An interventional study of RAP Club Delivered by a School Clinician and RAP Club Delivered by a Teacher in Anxiety Symptoms, Post-traumatic Stress Symptoms and Depressive Symptoms, sponsored by Johns Hopkins Bloomberg School of Public Health. Active, not recruiting at 3 sites in United States. Open to participants aged 12 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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:
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 960 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Students:
School Leaders:
RAP Club Facilitators:
Exclusion Criteria:
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
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
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
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
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.
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.
RAP Club facilitators receive weekly virtual group supervision.
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).
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.
Time frame: Baseline, post-intervention up to 2 weeks, 4-month follow-up, and 12-month follow-up
Change in Anxiety Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Item Bank V3.0 [Effectiveness outcome]
PROMIS Pediatric Anxiety Item Bank V3.0: An 8-item self-report measure of anxiety symptoms to be completed by students. Response options range from 1 to 5, with higher scores indicating more anxiety symptoms.
Time frame: 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]
SDQ Conduct Problems and Hyperactivity/Inattention subscales - Self-report scales assessing conduct problems (5 items) and hyperactivity-inattention (5 items) to be completed by students. Response options range from 0 to 2, with higher scores indicating more conduct problems and hyperactivity/inattention.
Time frame: 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]
PHQ-8: Self-report 8-item measure of depression symptoms to be completed by students. Response options range from 0 to 3, with higher scores indicating more depression symptoms. \[Note: including this measure to facilitate the calculation of cost effectiveness for improving depression symptoms.\]
Time frame: 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]
CDI-SF: A 10-item self-report measure of depression symptoms to be completed by students. Response options range from 0 to 2, with higher scores indicating more depression symptoms. \[Note: This is the depression measure was used in the investigators prior research, so it's being retained despite the addition of the PHQ-8.\]
Time frame: 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]
The extent to which facilitators deliver RAP Club as specified in the curriculum will be assessed through observational coding of intervention sessions by trained study team members and by facilitator self-ratings of fidelity for each session. Assessed at each of the 12 intervention sessions.
Time frame: Up to 6 weeks
Fidelity of Intervention Implementation as Assessed by Student Attendance
The investigators will collect data on student attendance to assess whether the student received an adequate dose of the intervention.
Time frame: Up to 6 weeks
Intervention Feasibility as Assessed by the Feasibility of Intervention Measure (FIM) [Implementation outcome]
FIM: 4-item measure assessing perceived feasibility of an intervention to be completed by program facilitators. Response options range from 1 to 5, with higher scores indicating higher perceived intervention feasibility. (Student focus groups and interviews with principals and facilitators will provide additional data on feasibility.)
Time frame: Post-intervention, approximately 12 months
Intervention Acceptability as Assessed by the Acceptability of Intervention Measure (AIM) [Implementation outcome]
The AIM is 4-item measure assessing acceptability of an intervention, which will be completed by RAP Club facilitators. Response options range from 1 to 5, with higher scores indicating higher perceived intervention acceptability. (Student focus groups and interviews with principals and facilitators will provide additional data on acceptability.)
Time frame: Post intervention, approximately 12 months
Intervention Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM) [Implementation outcome]
IAM: 4-item measure assessing perceptions of whether the intervention is appropriate for the setting, which will be completed by program facilitators. Response options range from 1 to 5, with higher scores indicating higher perceived intervention appropriateness. (Student focus groups and interviews with principals and facilitators will provide additional data on appropriateness.)
Time frame: Post intervention, approximately 12 months
Implementation Costs for RAP Club Delivery [Implementation outcome]
The average cost per student will be calculated for each implementation condition. Costs will include program materials, program training, supervision, coaching, and facilitator time.
Time frame: Facilitator training through intervention completion (6 weeks)
Intervention Cost-Effectiveness for Reducing Mental Health Problems [Implementation outcome]
Using cost data for RAP Club implementation (e.g., program supplies, training, supervision, coaching, facilitator time) and student mental health outcome data such as changes in depression and PTSD symptoms, cost effectiveness will be calculated for each of the four study conditions.
Time frame: Up to 12-month follow up
Change from Baseline in Hope as Measured by the Hope Scale from Child Trends
Students' self-reported hope will be assessed at each study time point using a 3-item self-report measure developed by Child Trends. Response options range from 1 to 5, with higher scores indicating higher levels of hope.
Time frame: 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)
Brief COPE: 28-item self-report measure of coping strategies to be completed by students. Response items range from 1 to 4, with higher scores indicating more frequent usage of coping strategies.
Time frame: 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
Short Positive Youth Development Scale: A 7-item self-report measure of positive youth development to be completed by students. Response options range from 0 to 10, with higher scores indicating higher levels of positive youth development.
Time frame: Baseline, post-intervention up to 2 weeks, 4-month follow up, and 12-month follow up
Change from Baseline in Resilience as Assessed by the Protective Factors for Resilience Scale (PFRS)
PFRS: A 20-item self-report measure of protective factors that support resilience to be completed by students. Responses options range from 1 to 7, with higher scores indicating higher levels of resilience.
Time frame: Baseline, post-intervention up to 2 weeks, 4-month follow up, and 12-month follow up
Plan to share: Yes — De-identified study data will be archived following study completion, as well as data dictionaries and scoring code, so that it is available to other researchers.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2031, 53 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 53 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health →