Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-15
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eighth-grade students enrolled in a participating Baltimore City Public School who are not in a self-contained special education classroom
Principals or vice principals from participating schools
School-based mental health providers or school staff members who deliver RAP Club at a participating school
Disqualifiers
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 design
Design model
Factorial
Treatments tested in this trial
RAP Club Delivered by a School Clinician
BehavioralRAP 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 Teacher
BehavioralRAP 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 Supervision
BehavioralRAP Club facilitators receive weekly virtual group supervision.
Enhanced Supervision
BehavioralRAP 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).
Treatment groups
960 Participants
are divided into 4 treatment groupsGroup A: Clinician Facilitator + Standard SupervisionExperimental treatment 2 interventions
Group B: Clinician Facilitator + Enhanced SupervisionExperimental treatment 2 interventions
Group C: Teacher + Standard SupervisionExperimental treatment 2 interventions
Group D: Teacher + Enhanced SupervisionExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline, post-intervention up to 2 weeks, 4-month follow-up, and 12-month follow-upSecondary outcomes
1
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-up2
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-up3
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 up4
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-upOther outcomes
1
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-up2
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-up3
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 up4
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 upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
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