Clinical trial NCT02909673: School Based Program to Prevent Teen Dating Violence
Official title: Cluster Randomized Trial of School Based Program to Prevent Teen Dating Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Keywords: adolescent behavior
intimate partner violence
youth risk behavior
violence prevention
teen dating violence
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2016-09-21
Enrollment: 3028
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Reduction of student TDV
timeFrame: 3 years
Secondary outcomes:
measure: Emotional Well-being
timeFrame: 3 years
measure: Cognitive & Behavioral Correlates
timeFrame: 3 years
measure: School Climate
timeFrame: 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Independent School District
state: Texas
city: Sugar Land
country: United States
facility: Fort Bend Independent School District
state: Texas
Study officials:
affiliation: UTMB
name: Jeff R Temple, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Temple JR, Baumler E, Wood L, Thiel M, Peskin M, Torres E. A Dating Violence Prevention Program for Middle School Youth: A Cluster Randomized Trial. Pediatrics. 2021 Nov;148(5):e2021052880. doi: 10.1542/peds.2021-052880. Epub 2021 Oct 6.