The Feasibility of a Remote Problem-Solving Intervention for Autistic Adolescents or Young Adults and a Caregiver

NCT ID: NCT07216196

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2027-05-03

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.

Detailed Description

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.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remote Metacognitive Strategy Training

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

Group Type: EXPERIMENTAL

Pathways and Resources for Engagement and Participation (PREP)

Intervention Type: 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.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pathways and Resources for Engagement and Participation (PREP)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Melanie Tkach

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie M. Tkach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri - Columbia

Columbia, Missouri, United States

Countries

United States

Central Contacts

Melanie M. Tkach, PhD

Role: CONTACT

melanie.tkach@health.missouri.edu

573-882-0992

Facility Contacts

Melanie M. Tkach, PhD

Role: primary

melanie.tkach@health.missouri.edu

573-882-0992

References

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Reference Type: BACKGROUND

PMID: 29610413 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7311242 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 37183406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39319861 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 37611261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37562056 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27329683 (View on PubMed)

Related Links

https://canchild.ca/shop/25-prep-intervention-protocol/

PREP Intervention Protocol

Other Identifiers

2126948

Identifier Type: -

Identifier Source: org_study_id