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Completed

NCT Number: NCT03906682

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Child Behavior Depression Disruptive Behavior Mental Disorders Problem Behavior Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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:

  • 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).
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Teacher Rating of Social Competence Scale (TRSCS)

    Time frame: Past three weeks

    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.

  2. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Past 6 weeks

    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.

  3. Academic Competence Evaluation Scale (ACES)

    Time frame: Past 6 weeks

    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.

  4. Academic records

    Time frame: Past year

    Data on school performance collected by the 8th grade teacher as part of routine school practice.

Secondary outcomes

  1. Child PTSD Symptom Scale Revised (CPSSR)

    Time frame: Past 2 weeks

    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.

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

    Time frame: Past 7 days

    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.

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

    Time frame: Past 2 weeks

    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.

  4. Youth Outcome Questionnaire Self-Report (YOQSR)

    Time frame: Past week

    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.

  5. Brief Cope

    Time frame: Past 6 weeks

    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.

  6. Children's Response Style Questionnaire (CRSQ)

    Time frame: Past 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Institute of Education Sciences

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 8, 2019
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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