[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657668":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":70,"studyPopulation":70,"armGroups":76,"interventions":98,"overallOfficials":116,"centralContacts":120,"locations":70,"responsibleParty":126,"collaborators":128,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":70,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":169,"whyStopped":70,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":70},{"fullName":5,"class":6},"Johns Hopkins Bloomberg School of Public Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,21,25,28,32,35,39,43,46,50],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline, post intervention up to 2 weeks, 4-month follow-up, and 12-month follow-up",{"measure":19,"description":20,"timeFrame":12},"Change in Behavior Problems as Assessed by the Strengths and Difficulties Questionnaire (SDQ) subscales for conduct problems and hyperactivity\u002Finattention [Effectiveness outcome]","SDQ Conduct Problems and Hyperactivity\u002FInattention 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\u002Finattention.",{"measure":22,"description":23,"timeFrame":24},"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.\\]","Baseline, post-intervention up to 2 weeks, 4-month follow up, and 12-month follow up",{"measure":26,"description":27,"timeFrame":12},"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.\\]",{"measure":29,"description":30,"timeFrame":31},"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.","Up to 6 weeks",{"measure":33,"description":34,"timeFrame":31},"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.",{"measure":36,"description":37,"timeFrame":38},"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.)","Post-intervention, approximately 12 months",{"measure":40,"description":41,"timeFrame":42},"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.)","Post intervention, approximately 12 months",{"measure":44,"description":45,"timeFrame":42},"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.)",{"measure":47,"description":48,"timeFrame":49},"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.","Facilitator training through intervention completion (6 weeks)",{"measure":51,"description":52,"timeFrame":53},"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.","Up to 12-month follow up",[55,58,61,64],{"measure":56,"description":57,"timeFrame":12},"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.",{"measure":59,"description":60,"timeFrame":12},"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.",{"measure":62,"description":63,"timeFrame":24},"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.",{"measure":65,"description":66,"timeFrame":24},"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.",{"allocation":68,"interventionModel":69,"interventionModelDescription":70,"primaryPurpose":71,"observationalModel":70,"timePerspective":70,"maskingInfo":72},"RANDOMIZED","FACTORIAL",null,"PREVENTION",{"masking":73,"maskingDescription":70,"whoMasked":74},"SINGLE",[75],"OUTCOMES_ASSESSOR",[77,84,89,94],{"label":78,"type":79,"description":80,"interventionNames":81},"Clinician Facilitator + Standard Supervision","EXPERIMENTAL","Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives standard supervision.",[82,83],"Behavioral: RAP Club Delivered by a School Clinician","Behavioral: Standard Supervision",{"label":85,"type":79,"description":86,"interventionNames":87},"Clinician Facilitator + Enhanced Supervision","Students participate in the RAP Club intervention delivered by a school-based mental health provider who receives enhanced supervision.",[82,88],"Behavioral: Enhanced Supervision",{"label":90,"type":79,"description":91,"interventionNames":92},"Teacher + Standard Supervision","Students participate in the RAP Club intervention delivered by a teacher or staff member who receives standard supervision.",[93,83],"Behavioral: RAP Club Delivered by a Teacher",{"label":95,"type":79,"description":96,"interventionNames":97},"Teacher + Enhanced Supervision","Students participate in the RAP Club intervention delivered by a teacher who receives enhanced supervision.",[93,88],[99,104,108,112],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":70},"BEHAVIORAL","RAP 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.",[85,78],{"type":100,"name":105,"description":106,"armGroupLabels":107,"otherNames":70},"RAP 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.",[95,90],{"type":100,"name":109,"description":110,"armGroupLabels":111,"otherNames":70},"Standard Supervision","RAP Club facilitators receive weekly virtual group supervision.",[78,90],{"type":100,"name":113,"description":114,"armGroupLabels":115,"otherNames":70},"Enhanced 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).",[85,95],[117],{"name":118,"affiliation":5,"role":119},"Tamar Mendelson","PRINCIPAL_INVESTIGATOR",[121],{"name":122,"role":123,"phone":124,"phoneExt":70,"email":125},"Dahlia Aljuboori, MBChB, MHS","CONTACT","810-336-6737","dahlia.aljuboori@jhmi.edu",{"type":127,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR",[129],{"name":130,"class":131},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100657668","improving-student-mental-health-through-a-universal-trauma-informed-intervention-100657668",false,"NCT07842432","Improving Student Mental Health Through a Universal Trauma-Informed Intervention","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","PPP","Inclusion Criteria:\n\n1. Students:\n\n   * Eighth-grade students enrolled in a participating Baltimore City Public School who are not in a self-contained special education classroom\n2. School Leaders:\n\n   * Principals or vice principals from participating schools\n3. RAP Club Facilitators:\n\n   * School-based mental health providers or school staff members who deliver RAP Club at a participating school\n\nExclusion Criteria:\n\n* 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.\n* Students in foster care are not eligible for participation unless and until the study receives approval from the Social Services Administration for participation.",true,"ALL","12 Years","15 Years",{"count":145,"type":146},960,"ESTIMATED","INTERVENTIONAL",[149],"NA","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:\n\n* Which combination of facilitator type and supervision level is most effective for improving student mental health?\n* How much does each of the four conditions cost, and how cost-effective, practical, and acceptable is each?\n\nThe 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.",[152,153,154,155],"Anxiety Symptoms","Post-traumatic Stress Symptoms","Depressive Symptoms","Behavioral Problems",[157,158,159,160,161,162,163,164,165,166,167,168],"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","NOT_YET_RECRUITING","2026-09-21",{"date":172,"type":173},"2026-09-25","ACTUAL",{"date":175,"type":146},"2026-10-15",{"date":177,"type":146},"2031-03",{"name":5,"class":6}]