Back to resultsEnhancing School-Based Violence Prevention
Primary Purpose
Aggressive Childhood Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH)
Racial/Ethnic Discrimination Interventions (RED)
Sponsored by
About this trial
This is an interventional prevention trial for Aggressive Childhood Behavior
Eligibility Criteria
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
Sites / Locations
- Name and state withheld to protect anonyminty of study siteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mental Health-Enhanced PBIS
Mental Health-Enhanced PBIS + RED
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mean change from baseline in student report on aggression as measured by the Reactive and Proactive Aggression Survey
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)
Mean change from baseline in teacher report on students' aggression as measured by the Teacher Report of Aggression
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)
Mean change from baseline in student aggression as measured by the number of Office Discipline Referrals per month
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.
Secondary Outcome Measures
Change from baseline in student report on discrimination from teachers as measured by the Adolescent Discrimination Index - Educational Discrimination Distress Subscale
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)
Change from baseline in student report on discrimination from peers as measured by the Adolescent Discrimination Index - Peer Discrimination Distress Subscale
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)
Full Information
NCT ID
NCT04087772
First Posted
September 11, 2019
Last Updated
February 10, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT04087772
Brief Title
Enhancing School-Based Violence Prevention
Official Title
Enhancing School-Based Violence Prevention Through Multilevel Racial/Ethnic Discrimination Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2019 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Childhood Behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4840 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mental Health-Enhanced PBIS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mental Health-Enhanced PBIS + RED
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH)
Other Intervention Name(s)
Interconnected Systems Framework
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Racial/Ethnic Discrimination Interventions (RED)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change from baseline in student report on aggression as measured by the Reactive and Proactive Aggression Survey
Description
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)
Time Frame
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Title
Mean change from baseline in teacher report on students' aggression as measured by the Teacher Report of Aggression
Description
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)
Time Frame
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Title
Mean change from baseline in student aggression as measured by the number of Office Discipline Referrals per month
Description
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.
Time Frame
From first day of school in year 1 to last day of school in year 2
Secondary Outcome Measure Information:
Title
Change from baseline in student report on discrimination from teachers as measured by the Adolescent Discrimination Index - Educational Discrimination Distress Subscale
Description
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)
Time Frame
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Title
Change from baseline in student report on discrimination from peers as measured by the Adolescent Discrimination Index - Peer Discrimination Distress Subscale
Description
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)
Time Frame
Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariana Lospinoso
Phone
843-985-2086
Email
lospinos@musc.edu
Facility Information:
Facility Name
Name and state withheld to protect anonyminty of study site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Withheld Withheld
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhancing School-Based Violence Prevention
We'll reach out to this number within 24 hrs