Metacognitive Strategy Training for Cerebral Palsy

Overseen By Melanie M. Tkach, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Profound intellectual disability, severe mental health, others

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Willingness to participate in all aspects of the proposed study.

I can move around on my own, with or without equipment.

I am 13-17 years old with cerebral palsy and have a caregiver over 18.

Exclusion Criteria

I am a young person with a profound intellectual disability.

I am a young person with a severe mental health condition.

Youth who engage in community-based transition services redundant with remote PREP

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Youth-caregiver dyads complete remote baseline assessments

1 week

1 visit (virtual)

Intervention

Participants receive a 12-week remote PREP intervention or attention control with weekly virtual sessions

12 weeks

12 visits (virtual)

Post-Intervention Assessment

Participants complete outcome measures and optional interviews remotely to capture outcomes and experiences

1 week

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control Condition
• Pathways and Resources for Engagement and Participation

How Is the Trial Designed?

Group I: Remote Metacognitive Strategy Training Experimental Treatment 1 Intervention

Using a structured five-step process, providers guide adolescents and caregivers to set transition goals, identify and implement strategies, and evaluate outcomes.

Group II: Attention Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+