Anxiety Symptoms, Post-traumatic Stress Symptoms, Depressive Symptoms, Behavioral Problems
Conditions
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
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.
Interventions
BEHAVIORALRAP Club Delivered by a School Clinician
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.
BEHAVIORALRAP Club Delivered by a Teacher
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.
BEHAVIORALStandard Supervision
RAP Club facilitators receive weekly virtual group supervision.
BEHAVIORALEnhanced 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).
Sponsors
Johns Hopkins Bloomberg School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post Traumatic Stress Disorder Symptoms as Assessed by the Child PTSD Symptom Scale V (CPSS-V-SR) [Effectiveness outcome] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. \[Note: including this measure to facilitate the calculation of cost effectiveness for improving depression symptoms.\] |
| 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 | 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. \[Note: This is the depression measure was used in the investigators prior research, so it's being retained despite the addition of the PHQ-8.\] |
| Fidelity of Intervention Implementation as Assessed by Observational Coding and Facilitator Ratings [Implementation outcome] | Up to 6 weeks | 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. |
| Fidelity of Intervention Implementation as Assessed by Student Attendance | Up to 6 weeks | The investigators will collect data on student attendance to assess whether the student received an adequate dose of the intervention. |
| Intervention Feasibility as Assessed by the Feasibility of Intervention Measure (FIM) [Implementation outcome] | Post-intervention, approximately 12 months | 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.) |
| Intervention Acceptability as Assessed by the Acceptability of Intervention Measure (AIM) [Implementation outcome] | Post intervention, approximately 12 months | 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.) |
| Intervention Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM) [Implementation outcome] | Post intervention, approximately 12 months | 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.) |
| Implementation Costs for RAP Club Delivery [Implementation outcome] | Facilitator training through intervention completion (6 weeks) | The average cost per student will be calculated for each implementation condition. Costs will include program materials, program training, supervision, coaching, and facilitator time. |
| Intervention Cost-Effectiveness for Reducing Mental Health Problems [Implementation outcome] | Up to 12-month follow up | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTamar Mendelson
Johns Hopkins Bloomberg School of Public Health
Outcome results
None listed