School Based Program to Prevent Teen Dating Violence

Violence Clinical Trial

— CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909673
• Other study ID #: 15-0198
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: October 3, 2021

Study information

• Verified date: October 2021
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3028
• Est. completion date: October 3, 2021
• Est. primary completion date: October 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• n/a

Related Conditions & MeSH terms

• Violence

Intervention

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..

Locations

Country	Name	City	State
United States	Houston Independent School District	Houston	Texas
United States	Fort Bend Independent School District	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of student TDV	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	Emotional Well-being	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
Secondary	Cognitive & Behavioral Correlates	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
Secondary	School Climate	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