The Feasibility of Remote Pathways and Resources for Engagement and Participation (PREP) for Transition-Age Youth With Cerebral Palsy and Primary Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Youth with profound intellectual disability
- •Youth with severe mental health conditions
- •Youth who engage in community-based transition services redundant with remote PREP
研究组 & 干预措施
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.
干预措施: Attention Control Condition (Behavioral)
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.
干预措施: Pathways and Resources for Engagement and Participation (Behavioral)
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: 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
Semi-Structured Interview
时间窗: 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.
次要结局
- Participation and Environment Measure - Child and Youth(Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13))
- Youth, Young Adult Participation and Environment Measure(Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13))
- Transition Readiness Scale(Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13))
- Canadian Occupational Performance Measure (COPM)(Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13))
- Medical Outcomes Study 36-Item Short Form Survey (SF-36)(Baseline (Week 0); Post-Intervention (Week 13) or Attention Control (Week 13))
研究者
Melanie Tkach
Assistant Professor
University of Missouri-Columbia