- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087772
Enhancing School-Based Violence Prevention
January 16, 2026 updated by: Medical University of South Carolina
Enhancing School-Based Violence Prevention Through Multilevel Racial/Ethnic Discrimination Intervention
The purpose of this study is to compare two versions of Mental Health Enhanced Positive Behavioral Interventions and Supports in reducing aggression in middle school students.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
4840
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29407
- Name and state withheld to protect anonyminty of study site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 105 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- for student participants: in 6th and 7th grades in a study school at study entry
- for teacher participants: teacher at a study school
Exclusion Criteria:
- .for student participants: intellectual disabilities, very limited reading abilities, or in foster care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mental Health-Enhanced PBIS
Mental health-enhanced Positive Behavioral Interventions and Supports (PBIS-MH) integrates mental health into the three core elements of PBIS. 1) School-based mental health clinicians are included on leadership teams.
2) Data from teacher and student perceived school climate, as well as universal screening for aggression and mental health difficulties, are used to inform intervention decision-making.
3) Evidence-based mental health prevention and intervention practices are layered into PBIS' three-tiered continuum.
|
Mental health-enhanced Positive Behavioral Interventions and Supports (PBIS-MH) integrates mental health into the three core elements of PBIS. 1) School-based mental health clinicians are included on leadership teams.
2) Data from teacher and student perceived school climate, as well as universal screening for aggression and mental health difficulties, are used to inform intervention decision-making.
3) Evidence-based mental health prevention and intervention practices are layered into PBIS' three-tiered continuum.
Other Names:
|
|
Experimental: Mental Health-Enhanced PBIS + RED
PBIS-MH+RED involves the components of PBIS-MH integrated with racial/ethnic discrimination interventions (RED) to address multiple forms of school-based racial and ethnic discrimination.
1) Unintentional bias training for school personnel, involving teaching participants to conceptualize prejudice as well as strategies to reduce bias.
2) Unintentional bias training for students that is delivered in a classroom in a developmentally appropriate lesson format.
3) Vulnerable Decision Point process: Leadership teams are trained to reduce disparities in school discipline by a) using disaggregated student discipline data to identify particular settings or practices that are drivers for racial/ethnic disproportionality in a school and b) using iterative problem-solving to address these drivers.
4) Teacher stress reduction training where they are provided with strategies to reduce stress.
|
Mental health-enhanced Positive Behavioral Interventions and Supports (PBIS-MH) integrates mental health into the three core elements of PBIS. 1) School-based mental health clinicians are included on leadership teams.
2) Data from teacher and student perceived school climate, as well as universal screening for aggression and mental health difficulties, are used to inform intervention decision-making.
3) Evidence-based mental health prevention and intervention practices are layered into PBIS' three-tiered continuum.
Other Names:
Racial/Ethnic Discrimination Interventions are a set of components to address multiple forms of school-based racial and ethnic discrimination.
1) Unintentional bias training for school personnel, involving teaching participants to conceptualize prejudice as well as strategies to reduce bias.
2) Unintentional bias training for students that is delivered in a classroom in a developmentally appropriate lesson format.
3) Vulnerable Decision Point process: Leadership teams are trained to reduce disparities in school discipline by a) using disaggregated student discipline data to identify particular settings or practices that are drivers for racial/ethnic disproportionality in a school and b) using iterative problem-solving to address these drivers.
4) Teacher stress reduction training where they are provided with strategies to reduce stress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change from baseline in student report on aggression as measured by the Reactive and Proactive Aggression Survey
Time Frame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
The Reactive and Proactive Aggression Survey is a self-report instrument assessing how often the respondent has behaved aggressively towards other children over the past three months.
Scores range from 0 (Never) to 5 (All of the time)
|
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
|
Mean change from baseline in teacher report on students' aggression as measured by the Teacher Report of Aggression
Time Frame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
The Teacher Report of Aggression is a teacher-report survey completed by teachers assessing a student's tendency to be aggressive.
Scores range from 1 (Never) to 5 (All of the time)
|
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
|
Mean change from baseline in student aggression as measured by the number of Office Discipline Referrals per month
Time Frame: From first day of school in year 1 to last day of school in year 2
|
Office Discipline Referrals are official school records recorded for each behavioral infraction warranting referral to the school office.
Office Discipline Referrals for aggressive behavior (i.e.
bullying, fighting, making threats) will be counted.
The minimum score is 0 an there is no maximum score.
|
From first day of school in year 1 to last day of school in year 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in student report on discrimination from teachers as measured by the Adolescent Discrimination Index - Educational Discrimination Distress Subscale
Time Frame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
The Adolescent Discrimination Index is a self-report survey assessing the respondent's own experiences of racial/ethnic discrimination.
The Education subscale assesses discrimination from school teachers.The respondent indicates whether they have experienced discrimination, either Yes or No.
If the respondent selects Yes, they rate how upsetting the experience was with scores ranging from 1 (Not at all) to 5 (Extremely)
|
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
|
Change from baseline in student report on discrimination from peers as measured by the Adolescent Discrimination Index - Peer Discrimination Distress Subscale
Time Frame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
The Adolescent Discrimination Index is a self-report survey assessing the respondent's own experiences of racial/ethnic discrimination.
The Peer subscale assesses discrimination from peers.
The respondent indicates whether they have experienced discrimination, either Yes or No.
If the respondent selects Yes, they rate how upsetting the experience was with scores ranging from 1 (Not at all) to 5 (Extremely)
|
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2019
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
September 11, 2019
First Submitted That Met QC Criteria
September 11, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00085255
- 1R01MD013812-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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