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临床试验/NCT03906682
NCT03906682已完成不适用

RAP Club: Improving Mental Health and School Performance in Urban Eighth Graders

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 615 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
615
试验地点
2
主要终点
Academic Competence Evaluation Scale (ACES)

研究概览

简要总结

This study assesses: (1) the impact of the Relax, Be Aware, Do a Personal Rating (RAP) Club, a school-based prevention program for urban eighth graders, on students' emotional functioning and education outcomes; (2) potential moderators and mediators of RAP Club's effects; and (3) factors related to the implementation of RAP Club, including cost of delivery and perceptions of key stakeholders.

详细描述

Youth in low-income urban communities are often exposed to chronic stress and trauma, which poses risk for emotional, behavioral, and academic problems. This study will evaluate the impact of RAP Club, a trauma-informed school-based prevention program intended to promote positive emotional and academic development for eighth graders. Participants will be randomly assigned within schools to receive RAP Club or Healthy Topics, a health education active control condition.

The study will achieve the following specific aims:

  1. Test whether students randomized to RAP Club have improved academic, social-emotional, and behavioral outcomes as compared to those randomized to Healthy Topics (e.g., student-reported mood and stress; teacher-rated academic performance; academic record data).
  2. Explore potential moderators (e.g., baseline trauma exposure, emotional regulation) and mediators (e.g., changes in self-regulation and emotional symptoms) of RAP Club's effects.
  3. Evaluate factors related to program implementation, including cost of delivering RAP Club versus Healthy Topics and perceptions of key stakeholders (teachers, group facilitators, students) regarding intervention acceptability and sustainability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Subject is attending eighth grade at a participating Baltimore City Public School
  • Subject is not in a self-contained special education classroom
  • Subject provides written parent permission and written assent

排除标准

  • Non English-speaking

结局指标

主要结局

Academic Competence Evaluation Scale (ACES)

时间窗: Past 6 weeks

10-item teacher report of student academic functioning with 3 subscales (Engagement, Motivation, Academic Performance) that is rated on a 5-point Likert scale. Mean of items 1-9 provides the total score; subscales are calculated by taking the mean of relevant items. Higher scores indicate more academic competence.

Academic records

时间窗: Past year

Data on school performance collected by the 8th grade teacher as part of routine school practice.

Teacher Rating of Social Competence Scale (TRSCS)

时间窗: Past three weeks

31-item teacher-rated scale of student classroom behavior using a 6-point Likert scale. Means are calculated for each subscale (Aggressive Behaviors, Oppositional Behavior, Attention and Concentration, Social and Emotional Competence). Higher scores reflect a higher level of that particular construct.

Strengths and Difficulties Questionnaire (SDQ)

时间窗: Past 6 weeks

Made up of 5 scales (Emotional Symptoms, Conduct Problems, Hyperactivity, Peer Problems, Prosocial Behavior). Several items (7, 21, 25, 11, and 14) are reverse coded. Total difficulties score is created by summing scores from all scales except the prosocial scale. The score ranges from 0-40 and is counted as missing if one of the 4 component scores is missing.

次要结局

  • Child PTSD Symptom Scale Revised (CPSSR)(Past 2 weeks)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms(Past 7 days)
  • Brief Cope(Past 6 weeks)
  • Youth Outcome Questionnaire Self-Report (YOQSR)(Past week)
  • Children's Response Style Questionnaire (CRSQ)(Past 6 weeks)
  • Children's Depression Inventory - Short Form (CDI-S)(Past 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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