Improving Mental Health and School Performance in Urban Eighth Graders

RAP Club: Improving Mental Health and School Performance in Urban Eighth Graders

This study assesses: (1) the impact of the Relax, Be Aware, Do a Personal Rating (RAP) Club, a school-based prevention program for urban eighth graders, on students' emotional functioning and education outcomes; (2) potential moderators and mediators of RAP Club's effects; and (3) factors related to the implementation of RAP Club, including cost of delivery and perceptions of key stakeholders.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Trauma, Psychological; Disruptive Behavior
• Intervention / Treatment: Behavioral: RAP Club; Behavioral: Healthy Topics

Detailed Description

Youth in low-income urban communities are often exposed to chronic stress and trauma, which poses risk for emotional, behavioral, and academic problems. This study will evaluate the impact of RAP Club, a trauma-informed school-based prevention program intended to promote positive emotional and academic development for eighth graders. Participants will be randomly assigned within schools to receive RAP Club or Healthy Topics, a health education active control condition.

The study will achieve the following specific aims:

1. Test whether students randomized to RAP Club have improved academic, social-emotional, and behavioral outcomes as compared to those randomized to Healthy Topics (e.g., student-reported mood and stress; teacher-rated academic performance; academic record data).
2. Explore potential moderators (e.g., baseline trauma exposure, emotional regulation) and mediators (e.g., changes in self-regulation and emotional symptoms) of RAP Club's effects.
3. Evaluate factors related to program implementation, including cost of delivering RAP Club versus Healthy Topics and perceptions of key stakeholders (teachers, group facilitators, students) regarding intervention acceptability and sustainability.

• Study Type: Interventional
• Enrollment (Actual): 615
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is attending eighth grade at a participating Baltimore City Public School
• Subject is not in a self-contained special education classroom
• Subject provides written parent permission and written assent

Exclusion Criteria:

• Non English-speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAP Club program; RAP Club is a 12-session universal prevention program delivered twice per week over six weeks during the school day. The program is delivered by a trained facilitator and young adult community member.	Behavioral: RAP Club; RAP Club was adapted from a trauma treatment program called Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS). Core program components include psychoeducation, mindfulness, and cognitive-behavioral strategies.
Active Comparator: Healthy Topics program; Like RAP Club, Healthy Topics is a 12-session program delivered twice per week over six weeks during the school day. The program is delivered by a trained facilitator and young adult community member.	Behavioral: Healthy Topics; Co-investigator Dr. Sibinga developed the Healthy Topics curriculum to function as an active control condition for randomized controlled trials in both clinic-based and school-based studies of mindfulness instruction for urban youth. Adapted from the Glencoe Health Curriculum (McGraw Hill), it was designed to control for the effects of a positive adult, time and attention, a small group learning environment, engaged instruction, and interesting material. The Healthy Topics curriculum has been successfully implemented as an effective active control condition, with student engagement and participation comparable to the intervention arm. The curriculum includes information about nutrition, exercise, sleep, drug use, and other topics related to physical health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teacher Rating of Social Competence Scale (TRSCS)	31-item teacher-rated scale of student classroom behavior using a 6-point Likert scale. Means are calculated for each subscale (Aggressive Behaviors, Oppositional Behavior, Attention and Concentration, Social and Emotional Competence). Higher scores reflect a higher level of that particular construct.	Past three weeks
Strengths and Difficulties Questionnaire (SDQ)	Made up of 5 scales (Emotional Symptoms, Conduct Problems, Hyperactivity, Peer Problems, Prosocial Behavior). Several items (7, 21, 25, 11, and 14) are reverse coded. Total difficulties score is created by summing scores from all scales except the prosocial scale. The score ranges from 0-40 and is counted as missing if one of the 4 component scores is missing.	Past 6 weeks
Academic Competence Evaluation Scale (ACES)	10-item teacher report of student academic functioning with 3 subscales (Engagement, Motivation, Academic Performance) that is rated on a 5-point Likert scale. Mean of items 1-9 provides the total score; subscales are calculated by taking the mean of relevant items. Higher scores indicate more academic competence.	Past 6 weeks
Academic records	Data on school performance collected by the 8th grade teacher as part of routine school practice.	Past year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child PTSD Symptom Scale Revised (CPSSR)	17-item self-report measure of trauma symptoms using a 4-point Likert scale. Items are summed to produce a total score. Higher scores indicate more trauma symptoms.	Past 2 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms	4-item self-report measure of anxiety symptoms using a 5-point Likert scale. Items are summed and then converted to standardized t score. Higher scores reflect higher frequency of anxiety symptoms.	Past 7 days
Children's Depression Inventory - Short Form (CDI-S)	10-item self-report measure of depressive symptoms using a 5-point Likert scale. Items are summed to create a score ranging from 0-20; cutoffs can be used to determine depression severity. Higher scores reflect greater frequency of depression symptoms.	Past 2 weeks
Youth Outcome Questionnaire Self-Report (YOQSR)	64-item measure of youth psychological symptoms using a 5-point Likert scale. Items are summed to produce a total score, with higher scores indicating more psychological symptoms.	Past week
Brief Cope	28-item self-report measure of coping using a 4-point Likert scale. We intend to score this measure by using factor analysis to identify sub scales. In previous research, we have identified an adaptive subscale and maladaptive sub scale using this method. Higher scores indicate greater frequency of using a particular coping method.	Past 6 weeks
Children's Response Style Questionnaire (CRSQ)	14-item self-report measure of rumination using a 4-point Likert scale. Mean score is calculated excluding item 14. Higher scores reflect greater tendency to engage in a ruminative response style.	Past 6 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Institute of Education Sciences
• Investigators: Principal Investigator: Tamar Mendelson, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: prevention; mindfulness; urban youth
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Problem Behavior; Psychological Trauma
• Other Study ID Numbers: R305A160082-17; R01HD090022 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The final study data will be computerized datasets that include demographic, behavioral, and emotional information. Data will be redacted to strip all subject identifiers. Datasets will be archived with The Inter-University Consortium for Political and Social Research (ICPSR) at the Institute for Social Research.

ICPSR will provide: (1) data preparation tasks, which include reviewing data for confidentiality and usability, creation of a metadata record, generation of multiple data formats for dissemination and preservation, as well as assignment of a Digital Object Identifier (DOI); and (2) documentation to accompany the quantitative data including codebooks, variable and value labels for two quantitative data files containing up to 200 variables.

A copy of the qualitative data with all identifying information redacted will be placed in ICPSR's data hosting service (openICPSR.org). A digital object identifier (DOI) will be issued for the files from this project.

• IPD Sharing Time Frame: After initial data analysis and preparation of major publications have been completed.
• IPD Sharing Access Criteria: Data files placed in the data hosting service are open access and freely available to the research community.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No