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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04087772
Other study ID # 00085255
Secondary ID 1R01MD013812-01
Status Recruiting
Phase N/A
First received
Last updated
Start date September 13, 2019
Est. completion date July 30, 2024

Study information

Verified date February 2024
Source Medical University of South Carolina
Contact Daniela Robles
Phone 8438761800
Email roblesd@musc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4840
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 105 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Name and state withheld to protect anonyminty of study site Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Primary 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) Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Primary 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. From first day of school in year 1 to last day of school in year 2
Secondary 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) Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Secondary 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) Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03683056 - Mental Health Prevention Among Preschool Children Effectiveness Study N/A
Active, not recruiting NCT03383172 - Mental Health Prevention Among Preschool Children Using a Culturally Adapted Version of ICPS N/A