NCT07216196

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026May 2027

First Submitted

Initial submission to the registry

October 9, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 8, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2027

Last Updated

April 28, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

October 9, 2025

Last Update Submit

April 27, 2026

Conditions

Autism

Keywords

Occupational TherapyAutismTransition to AdulthoodWaitlist Crossover

Outcome Measures

Primary Outcomes (2)

  • Acceptability of Intervention Measure (AIM)

    Measure of intervention acceptability. Self-report Likert scale from 1 -completely disagree to 5 - completely agree

    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.

    Intervention - week 13; Waitlist control - week 25

Secondary Outcomes (5)

  • Participation and Environment Measure - Child and Youth

    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

    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

    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

    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)

    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)

Other Outcomes (1)

  • Transition Planning Inventory - 3rd Edition

    Baseline (Week 0)

Study Arms (2)

Remote Metacognitive Strategy Training

EXPERIMENTAL

The intervention group will complete the remote metacognitive strategy training intervention immediately.

Behavioral: Pathways and Resources for Engagement and Participation (PREP)

Waitlist Control

NO INTERVENTION

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.

Interventions

Pathways and Resources for Engagement and Participation (PREP)BEHAVIORAL

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.

Remote Metacognitive Strategy Training

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Autistic adolescents aged 13-21 AND one primary parent, guardian, or caregiver aged 18 or older
  • At least one year remaining in high school
  • Ability to engage in reciprocal conversation
  • Ability to provide informed consent/assent as part of an adapted procedure designed to prevent coercion and protect the rights of autistic adolescents with or without intellectual disability

You may not qualify if:

  • Severe or profound intellectual disability (IQ\<35)
  • Severe mental health conditions that interfere with ability to participate in the intervention
  • Currently enrolled in community-based transition services redundant with remote PREP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65211, United States

RECRUITING

Related Publications (7)

  • Anderson KA, Sosnowy C, Kuo AA, Shattuck PT. Transition of Individuals With Autism to Adulthood: A Review of Qualitative Studies. Pediatrics. 2018 Apr;141(Suppl 4):S318-S327. doi: 10.1542/peds.2016-4300I.

    PMID: 29610413BACKGROUND

  • Snell-Rood C, Ruble L, Kleinert H, McGrew JH, Adams M, Rodgers A, Odom J, Wong WH, Yu Y. Stakeholder perspectives on transition planning, implementation, and outcomes for students with autism spectrum disorder. Autism. 2020 Jul;24(5):1164-1176. doi: 10.1177/1362361319894827. Epub 2020 Jan 20.

    PMID: 31957461BACKGROUND

  • Kang LJ, Huang HH, Wu YT, Chen CL. Initial evaluation of an environment-based intervention for participation of autistic children: a randomized controlled trial. Disabil Rehabil. 2024 May;46(9):1851-1861. doi: 10.1080/09638288.2023.2209743. Epub 2023 May 15.

    PMID: 37183406BACKGROUND

  • Hsieh YH, Ryan M, Anaby D. Towards multi-faceted outcomes of participation-based interventions: mapping the PREP's effects for children and youth with disabilities. Disabil Rehabil. 2024 Oct;46(20):4825-4834. doi: 10.1080/09638288.2023.2280084. Epub 2023 Nov 21.

    PMID: 39319861BACKGROUND

  • Little LM, Cohen SR, Tomchek SD, Baker A, Wallisch A, Dean E. Interventions to Support Social Participation for Autistic Children and Adolescents in Homes and Communities (2013-2021). Am J Occup Ther. 2023 Mar 1;77(Suppl 1):7710393200. doi: 10.5014/ajot.2023.77S10020.

    PMID: 37611261BACKGROUND

  • Baker A, Tomchek SD, Little LM, Wallisch A, Dean E. Interventions to Support Participation in Basic and Instrumental Activities of Daily Living for Autistic Children and Adolescents (2013-2021). Am J Occup Ther. 2023 Mar 1;77(Suppl 1):7710393140. doi: 10.5014/ajot.2023.77S10014.

    PMID: 37562056BACKGROUND

  • Egilson ST, Jakobsdottir G, Olafsson K, Leosdottir T. Community participation and environment of children with and without autism spectrum disorder: parent perspectives. Scand J Occup Ther. 2017 May;24(3):187-196. doi: 10.1080/11038128.2016.1198419. Epub 2016 Jun 22. Erratum In: Scand J Occup Ther. 2017 May;24(3):233. doi: 10.1080/11038128.2017.1262031.

    PMID: 27329683BACKGROUND

Related Links

MeSH Terms

Conditions

Autistic Disorder

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Melanie M. Tkach, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie M. Tkach, PhD

CONTACT

573-882-0992melanie.tkach@health.missouri.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 9, 2025

First Posted

October 14, 2025

Study Start

April 8, 2026

Primary Completion (Estimated)

November 3, 2026

Study Completion (Estimated)

May 3, 2027

Last Updated

April 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)