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

Официальное название

The Feasibility of Remote Pathways and Resources for Engagement and Participation (PREP) for Transition-Age Youth With Cerebral Palsy and Primary Caregivers

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 me

Первичные конечные точки

• Acceptability of Intervention Measure (AIM) [Срок оценки: Post-Intervention (Week 13) or Attention Control (Week 13)]
• Semi-Structured Interview [Срок оценки: Post-Intervention (Week 13) or Attention Control (Week 13)]

Вторичные конечные точки (5)

• Participation and Environment Measure - Child and Youth [Срок оценки: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)]
• Youth, Young Adult Participation and Environment Measure [Срок оценки: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)]
• Transition Readiness Scale [Срок оценки: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)]
• Medical Outcomes Study 36-Item Short Form Survey (SF-36) [Срок оценки: Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Youth with profound intellectual disability
• Youth with severe mental health conditions
• Youth who engage in community-based transition services redundant with remote PREP

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Missouri - Columbia — Columbia

Идентификаторы

NCT: NCT07424079 · 2132811

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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