跳至主要内容
临床试验/NCT07842432
NCT07842432尚未招募不适用

Improving Student Mental Health Through a Universal Trauma-Informed Intervention: Testing Effectiveness and Implementation of Relax, be Aware, and do a Personal Rating (RAP) Club

Johns Hopkins Bloomberg School of Public Health0 个研究点目标入组 960 人开始时间: 2026年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
960
主要终点
Change in Post Traumatic Stress Disorder Symptoms as Assessed by the Child PTSD Symptom Scale V (CPSS-V-SR) [Effectiveness outcome]

研究概览

简要总结

The goal of this trial is to identify the most effective ways for schools to deliver RAP Club, a universal school-based mental health intervention. RAP Club is an evidence-based group program designed to help 8th grade students manage stress, regulate emotions, and make healthy decisions. This study investigates two factors related to program implementation: type of program facilitator (teacher vs. school-based clinician) and level of facilitator supervision (standard vs. enhanced). The investigators will test four conditions that represent all combinations of these two factors. The main questions this study aims to answer are:

  • Which combination of facilitator type and supervision level is most effective for improving student mental health?
  • How much does each of the four conditions cost, and how cost-effective, practical, and acceptable is each?

The investigators will work with 32 public schools. Each school will deliver two RAP Club groups with approximately 15 students per group. One group will be led by a school clinician and the other by a teacher. One of these facilitators will be randomized to receive weekly group supervision and the other to receive enhanced supervision, which also includes observation and coaching. The investigators will collect survey data on student mental health at baseline, after RAP Club, at 4-month follow-up, and at 12-month follow up when students are in 9th grade. The investigators will also collect academic data, program delivery data (e.g., attendance), and feedback from students, facilitators, and principals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Eighth-grade students enrolled in a participating Baltimore City Public School who are not in a self-contained special education classroom
  • •School Leaders:
  • •Principals or vice principals from participating schools
  • •RAP Club Facilitators:
  • •School-based mental health providers or school staff members who deliver RAP Club at a participating school

排除标准

  • •Students in self-contained special education classrooms are not eligible for participation because RAP Club has not been tailored to students in self-contained special education learning needs.
  • •Students in foster care are not eligible for participation unless and until the study receives approval from the Social Services Administration for participation.

研究组 & 干预措施

Clinician Facilitator + Standard Supervision

Experimental

Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives standard supervision.

干预措施: RAP Club Delivered by a School Clinician (Behavioral)

Clinician Facilitator + Standard Supervision

Experimental

Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives standard supervision.

干预措施: Standard Supervision (Behavioral)

Clinician Facilitator + Enhanced Supervision

Experimental

Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives enhanced supervision.

干预措施: RAP Club Delivered by a School Clinician (Behavioral)

Clinician Facilitator + Enhanced Supervision

Experimental

Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives enhanced supervision.

干预措施: Enhanced Supervision (Behavioral)

Teacher + Standard Supervision

Experimental

Students participate in the RAP Club intervention delivered by a teacher or staff member who receives standard supervision.

干预措施: RAP Club Delivered by a Teacher (Behavioral)

Teacher + Standard Supervision

Experimental

Students participate in the RAP Club intervention delivered by a teacher or staff member who receives standard supervision.

干预措施: Standard Supervision (Behavioral)

Teacher + Enhanced Supervision

Experimental

Students participate in the RAP Club intervention delivered by a teacher who receives enhanced supervision.

干预措施: RAP Club Delivered by a Teacher (Behavioral)

Teacher + Enhanced Supervision

Experimental

Students participate in the RAP Club intervention delivered by a teacher who receives enhanced supervision.

干预措施: Enhanced Supervision (Behavioral)

结局指标

主要结局

Change in Post Traumatic Stress Disorder Symptoms as Assessed by the Child PTSD Symptom Scale V (CPSS-V-SR) [Effectiveness outcome]

时间窗: Baseline, post-intervention up to 2 weeks, 4-month follow-up, and 12-month follow-up

CPSS-V-SR: 21-item self-report measure of PTSD symptoms to be completed by students. Response options range from 0 to 4, with higher scores indicating higher symptom levels.

次要结局

  • Change in Anxiety Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Item Bank V3.0 [Effectiveness outcome](Baseline, post intervention up to 2 weeks, 4-month follow-up, and 12-month follow-up)
  • Change in Behavior Problems as Assessed by the Strengths and Difficulties Questionnaire (SDQ) subscales for conduct problems and hyperactivity/inattention [Effectiveness outcome](Baseline, post-intervention up to 2 weeks, 4-month follow-up, and 12-month follow-up)
  • Change in Depression Symptoms as Assessed by the Patient Health Questionnaire - 8 (PHQ-8) [Effectiveness outcome](Baseline, post-intervention up to 2 weeks, 4-month follow up, and 12-month follow up)
  • Change in Depression Symptoms as Assessed by the Children's Depression Inventory - Short Form (CDI-SF) [Effectiveness outcome](Baseline, post-intervention up to 2 weeks, 4-month follow-up, and 12-month follow-up)
  • Fidelity of Intervention Implementation as Assessed by Observational Coding and Facilitator Ratings [Implementation outcome](Up to 6 weeks)
  • Fidelity of Intervention Implementation as Assessed by Student Attendance(Up to 6 weeks)
  • Intervention Feasibility as Assessed by the Feasibility of Intervention Measure (FIM) [Implementation outcome](Post-intervention, approximately 12 months)
  • Intervention Acceptability as Assessed by the Acceptability of Intervention Measure (AIM) [Implementation outcome](Post intervention, approximately 12 months)
  • Intervention Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM) [Implementation outcome](Post intervention, approximately 12 months)
  • Implementation Costs for RAP Club Delivery [Implementation outcome](Facilitator training through intervention completion (6 weeks))
  • Intervention Cost-Effectiveness for Reducing Mental Health Problems [Implementation outcome](Up to 12-month follow up)

研究者

申办方类型
Other
责任方
Sponsor

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