School Based Program to Prevent Teen Dating Violence (CRT)

October 11, 2021 updated by: The University of Texas Medical Branch, Galveston

Cluster Randomized Trial of School Based Program to Prevent Teen Dating Violence

This study is a school-based cluster randomized trial of the 7th grade version of Fourth R, a promising teen dating violence prevention program, with 24 ethnically diverse middle schools (12 intervention schools, 12 control schools) in one of the nation's largest school districts. Students (N = 3,375) will be the unit of analysis and studied prospectively (baseline, [post-intervention], and annually for 3 years) to determine the impact of the program by comparing students in intervention schools with those in control schools.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of teen dating violence (TDV), as well as the adverse mental, physical, and relationship health outcomes associated with it, underscores the need for effective TDV prevention programs, of which there are few.

The study will evaluate a new 7th-grade version of Fourth R, which has been rewritten to be developmentally appropriate and correspond to national health standards for this younger age. The 7th-grade version of Fourth R is innovative because it emphasizes socio-emotional learning, includes lessons on mental health, and addresses technology and cyber TDV. These additional components will strengthen the core social-emotional competencies of youth, competencies that are critical for the creation of healthy relationships and avoidance of unhealthy ones. A TDV prevention program aimed at promoting healthy relationships at this developmentally important age holds tremendous promise.

The primary aim is to determine whether Fourth R reduces students' TDV, as indexed by less perpetration and victimization of physical, sexual, and psychological TDV, relative to students in control schools.

The secondary aims are to determine whether Fourth R, relative to control, 1) improves students' [relationship quality], emotional well-being, and increases their acquisition and use of healthy relationship skills, as indexed by improved problem-solving, communication, and conflict resolution skills; 2) ameliorates the modifiable cognitive and behavioral correlates associated with the perpetration and victimization of TDV, as indexed by fewer attitudes justifying dating violence, decreased substance use, risky sexual behavior, fighting, and bullying, increased school connectedness, improved academic performance, and decreased psychological symptoms; and [3) improves school climate as indexed by student, teacher, and staff reports of school environment as it relates to healthy relationships and TDV; and by reductions in school disciplinary actions related to violence, substance use, and academic failure]. Prespecified differences by gender and ethnicity will be examined, as well as the acquisition and utilization of various program components.

Study Type

Interventional

Enrollment (Actual)

3028

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

  • United States
    • Texas
      • Houston, Texas, United States, 77092
        • Houston Independent School District
      • Sugar Land, Texas, United States, 77479
        • Fort Bend Independent School District

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

11 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attending 7th grade health class in Houston area middle schools

Exclusion Criteria:

  • n/a

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fourth R
Fourth R: 27 lesson curriculum addressing youth risk and health promoting behaviors
Behavioral: Fourth R
Fourth R integrates the promotion of healthy relationship skills and prevention of teen dating violence into existing school curricula so that students receive regular course credit in health. Fourth R is grounded in social cognitive theory in which youth learn to formulate and choose behavior strategies, which translate into knowledge and practice in decision-making, non-aggressive conflict resolution skills, and self-efficacy..
No Intervention: Control
Control: Treatment as usual (standard health class curriculum)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of student TDV
Time Frame: 3 years
determine whether Fourth R reduces students' TDV, as indexed by less perpetration and victimization of physical, sexual, and psychological TDV, relative to students in control schools
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Well-being
Time Frame: 3 years
Determine if Fourth R improves relationship quality, emotional well-being, and increases participant acquisition and use of healthy relationship skills, as indexed by improved problem-solving, communication, and conflict resolution skills
3 years
Cognitive & Behavioral Correlates
Time Frame: 3 years
Determine if Fourth R ameliorates the modifiable cognitive and behavioral correlates associated with the perpetration and victimization of TDV, as indexed by fewer attitudes justifying dating violence, decreased substance use, risky sexual behavior, fighting, and bullying, increased school connectedness, improved academic performance, and decreased psychological symptoms
3 years
School Climate
Time Frame: 3 years
Determine if Fourth R improves school climate as indexed by student, teacher, and staff reports of school environment as it relates to healthy relationships and TDV; and by reductions in school disciplinary actions related to violence, substance use, and academic failure
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Jeff R Temple, PhD, UTMB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 18, 2018

Primary Completion (Actual)

October 3, 2021

Study Completion (Actual)

October 3, 2021

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-0198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will comply with NIH

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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