Improving Mental Health and School Performance in Urban Eighth Graders
Primary Purpose
Depressive Symptoms, Trauma, Psychological, Disruptive Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RAP Club
Healthy Topics
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Symptoms focused on measuring prevention, urban youth, mindfulness
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Bloomberg School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RAP Club program
Healthy Topics program
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Academic records
Data on school performance collected by the 8th grade teacher as part of routine school practice.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03906682
First Posted
November 14, 2018
Last Updated
August 23, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Institute of Education Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03906682
Brief Title
Improving Mental Health and School Performance in Urban Eighth Graders
Official Title
RAP Club: Improving Mental Health and School Performance in Urban Eighth Graders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
August 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Institute of Education Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Trauma, Psychological, Disruptive Behavior
Keywords
prevention, urban youth, mindfulness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RAP Club program
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Topics program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
RAP Club
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Topics
Intervention Description
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 Outcome Measure Information:
Title
Teacher Rating of Social Competence Scale (TRSCS)
Description
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.
Time Frame
Past three weeks
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
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.
Time Frame
Past 6 weeks
Title
Academic Competence Evaluation Scale (ACES)
Description
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.
Time Frame
Past 6 weeks
Title
Academic records
Description
Data on school performance collected by the 8th grade teacher as part of routine school practice.
Time Frame
Past year
Secondary Outcome Measure Information:
Title
Child PTSD Symptom Scale Revised (CPSSR)
Description
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.
Time Frame
Past 2 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms
Description
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.
Time Frame
Past 7 days
Title
Children's Depression Inventory - Short Form (CDI-S)
Description
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.
Time Frame
Past 2 weeks
Title
Youth Outcome Questionnaire Self-Report (YOQSR)
Description
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.
Time Frame
Past week
Title
Brief Cope
Description
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.
Time Frame
Past 6 weeks
Title
Children's Response Style Questionnaire (CRSQ)
Description
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.
Time Frame
Past 6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamar Mendelson, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.icpsr.umich.edu/web/pages/
Learn more about this trial
Improving Mental Health and School Performance in Urban Eighth Graders
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