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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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