Aggressive Childhood BehaviorNCT04087772
Enhancing School-Based Violence Prevention
A study testing Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH) and Racial/Ethnic Discrimination Interventions (RED) in people with Aggressive Childhood Behavior, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Childhood Behavior
- What is being tested?
- Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH) and Racial/Ethnic Discrimination Interventions (RED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,840 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to 31 Dec 2025
- 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 10 to 105 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- for student participants: in 6th and 7th grades in a study school at study entry
- for teacher participants: teacher at a study school
Who cannot join
- .for student participants: intellectual disabilities, very limited reading abilities, or in foster care
Trial locations and contacts
1 site in 1 country.
United States1 site
Name and state withheld to protect anonyminty of study site
Charleston, South Carolina, 29407
About this study
Official title: 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.
- Conditions
- Aggressive Childhood Behavior
- Being tested
- Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH), Racial/Ethnic Discrimination Interventions (RED)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH)Behavioural
Also called Interconnected Systems Framework
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.
Racial/Ethnic Discrimination Interventions (RED)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health-Enhanced PBIS | Active comparator | 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. Receives: Behavioral: Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH) |
| Mental Health-Enhanced PBIS + RED | Experimental | 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. Receives: Behavioral: Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH); Behavioral: Racial/Ethnic Discrimination Interventions (RED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
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.
Measured: From first day of school in year 1 to last day of school in year 2
Secondary outcomes (2)
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)
Measured: 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
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)
Measured: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start13 Sep 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive Childhood BehaviorStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 4,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087772
- Sponsor's protocol ID
- 00085255
- Other IDs
- 1R01MD013812-01
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing School-Based Violence Prevention Through Multilevel Racial/Ethnic Discrimination Intervention
- ClinicalTrials.gov ID
- NCT04087772
- Acronym / sponsor ID
- 00085255
- Conditions
- Aggressive Childhood Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,840 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Sep 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Health-Enhanced PBIS | Active comparator | Behavioral: Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH)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 PBIS + RED | Experimental | Behavioral: Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH), Behavioral: Racial/Ethnic Discrimination Interventions (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. |
Who may qualify
- Ages
- 10 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- for student participants: in 6th and 7th grades in a study school at study entry
- for teacher participants: teacher at a study school
Key exclusion criteria (1 listed)
- .for student participants: intellectual disabilities, very limited reading abilities, or in foster care
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 |
|---|---|---|
| Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH)Also: Interconnected Systems FrameworkMental 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. | Behavioural | Mental Health-Enhanced PBIS, Mental Health-Enhanced PBIS + RED |
| Racial/Ethnic Discrimination Interventions (RED)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. | Behavioural | Mental Health-Enhanced PBIS + RED |
Primary outcome
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)
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)
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.
2 secondary outcomes
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)
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)
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 20 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Aggressive Childhood Behavior
RecruitingPhase 2
Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
Autism Spectrum Disorder, Challenging Behaviour
Recruiting
Examining the Efficacy of the PRAISE With Coaching Program
Aggression Childhood, Bullying Victimization
Active, not recruiting
Psychosocial Correlates of Trait Emotional Intelligence and Psychosomatic Symptoms Among Adolescents Exposed to Bullying and the Effects of Mindfulness-Based Stress Reduction.
Childhood Trauma, Stress
Enrolling by invitation
Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability
Autism, Intellectual Disability
Recruiting
Manualized Assessment and Treatment Model of Challenging Behavior
Problem Behavior, Aggression
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH) and Racial/Ethnic Discrimination Interventions (RED) in people with Aggressive Childhood Behavior, run by Medical University of South Carolina 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 2 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 20 Jan 2026. 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?
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 study lists 3 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 20 Jan 2026.