An interventional study of Pathways and Resources for Engagement and Participation (PREP) in Autism, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
This project seeks to evaluate the feasibility and acceptability of a remote metacognitive strategy training intervention in transition-age autistic adolescents and young adults and a primary caregiver. We will also conduct limited efficacy testing.
The U.S. healthcare and educations systems are failing autistic adolescents and young adults (AYAs) through inadequate or inaccessible services that hinder the development of independent living skills for long-term participation, health, and the transition to adulthood. In fact, only 19% of autistic AYAs who received special education services live independently and just over half were employed by their early 20s. These trends negatively impact autistic people's health and well-being and result in substantial familial and societal costs ranging from $1.4 to $2.4 million per person. Existing rehabilitation interventions for autistic AYAs primarily target isolated skills and overlook caregiver influences on AYA outcomes, so intervention gains do not translate to improvements in long-term participation or transition outcomes.
Pathways and Resources for Engagement and Participation (PREP), an MCST intervention for AYAs with physical disabilities and their families, may improve participation, health, and transition outcomes in autistic youths. PREP is a problem-solving approach to family-chosen goals that focuses on activity or environmental modifications over skill development. PREP improves activity performance and participation in AYAs with physical disabilities and autistic children ages 6-12. However, PREP has not been rigorously tested with autistic AYAs and caregivers. The critical next step is to test whether PREP improves participation, health and well-being, and transition outcomes in autistic AYAs. The overall study hypothesis is that PREP will be feasible for autistic AYAs and caregivers.
We will conduct a randomized controlled trial with waitlist crossover in autistic AYAs and their caregivers (e.g., youth-caregiver dyads). Youth-caregiver dyads will include one autistic AYA and one primary caregiver that meet other study inclusion criteria and provide electronic informed consent and assent. AYA-caregiver dyads will complete a baseline assessment (T1) of AYA activity performance, participation, and mental health. Then, they will be randomly assigned to intervention or waitlist control groups. The intervention group will complete remote PREP immediately (one hour/week x 12 weeks), and the waitlist control group will wait 12 weeks without intervention and then complete remote PREP (one hour/week x 12 weeks). The intervention group will complete post-intervention (T2) and follow-up (T3) assessments. The waitlist control group will complete second baseline (T2) and post-intervention (T3) assessments. AYA-caregiver dyads will complete one in-depth, semi-structured interview post-intervention to determine intervention acceptability.
We aim to test the feasibility of remote PREP for autistic AYAs and their caregivers. We hypothesize that feasibility data (e.g., recruitment, retention, and intervention adherence) will indicate that the study protocol and intervention can be implemented with autistic AYAs and a primary caregiver. We also hypothesize that acceptability data will indicate adequate intervention acceptability and inform optimization for future trials. Our second aim is to conduct limited efficacy testing to identify the preliminary effect of remote PREP on AYA outcomes. We hypothesize that effect size estimations will indicate the remote PREP has a greater positive effect, compared to waitlist control, on AYA activity performance, participation, health, and transition outcomes.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 24 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention group will complete the remote metacognitive strategy training intervention immediately.
Behavioral: Pathways and Resources for Engagement and Participation (PREP)
The waitlist control group will wait 12 weeks without intervention. Then, they will crossover into the intervention arm and receive the remote metacognitive strategy training intervention.
Pathways and Resources for Engagement and Participation (PREP) is a collaborative problem-solving intervention that targets environmental barriers-physical, social, attitudinal, familial, and institutional-while leveraging adolescent and family strengths. Caregivers are integrated as key supports. The five-step process includes: (1) make goals, (2) map out a plan, (3) make it happen, (4) measure outcomes, and (5) move forward. We will set four activity-based transition goals using the Transition Planning Inventory-2nd Edition and Goal Attainment Scaling. Providers will use guided discovery to help adolescents and caregivers identify strategies that modify activities or environments to support participation in transition activities. Adolescents and caregivers will implement strategies between sessions and revise strategies with the provider in future sessions if unsuccessful. Participants will complete 12 weekly 60-min remote PREP sessions over 12-16 weeks.
Acceptability of Intervention Measure (AIM)
Measure of intervention acceptability. Self-report Likert scale from 1 -completely disagree to 5 - completely agree
Time frame: Intervention - week 13; Waitlist control - week 25
Semi-Structured Interview
A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention. Data will be qualitative interview transcripts.
Time frame: Intervention - week 13; Waitlist control - week 25
Participation and Environment Measure - Child and Youth
Caregiver proxy report measure of adolescent activity participation at home, school, and in the community. Caregivers rate adolescents' participation frequency (0 - never to 7 - daily) and involvement (1 - minimally involved to 5 - very involved). Higher scores represent better adolescent participation.
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist control- Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Youth, Young Adult Participation and Environment Measure
Self-report measure of adolescent and young adult activity participation at home, school, and in the community. Adolescents and young adults rate their participation frequency (0 - never to 7 - daily) and involvement (1 - minimally involved to 5 - very involved). Higher scores represent better adolescent participation.
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist Control - Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Patient-Reported Outcomes Measurement Information System Pediatric Global Health Measure 7+2
Informant and self-report questionnaire of adolescent and young adult physical and mental health. Item responses range from 1 - poor to 5 - excellent. Higher scores represent better health.
Time frame: Baseline (week 0), post-intervention (week 13), follow-up (week 25); Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Transition Readiness Scale
Informant and self-report measure of adolescent transition readiness (education, work, independent living). Self-report scale that ranges from 1 - not true for me/my child to 4 - true for me/my child. Higher scores represent better transition readiness.
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist Control - Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Canadian Occupational Performance Measure (COPM)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist control- Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Transition Planning Inventory - 3rd Edition
A four-section survey about student preferences and interests for post-secondary outcomes. Respondents identify a goal for work, school, or independent living and answer five open-ended questions related to their goal. Qualitative responses will be used to co-create goals for intervention sessions.
Time frame: Baseline (Week 0)
Plan to share: No
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University of Missouri-Columbia