Anxiety SymptomsPPPNCT07842432
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
A study testing RAP Club Delivered by a School Clinician, RAP Club Delivered by a Teacher and Standard Supervision in people with Anxiety Symptoms and Post-traumatic Stress Symptoms, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Symptoms, Post-traumatic Stress Symptoms, Depressive Symptoms
- What is being tested?
- RAP Club Delivered by a School Clinician, RAP Club Delivered by a Teacher and Standard Supervision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Oct 2026to Mar 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Henderson-Hopkins School
Baltimore, Maryland, 21205
- Recruiting
Walter P. Carter Elementary/Middle School
Baltimore, Maryland, 21212
- Recruiting
Francis Scott Key Elementary/Middle School
Baltimore, Maryland, 21230
About this study
Official title: 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
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
- Being tested
- RAP Club Delivered by a School Clinician, RAP Club Delivered by a Teacher, Standard Supervision, Enhanced Supervision
- 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
- Medical subject headings
- Anxiety Disorders, Depression, Problem Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAP Club Delivered by a School ClinicianBehavioural
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 Delivered by a TeacherBehavioural
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.
Standard SupervisionBehavioural
RAP Club facilitators receive weekly virtual group supervision.
Enhanced SupervisionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Clinician Facilitator + Standard Supervision | Experimental | Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives standard supervision. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: RAP Club Delivered by a Teacher; Behavioral: Enhanced Supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
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.
Measured: 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.
Measured: 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.]
Measured: 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.]
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: Up to 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start8 Oct 2026
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Tamar Mendelson, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842432
- Sponsor's protocol ID
- IRB00036016
- Other IDs
- 1R01HD119223
- Acronym
- PPP
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.