Improving Student Mental Health Through a Universal Trauma-Informed Intervention

NCT07842432 | Not Yet Recruiting DMC

• 2 other identifiers: IRB000360161R01HD119223
• Study Type: interventional
• Target: 960
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety Symptoms; Post-traumatic Stress Symptoms; Depressive Symptoms; Behavioral Problems

Keywords

Trauma-Informed Intervention; Adolescent Mental Health; Implementation Science; School-Based Mental Health; Emotion Regulation; Mindfulness; RAP Club; Hybrid Effectiveness-Implementation Trial; Implementation Fidelity; Intervention Feasibility; Cost-Effectiveness; Project POWER Plus

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (11)

• 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

Other Outcomes (4)

• Change from Baseline in Hope as Measured by the Hope Scale from Child Trends

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

• Change from Baseline in Coping Strategies as Assessed by the Brief Coping Orientation to Problems Experienced (COPE)

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

• Change from Baseline in Positive Youth Development as Assessed by the Short Positive Youth Development Scale

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

Study Arms (4)

Clinician Facilitator + Standard Supervision

EXPERIMENTAL

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

Behavioral: RAP Club Delivered by a School Clinician; Behavioral: Standard Supervision

Clinician Facilitator + Enhanced Supervision

EXPERIMENTAL

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

Behavioral: RAP Club Delivered by a School Clinician; Behavioral: Enhanced Supervision

Teacher + Standard Supervision

EXPERIMENTAL

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

Behavioral: RAP Club Delivered by a Teacher; Behavioral: Standard Supervision

Teacher + Enhanced Supervision

EXPERIMENTAL

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

Behavioral: RAP Club Delivered by a Teacher; Behavioral: Enhanced Supervision

Interventions

RAP Club Delivered by a School Clinician BEHAVIORAL

RAP Club is a 12-session universal group intervention to promote mental health among 8th graders. It is delivered twice weekly over six weeks during the school day. Sessions include mindfulness practices and skills training in emotion regulation, distress tolerance, communication, and problem-solving. School-based mental health providers will be trained to deliver the program.

Clinician Facilitator + Enhanced Supervision; Clinician Facilitator + Standard Supervision

RAP Club Delivered by a Teacher BEHAVIORAL

RAP Club is a 12-session universal group intervention to promote mental health among 8th graders. It is delivered twice weekly over six weeks during the school day. Sessions include mindfulness practices and skills training in emotion regulation, distress tolerance, communication, and problem-solving. Teachers and school staff members without specialized mental health training will be trained to deliver the program.

Teacher + Enhanced Supervision; Teacher + Standard Supervision

Standard Supervision BEHAVIORAL

RAP Club facilitators receive weekly virtual group supervision.

Clinician Facilitator + Standard Supervision; Teacher + Standard Supervision

Enhanced Supervision BEHAVIORAL

RAP Club facilitators receive weekly virtual group supervision plus in-person observation and coaching once per week (i.e., at 6 of the 12 intervention sessions).

Clinician Facilitator + Enhanced Supervision; Teacher + Enhanced Supervision

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Anxiety Disorders; Depression; Problem Behavior; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior; Self-Control; Social Behavior

Study Officials

• Tamar Mendelson

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dahlia Aljuboori, MBChB, MHS

CONTACT

810-336-6737; dahlia.aljuboori@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE