Improving Mental Health and School Performance in Urban Eighth Graders

NCT03906682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2022-08-25

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Institute of Education Sciences

    collaborator FED
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Tamar Mendelson, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2020-05-30
Completion
2021-08-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906682 on ClinicalTrials.gov