Improving Mental Health and School Performance in Urban Eighth Graders

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906682
• Other study ID #: R305A160082-17
• Secondary ID: R01HD090022
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: August 13, 2021

Study information

• Verified date: August 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: August 13, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Disruptive Behavior
• Problem Behavior
• Psychological Trauma
• Trauma, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Institute of Education Sciences (IES)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Academic records	Data on school performance collected by the 8th grade teacher as part of routine school practice.	Past year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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