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

NCT07424079 | Not Yet Recruiting

• 1 other identifier: 2132811
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral Palsy; Occupational Therapy; Adolescents; Caregivers; Transition Planning; Participation

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

  Post-Intervention (Week 13) or Attention Control (Week 13)

• 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.

  Post-Intervention (Week 13) or Attention Control (Week 13)

Secondary Outcomes (5)

• Participation and Environment Measure - Child and Youth

  Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)

• Youth, Young Adult Participation and Environment Measure

  Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)

• Transition Readiness Scale

  Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)

• Canadian Occupational Performance Measure (COPM)

  Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)

• Medical Outcomes Study 36-Item Short Form Survey (SF-36)

  Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)

Other Outcomes (1)

• Transition Planning Inventory - 3rd Edition Student Preferences and Interests Form

  Baseline (Week 0)

Study Arms (2)

Remote Metacognitive Strategy Training

EXPERIMENTAL

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

Attention Control

PLACEBO COMPARATOR

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

Interventions

Pathways and Resources for Engagement and Participation 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. 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.

Remote Metacognitive Strategy Training

Attention Control Condition BEHAVIORAL

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.

Attention Control

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65211, United States

Location

Related Links

• PREP Intervention Protocol

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Melanie M. Tkach, PhD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)