NCT05639426

Brief Summary

Interpersonal or community violence is a long-standing health disparity that disproportionately affects African American youth, and suicide is disproportionately increasing among African American youth. This project evaluates the impact of a multisystemic prevention program designed to reduce health disparities in violence by promoting equity in African American youths' experiences in education systems. This intervention has the potential to reduce morbidity and mortality among African American youth, promote overall quality of life, and reduce the societal costs associated with both interpersonal violence and suicidality.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,672

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Sep 2022May 2027

Study Start

First participant enrolled

September 28, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

November 1, 2022

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (15)

  • Change in youth self-reported interpersonal violence perpetration

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess interpersonal violence perpetration, youth will complete the Problem Behavior Frequency Scales- Adolescent Revised, Physical Aggression subscale. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in teacher-reported youth interpersonal violence perpetration

    Teachers will complete surveys on a random sample of youth every three months over the school year for the entire project period. To assess youth interpersonal violence perpetration, teachers will complete the Problem Behavior Frequency Scales - Teacher Report, Physical Aggression subscale. Teacher report of youth will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in school discipline incidents for violent behavior

    We will collect archival data from the school system by participating school and quantify the number of violence-related discipline incidents (office discipline referrals, suspensions, and expulsions) that occur every three months. Violence-related discipline incidents will be aggregated to the community level to assess trajectories in community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported interpersonal violence victimization

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess interpersonal violence perpetration, youth will complete the Problem Behavior Frequency Scales- Adolescent Revised, Physical Victimization subscale. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported exposure to community violence

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess exposure to community violence, youth will complete the Survey of Children's Exposure to Violence scale. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in teacher-reported youth interpersonal violence victimization

    Teachers will complete surveys on a random sample of youth every three months over the school year for the entire project period. To assess youth interpersonal violence perpetration, teachers will complete the Problem Behavior Frequency Scales - Teacher Report, Victimization subscale. Teacher report of youth will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported suicide attempts

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess suicide attempts and plans, youth will complete three items from the Youth Risk Behavior Surveillance Survey, which will be summed to create a suicide attempts/plans index. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported suicide capacity

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess suicide capacity, youth will complete the Suicide Capacity Scale. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported suicide ideation

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess suicide ideation, youth will complete the suicide subscale of the Mood and Feelings Questionnaire. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in school-reported youth suicide-related incidents

    We will collect archival data from the each participating school and quantify the number of youth suicide-related incidents based on suicide protocols administered by the school counselor every three months. Youth suicide-related incidents will be aggregated to the community level to assess trajectories in community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth-reported race-based discrimination experiences

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess perceived racial discrimination, youth will complete the Adolescent Discrimination Distress Index. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth-reported perceptions of police

    A random sample of youth will complete surveys every three months over the school year for the entire project period. To assess their perceptions of police legitimacy, youth will complete the Perceptions of Police scale. Youth self-report will be aggregated to the community level to assess trajectories of community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in inclusive pedagogy

    Participating teachers in each school will provide example lesson plans on every three months. These lesson plans will be coded by trained graduate students in education using the Rubric for Culturally Responsive Lessons and Assignments, which will result in an inclusive pedagogy score. These scores will be aggregated to the community level to assess trajectories in community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in base rates in exclusionary discipline

    We will collect archival data from the school system by participating school and quantify the number of exclusionary discipline incidents (a combined measure of suspensions and expulsions) that occur every three months. Exclusionary discipline incidents will be aggregated to the community level to assess trajectories in community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in racial disparities in exclusionary discipline

    We will collect archival data from the school system by participating school and quantify the number of exclusionary discipline incidents (a combined measure of suspensions and expulsions) for Black youth and White youth that occur every three months. We will use that data to create an indicator of disproportionate exclusionary discipline based on the number of exclusionary discipline events per Black youth and per White youth separately in proportion to the number of White youth and Black youth in the school. Exclusionary discipline disproportionality will be aggregated to the community level to assess trajectories in community-level change over time as part of the multiple baseline design.

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

Secondary Outcomes (3)

  • Change in youth self-reported traumatic stress symptoms

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported depressive symptoms

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

  • Change in youth self-reported general internalizing symptoms

    Trajectories of change will be assessed through data collected every three months from August to May (the school year) over the course of five years (through study completion)

Study Arms (1)

Strengthening Opportunities for Achievement and Resilience

EXPERIMENTAL

Strengthening Opportunities for Achievement and Resilience (SOAR) is an intervention condition consisting of both Culturally-Responsive Schoolwide Positive Behavior Interventions and Supports (C-SWPBS) and Culturally Responsive Practices (CRP). It is a year-long, school-level intervention.

Behavioral: Culturally Responsive Practices (CRP)Behavioral: Culturally-Responsive Schoolwide Positive Behavior Interventions and Supports (C-SWPBS)

Interventions

We will implement SWPBS according to the equity-focused framework established by the Center on PBIS, with an increased emphasis on community integration. SWPBS involves creating a school team of 6-10 people, including at least one administrator, teachers, and staff members. We will include at least three community stakeholders on each C-SWPBS team to integrate the culture of the community, reducing institutional and cultural racism. Community stakeholders may be parents or other invested members of the local community not employed by the school district. The school climate specialists serve on the C-SWPBS team and provide consultation for the management of violence incidents and mental health concerns.

Strengthening Opportunities for Achievement and Resilience

The CRP component of the intervention targets pedagogy, curriculum, and potential teacher biases and discriminatory behavior. This component will consist of two intensive 4-hour workshops delivered by Morton and Billingsley in each school's first intervention year as well as one-hour annual boosters (Backpacks for Success and Culturally Relevant Pedagogy). All teachers and school administrators will participate in the workshops. The purpose of Backpacks for Success is to increase participants' awareness of structural racism, empathy for students, and motivation to change, while identifying equity targets and strategies to reach those targets. Culturally Relevant Pedagogy comprises classroom based strategies to promote equity, including use of culturally responsive curriculum, language, attitudes, and actions, with the goal of reducing interpersonal and cultural racism. Ongoing group coaching sessions will provide a space for peer support and learning around increasing CRP.

Strengthening Opportunities for Achievement and Resilience

Eligibility Criteria

Age10 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth will be eligible for the study if they attend a participating school, are capable of providing assent, and are able to understand spoken or written English.
  • School personnel will be eligible if they are currently employed at a participating school.

You may not qualify if:

  • Unable to give assent or consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Alabama

Mobile, Alabama, 36688, United States

Location

MeSH Terms

Conditions

Suicide

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2022

First Posted

December 6, 2022

Study Start

September 28, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Given the sensitivity of the youth data, we do not plan to make IPD available to other researchers except under specific circumstances. We will share the data on a case-by-case basis to qualified members of the research community through a Data Use Agreement and following documentation that they have obtained the approval of an institutional review board. We will ensure that all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use by creating a Data Codebook. This report will include (1) documentation of the measures and evidence of internal validity; and (2) participant recruitment, recruitment rates, and information about the survey administration process. Data will be self-archived on a secure university network drive through the university's library system. Vanderbilt University will be responsible for long-term preservation of the data.

Locations