Depressive SymptomsNCT03906682
Improving Mental Health and School Performance in Urban Eighth Graders
A study testing RAP Club and Healthy Topics in people with Depressive Symptoms and Trauma, Psychological, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Trauma, Psychological, Disruptive Behavior
- What is being tested?
- RAP Club and Healthy Topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 13 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: RAP Club: 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.
Read the 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.
- Being tested
- RAP Club, Healthy Topics
- Keywords
- prevention, urban youth, mindfulness
- Medical subject headings
- Depression, Psychological Trauma, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAP ClubBehavioural
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 TopicsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Past 6 weeks
Academic records
Data on school performance collected by the 8th grade teacher as part of routine school practice.
Measured: Past year
Secondary outcomes (6)
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.
Measured: Past 2 weeks
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.
Measured: Past 7 days
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.
Measured: Past 2 weeks
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.
Measured: Past week
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.
Measured: Past 6 weeks
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.
Measured: Past 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Jul 2016
- Primary completion30 May 2020
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Tamar Mendelson, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906682
- Sponsor's protocol ID
- R305A160082-17
- Other IDs
- R01HD090022
- Status last verified
- Aug 2022
- First submitted
- 14 Nov 2018
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAP Club: Improving Mental Health and School Performance in Urban Eighth Graders
- ClinicalTrials.gov ID
- NCT03906682
- Acronym / sponsor ID
- R305A160082-17
- Keywords
- prevention, urban youth, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Institute of Education Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAP Club program | Experimental | Behavioral: RAP ClubRAP 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. |
| Healthy Topics program | Active comparator | Behavioral: Healthy TopicsLike 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Non English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAP ClubRAP 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. | Behavioural | RAP Club program |
| Healthy TopicsCo-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. | Behavioural | Healthy Topics program |
Primary outcome
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.
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.
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.
Academic records
Time frame: Past year
Data on school performance collected by the 8th grade teacher as part of routine school practice.
6 secondary outcomes
Child PTSD Symptom Scale Revised (CPSSR)
Time frame: Past 2 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms
Time frame: Past 7 days
Children's Depression Inventory - Short Form (CDI-S)
Time frame: Past 2 weeks
Youth Outcome Questionnaire Self-Report (YOQSR)
Time frame: Past week
Brief Cope
Time frame: Past 6 weeks
Children's Response Style Questionnaire (CRSQ)
Time frame: Past 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamar Mendelson, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAP Club and Healthy Topics in people with Depressive Symptoms and Trauma, Psychological, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teacher Rating of Social Competence Scale (TRSCS) (time frame: Past three weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.