Clinical trial NCT04312867: Dating Violence Prevention Program Focusing on Middle School Boys
Official title: Dating Violence Prevention Program Focusing on Middle School Boys
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent Dating Violence
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 340
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.

Detailed description: Over the past ten years dating violence (DV) has been recognized as a significant public health problem affecting adolescents. Emerging data suggest that boys and girls have different developmental trajectories toward violence and therefore prevention programs that target their unique pathways to DV are needed. Despite this need, there is a relative dearth of such gender-informed programs for early adolescent boys. This research project aims to prevent the emergence of DV perpetration/ victimization among boys by developing a web-based intervention that is informed by research on gender-specific pathways to violence and harnesses the influence of parents during the early adolescent years.

Among boys, the perpetration of delinquency-related violence and attitudes supporting violence has been found to predict later perpetration of DV. Thus, gender-informed interventions designed to prevent DV in boys need to target skills that underlie violent behavior and attitudes. The goal of this study is to test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to prevent DV.

A pilot trial was conducted to create and test the efficacy of the web-based intervention. Preliminary results suggested the program was effective in reducing dating-violence involvement. This Randomized Controlled Trial (RCT) will test the efficacy of the intervention against an active control designed to provide health related information in a format similar to that of the intervention condition. 340 families (English or Spanish-speaking) will be randomly assigned to complete the intervention program or the health-promotion control program. All families will complete the program in an observed setting, to ensure fidelity to intervention dosing. Parents and adolescents will complete the program together and then complete assessments of aggressive and risk behaviors, parent-child communication, and emotion regulation at baseline, 3-month,6-month, 12-month, 18-month, and 24-month follow-ups.

Eligibility criteria: Inclusion Criteria:

1. adolescent is between 12 and 15 years old
2. adolescent identifies as male
3. adolescent enrolled in the 7th or 8th grade at a participating school,
4. parent/legal guardian and teen are English or Spanish speaking,
5. parent/legal guardian and son reside together at least 50% of the time,
6. parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
7. adolescent is willing to provide assent for their own participation.

Exclusion Criteria:

1. adolescent or parent is unable to read at a 4th grade level or has developmental delays,
2. other family members in household have previously participated in the study

Primary outcomes:
measure: Change in dating violence perpetration and victimization from baseline to 24-months
timeFrame: At baseline, participants will report lifetime and past 6-month DV. For all other time points we will assess the past 6 months
Secondary outcomes:
measure: Change in number of relationship from baseline to 24 months
timeFrame: Baseline, 3, 6, 12, 18, 24 months
measure: Change in attitudes about relationship violence from baseline to 24 months
timeFrame: Baseline, 3, 6, 12, 18, 24 month followup
measure: Change in aggressive behavior from baseline to 24 months
timeFrame: Baseline, 3, 6, 12, 18, 24 month followup
measure: Change in digital abuse behaviors from baseline to 24 months
timeFrame: Baseline, 6, 12, 18, 24 month followup
Other outcomes:
measure: Change in frequency of sexual and substance use behaviors from baseline to 24 months
timeFrame: Baseline, 6, 12, 18, 24 month followup
measure: Change in bullying behaviors from baseline to 24 months
timeFrame: Baseline, 6, 12, 18, 24 month followup
measure: School discipline actions from baseline to 24 months
timeFrame: 24 month followup
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: