Improving Mental Health and School Performance in Urban Eighth Graders

NCT03906682 | Completed DMC

• 2 other identifiers: R305A160082-17R01HD090022
• Study Type: interventional
• Target: 615
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms; Trauma, Psychological; Disruptive Behavior

Keywords

prevention; urban youth; mindfulness

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Child PTSD Symptom Scale Revised (CPSSR)

  Past 2 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms

  Past 7 days

• Children's Depression Inventory - Short Form (CDI-S)

  Past 2 weeks

• Youth Outcome Questionnaire Self-Report (YOQSR)

  Past week

• Brief Cope

  Past 6 weeks

Study Arms (2)

RAP Club program

EXPERIMENTAL

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

Healthy Topics program

ACTIVE COMPARATOR

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

Interventions

RAP Club BEHAVIORAL

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.

RAP Club program

Healthy Topics BEHAVIORAL

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.

Healthy Topics program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non English-speaking

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Institute of Education Sciences: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Depression; Psychological Trauma; Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Child Behavior

Study Officials

• Tamar Mendelson, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: April 8, 2019
• Study Start: July 1, 2016
• Primary Completion: May 30, 2020
• Study Completion: August 13, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After initial data analysis and preparation of major publications have been completed.
• Access Criteria: Data files placed in the data hosting service are open access and freely available to the research community.

Locations

US (1)