Clinical trial NCT03906682: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Trauma, Psychological
Disruptive Behavior
Keywords: prevention
urban youth
mindfulness
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-04-08
Enrollment: 615
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Teacher Rating of Social Competence Scale (TRSCS)
timeFrame: Past three weeks
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Past 6 weeks
measure: Academic Competence Evaluation Scale (ACES)
timeFrame: Past 6 weeks
measure: Academic records
timeFrame: Past year
Secondary outcomes:
measure: Child PTSD Symptom Scale Revised (CPSSR)
timeFrame: Past 2 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms
timeFrame: Past 7 days
measure: Children's Depression Inventory - Short Form (CDI-S)
timeFrame: Past 2 weeks
measure: Youth Outcome Questionnaire Self-Report (YOQSR)
timeFrame: Past week
measure: Brief Cope
timeFrame: Past 6 weeks
measure: Children's Response Style Questionnaire (CRSQ)
timeFrame: Past 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Tamar Mendelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: