Cerebral Palsy (CP)NCT07424079
Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy
A study testing Pathways and Resources for Engagement and Participation in people with Cerebral Palsy (CP), run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Pathways and Resources for Engagement and Participation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 28 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Youth with profound intellectual disability
- Youth with severe mental health conditions
- Youth who engage in community-based transition services redundant with remote PREP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Missouri - Columbia
Columbia, Missouri, 65211
Melanie M. Tkach, PhD, 573-882-0992, melanie.tkach@health.missouri.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Pathways and Resources for Engagement and Participation, Attention Control Condition
- Keywords
- Cerebral Palsy, Occupational Therapy, Adolescents, Caregivers, Transition Planning, Participation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways and Resources for Engagement and ParticipationBehavioural
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 ConditionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
Measure of intervention acceptability. Self-report Likert scale from 1 -completely disagree to 5 - completely agree
Measured: 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.
Measured: Post-Intervention (Week 13) or Attention Control (Week 13)
Secondary outcomes (5)
Participation and Environment Measure - Child and Youth
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.
Measured: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Youth, Young Adult Participation and Environment Measure
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.
Measured: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Transition Readiness Scale
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.
Measured: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Canadian Occupational Performance Measure (COPM)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Measured: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Medical Outcomes Study 36-Item Short Form Survey (SF-36)
Self-report measure of health-related quality of life. Minimum = 0, Maximum = 100. Higher scores mean better health-related quality of life.
Measured: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start31 Aug 2026 (estimated)
- Primary completion16 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Tkach, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424079
- Sponsor's protocol ID
- 2132811
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No