Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy

April 27, 2026 updated by: Melanie Tkach, University of Missouri-Columbia

The Feasibility of Remote Pathways and Resources for Engagement and Participation (PREP) for Transition-Age Youth With Cerebral Palsy and Primary Caregivers

This exploratory randomized controlled trial will examine the feasibility and preliminary effects of a remote PREP intervention compared to an attention control for transition-age youth with cerebral palsy and their caregivers. Youth-caregiver dyads will complete remote baseline assessments and be randomized to a 12-week intervention or attention control, with weekly virtual sessions. Feasibility outcomes will be primary, with secondary outcomes exploring preliminary efficacy. Post-intervention assessments and optional interviews will be conducted remotely to capture outcomes and participant experiences.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The proposed clinical trial is a single-blind, parallel, exploratory, randomized controlled trial to test the feasibility and effect of remote Pathways and Resources for Engagement and Participation (PREP) compared to attention control for transition-age youth with Cerebral Palsy (CP) and a primary caregiver (i.e., youth-caregiver dyads). Primary outcomes evaluate feasibility of research and intervention protocols, while secondary outcomes allow limited efficacy testing consistent with established feasibility study guidelines. Eligible youth-caregiver dyads will complete a remote baseline assessment session and be randomized to (1) a 12-session remote PREP intervention or (2) a 12-session attention control group. The intervention group will complete one 60-minute session per week for 12 weeks, while the attention control group will meet virtually with the research team once per week for the same duration. Youth-caregiver dyads will complete outcome measures again remotely after the 12-week timeframe. The research team will also invite youths and caregivers to complete a semi-structured interview following PREP or attention control sessions.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Youth aged 13 -17 with CP and one primary parent, guardian, or caregiver aged 18 or older
  • Youth ability to self-mobilize with or without adaptive equipment measured by the Gross Motor Function Scale-Expanded & Revised (GMFCS-E&R) Levels I - III
  • Effective youth communication measured by Communication Function Classification System (CFCS) Levels I - III
  • Ability to read, speak, and write English
  • Willingness to participate in all aspects of the proposed study.

Exclusion Criteria:

  • Youth with profound intellectual disability
  • Youth with severe mental health conditions
  • Youth who engage in community-based transition services redundant with remote PREP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote Metacognitive Strategy Training
Using a structured five-step process, providers guide adolescents and caregivers to set transition goals, identify and implement strategies, and evaluate outcomes.
Behavioral: Pathways and Resources for Engagement and Participation
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. The provider and family 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.
Placebo Comparator: Attention Control
Youth-caregiver dyads in the attention control group will have weekly virtual sessions focused on supportive interaction and access to a CP resource, without additional instruction. Sessions will be monitored for content, duration, and fidelity.
Behavioral: Attention Control Condition
Youth-caregiver dyads in the attention control group will have dose-equivalent, weekly virtual contact with a research team member who is not involved in remote PREP delivery. The attention control condition will control for interpersonal interaction, maturation, and testing effects. The focus of each session will be (1) social interaction characterized by warmth/empathy and (2) access to The Adult CP Toolkit: Navigating Life with Cerebral Palsy, which is publicly available. The research team member will answer questions but will not provide further education or instruction and will also check-in with the youth-caregiver dyad on any functional changes or transition progress. The research team will track the content and duration of each call and record each session with two randomly reviewed for fidelity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention Measure (AIM)
Time Frame: Post-Intervention (Week 13) or Attention Control (Week 13)
Measure of intervention acceptability. Self-report Likert scale from 1 -completely disagree to 5 - completely agree
Post-Intervention (Week 13) or Attention Control (Week 13)
Semi-Structured Interview
Time Frame: Post-Intervention (Week 13) or Attention Control (Week 13)
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.
Post-Intervention (Week 13) or Attention Control (Week 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation and Environment Measure - Child and Youth
Time Frame: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
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.
Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Youth, Young Adult Participation and Environment Measure
Time Frame: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
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.
Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Transition Readiness Scale
Time Frame: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
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.
Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Medical Outcomes Study 36-Item Short Form Survey (SF-36)
Time Frame: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Self-report measure of health-related quality of life. Minimum = 0, Maximum = 100. Higher scores mean better health-related quality of life.
Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition Planning Inventory - 3rd Edition Student Preferences and Interests Form
Time Frame: Baseline (Week 0)
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.
Baseline (Week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

February 16, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2132811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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