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

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT07424079
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy (CP)

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Feb 2026
Primary completion
Feb 16, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Acceptability of Intervention Measure (AIM) [ Time Frame: Post-Intervention (Week 13) or Attention Control (Week 13) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri - ColumbiaColumbiaMissouri65211
Melanie M. Tkach, PhD
[email protected]
573-882-0992

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By research site
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