) VAP-T and outcome controlling for the mediator ((rX,Y|M=0.1) using 
a fixed sample size of 152 (α=0.05). Under these assumptions, we have 83% power to 
detect the indirect effect of VAP-T on the outcome through the mediator. 
 
9. Privacy/Confidentiality Issues 
 
IRB approval will be obtained prior to the initiation of the project. All project staff will be 
highly experienced in working with these populations, will have completed University 
mandated Human Subject Research Ethics training, and will be instructed in procedures 
for ensuring participant rights and confidentiality. 
 
To protect confidentiality of participants, we will separate names and contact information 
from all other data. Participant codes, rather than names, will be used to index all data. 
Contact information, including names, must be maintained during this longitudinal study 
as participants must be scheduled for follow-up visits and all data files must be linked. 
Consent, contact information, and information linking participant identity with participant 
codes will be stored separately from all coded data. 
 
Hard copies of data protocols will be stored in locked and secure cabinets accessible only 
to project staff. Electronic records with identifiers will be stored in a password-protected 
database. All lab personnel will be instructed as to the nature and confidentiality principles 
and procedures. The link between participant ID numbers and participant names will be 
destroyed when the project has been closed out with the IRB.  
 

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We will also video-/audio-record all the ADOS-2 administrations in their entirety ( for visits 
before COVID-19 restrictions were established). This will allow us to perform fidelity 
checks and testing calibration. Parent and youth interviews completed during the baseline 
visit (Vineland 3, Vocational Index, Service Access Interview, and Goal identification) will 
be audio-recorded for reliability purposes. In addition, such recordings of sessions will 
allow us to re-score protocols that may need to be checked or that were difficult to score 
while they were being administered, and to complete the transcription and coding needed 
for the present project. As lead site for the project, the recordings will be centralized at 
VUMC. A secure cloud storage service such as Box/SharePoint/OneDrive will be used to 
safely transfer data in transit to the cloud with secure connections. Once stored on the 
cloud, data will be secured using file encryption. As an additional layer of security, users 
will receive a unique username and password to log into the service. Every effort will be 
made to ensure that the data is kept confidential. 
 
A REDCap project created and managed by the VUMC research team will be used as a 
central location for data management. Vanderbilt University, with collaboration from a 
consortium of institutional partners, has developed a software toolset and workflow 
methodology for electronic collection and management of research and clinical trial data. 
REDCap (Research Electronic Data Capture) data collection projects rely on a thorough 
study-specific data dictionary defined in an iterative self-documenting process by all 
members of the research team with planning assistance from the VUMC PI and research 
coordinator. The iterative development and testing process result in a well-planned data 
collection strategy for individual studies. The REDCap system provides secure, web-based 
applications that are flexible enough to be used for a variety of types of research, provide 
an intuitive interface for users to enter data and have real time validation rules (with 
automated data type and range checks) at the time of entry. These systems offer easy 
data manipulation with audit trails for reporting, monitoring and querying patient records, 
and an automated export mechanism to common statistical packages (SPSS, SAS, Stata, 
R/S-Plus). REDCap servers are housed in a local data center at VUMC and all web-based 
information transmission is encrypted. REDCap was developed specifically around HIPAA-
Security guidelines. REDCap has been disseminated for use locally at other institutions 
and currently supports 240+ academic/non-profit consortium partners on six continents 
and over 26,000 research end-users (www.project-redcap.org). 
 
10. Follow-up and Record Retention 
 
Data will be collected in Years 1-4 of the project. Hard copy materials with identifying 
information will be maintained (at each site) for 6 years after the closure of the study, 
then destroyed. All electronic files (de-identified data, video and audio recordings) will be 
kept indefinitely.