Metacognitive Strategy Training for Cerebral Palsy

MM
JE
Overseen ByJuliana Earwood, OTD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Missouri-Columbia

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a remote program designed to help teens with cerebral palsy and their caregivers set and achieve life goals. It tests a strategy-based approach called "Pathways and Resources for Engagement and Participation" against a supportive interaction program to determine which better enhances planning and participation skills. Teens who can move independently, use communication tools effectively, and are willing to join weekly virtual sessions may be ideal candidates. The study primarily examines the program's feasibility and its initial effects on participants. All assessments and interviews occur online, ensuring accessibility from home. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve life planning and participation skills for teens with cerebral palsy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this metacognitive strategy training is safe for transition-age youth with cerebral palsy?

Research has shown that the Pathways and Resources for Engagement and Participation (PREP) program is generally safe and well-tolerated. Past studies did not report any serious side effects. This program helps people set goals and find ways to be more active in their daily lives. Since it offers guidance and support instead of medication, it usually carries a low risk of side effects. Participants in previous studies completed the program without major problems, indicating it is a safe choice for those considering joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Metacognitive Strategy Training for Cerebral Palsy because it offers a novel approach to supporting adolescents with CP during their transition to adulthood. Unlike traditional therapies that might focus on physical rehabilitation or medication management, this strategy emphasizes cognitive and behavioral skills. The treatment guides adolescents and their caregivers through a structured five-step process to set goals, identify strategies, and assess outcomes, empowering them to actively participate in their own development. This personalized, goal-oriented approach is what sets it apart from standard care options, which often don't involve such in-depth personal engagement and strategy development.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

Research has shown that the Pathways and Resources for Engagement and Participation (PREP) program, which participants in this trial may receive, helps teenagers with cerebral palsy engage more in activities. This program aids young people in reaching their goals by modifying their environments and providing guidance. One study found that participants maintained their performance levels and even improved their ability to perform daily tasks, as measured by the COPM scale. Another study discovered that PREP increases participation in community activities, which is crucial for recovery. These findings suggest that PREP positively impacts the lives of young people with cerebral palsy by enhancing their involvement in activities they enjoy.16789

Are You a Good Fit for This Trial?

This trial is for youth aged 13-17 with cerebral palsy who can move around (with or without equipment) and communicate effectively, along with a parent or caregiver. Both must speak English and be willing to participate. Youth cannot join if they have severe intellectual disabilities, serious mental health issues, or are already in similar transition programs.

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.
See 2 more

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

Trial Overview

The study compares a remote metacognitive strategy training program called PREP to an attention control group over 12 weeks. Participants are randomly assigned and meet weekly online to see if the intervention helps youth with cerebral palsy during their transition years.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Remote Metacognitive Strategy TrainingExperimental Treatment1 Intervention
Group II: Attention ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Citations

The effectiveness of the Pathways and Resources for ...

Levels of performance were maintained during follow-up with an additional increase of 0.66 points on the COPM scale (t=3.04, p=0.004).

improving participation of adolescents with physical ...

This study examined the effectiveness of the Pathways and Resources for Engagement and Participation (PREP) intervention in improving the participation of ...

The effectiveness of the Pathways ...

Participation of children and adolescents in community- based activities is an important outcome of rehabilitation interventions, and a research ...

Enhancing Youth Participation Using the PREP Intervention

Pathways and Resources for Engagement and Participation (PREP), an innovative intervention aimed at modifying the environment and coaching youth ...

improving participation of adolescents with physical ...

This study examined the effectiveness of the Pathways and Resources for Engagement and Participation (PREP) intervention in improving the participation of ...

Changes in Overall Participation Profile of Youth with Physical ...

The Pathways and Resources for Engagement and Participation (PREP), an environmental-based intervention, is effective in improving the ...

Full article: A stakeholder-involved adaptation of pathways ...

Pathways and Resources for Engagement and Participation (PREP) is an intervention to optimise individuals' participation by building problem- ...

The Effectiveness of Participation-focused Interventions on ...

Pathways and Resources for Engagement and Participation. What is the study measuring? Primary Outcome Measures. Outcome Measure, Measure Description, Time Frame ...

Effectiveness of Rehabilitation Interventions on ...

This systematic review and meta-analysis indicates that rehabilitation interventions are associated with substantial pre–post improvements in ...