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Behavioral Intervention

Violence Prevention Programs for Aggression

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

for student participants: in 6th and 7th grades in a study school at study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first day of school in year 1 to last day of school in year 2

Awards & highlights

Study Summary

This trial will compare two ways of reducing aggression in middle school students.

Who is the study for?

This trial is for middle school teachers and their students in 6th and 7th grades at participating schools. Students with intellectual disabilities, very limited reading abilities, or those in foster care are not eligible to participate.Check my eligibility

What is being tested?

The study is testing two programs aimed at reducing aggression among middle schoolers: Racial/Ethnic Discrimination Interventions (RED) and a mental health-focused version of Positive Behavioral Interventions and Supports (PBIS-MH).See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience emotional or psychological responses to the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a student in the 6th or 7th grade at a school participating in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first day of school in year 1 to last day of school in year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first day of school in year 1 to last day of school in year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first day of school in year 1 to last day of school in year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change from baseline in student aggression as measured by the number of Office Discipline Referrals per month

Mean change from baseline in student report on aggression as measured by the Reactive and Proactive Aggression Survey

Mean change from baseline in teacher report on students' aggression as measured by the Teacher Report of Aggression

Secondary outcome measures

Change from baseline in student report on discrimination from peers as measured by the Adolescent Discrimination Index - Peer Discrimination Distress Subscale

Change from baseline in student report on discrimination from teachers as measured by the Adolescent Discrimination Index - Educational Discrimination Distress Subscale

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mental Health-Enhanced PBIS + REDExperimental Treatment2 Interventions

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.

Group II: Mental Health-Enhanced PBISActive Control1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,211,519 Total Patients Enrolled

1 Trials studying Oppositional Defiant Disorder

34 Patients Enrolled for Oppositional Defiant Disorder

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,389,795 Total Patients Enrolled

Media Library

PBIS-MH (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04087772 — N/A

Oppositional Defiant Disorder Research Study Groups: Mental Health-Enhanced PBIS, Mental Health-Enhanced PBIS + RED

Oppositional Defiant Disorder Clinical Trial 2023: PBIS-MH Highlights & Side Effects. Trial Name: NCT04087772 — N/A

PBIS-MH (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04087772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this experiment encompass participants above twenty-five years old?

"The age range for participant eligibility is from 10 to 105 years old. This study requires the enrollment of 17 minors and 50 elderly individuals."

Answered by AI

Is this research endeavor presently seeking volunteers?

"Correct. Clinicaltrials.gov demonstrates that this medical trial, which was initially listed on September 13th 2019, is still recruiting participants for its research goals. A total of 4840 patients must be sourced from 1 regional site."

Answered by AI

How many participants are being observed in this experiment?

"Affirmative. Clinicaltrials.gov verifies that this experiment, which originally appeared on September 13th 2019, is presently recruiting participants. Approximately 4840 individuals must be enlisted from a single site."

Answered by AI

What prerequisites must potential participants fulfill to qualify for this experiment?

"This research project is seeking out 4840 applicants that possess aggressive childhood tendencies and range in age between 10 to 105. Those hoping to be enrolled must meet these criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing School-Based Violence Prevention

Colleen Halliday, PhD 2019. "Enhancing School-Based Violence Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04087772.