NCT04312867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

July 30, 2025

Status Verified

October 1, 2024

Enrollment Period

5.7 years

First QC Date

March 16, 2020

Last Update Submit

July 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in dating violence perpetration and victimization from baseline to 24-months

    The Conflict in Adolescent Dating Relationships Inventory (CADRI), completed by dating teens, assesses verbal, emotional, physical, and sexual dating abuse perpetration and victimization with a current or recent dating partner. The CADRI has strong internal consistency (total α=.83) and 2-week test retest reliability, r=.68, p\<.01, as well as acceptable partner agreement (r=.64, p\<.01).

    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 (4)

  • Change in number of relationship from baseline to 24 months

    Baseline, 3, 6, 12, 18, 24 months

  • Change in attitudes about relationship violence from baseline to 24 months

    Baseline, 3, 6, 12, 18, 24 month followup

  • Change in aggressive behavior from baseline to 24 months

    Baseline, 3, 6, 12, 18, 24 month followup

  • Change in digital abuse behaviors from baseline to 24 months

    Baseline, 6, 12, 18, 24 month followup

Other Outcomes (3)

  • Change in frequency of sexual and substance use behaviors from baseline to 24 months

    Baseline, 6, 12, 18, 24 month followup

  • Change in bullying behaviors from baseline to 24 months

    Baseline, 6, 12, 18, 24 month followup

  • School discipline actions from baseline to 24 months

    24 month followup

Study Arms (2)

Project STRONG

EXPERIMENTAL

Project STRONG is an active skill-based intervention designed to prevent adolescent dating violence among middle school boys. Boys and a parent will complete the web-based program together focusing on improving communication and emotion regulation.

Behavioral: Project STRONG

Health Promotion

ACTIVE COMPARATOR

Health Promotion is an information-based program designed to mimic content areas provided during middle-school health education. The content is provided via a web-based interface to mirror the content delivery in the active intervention (Project STRONG).

Behavioral: Health Promotion

Interventions

Project STRONGBEHAVIORAL

Project STRONG is a 6-module web-based, dyadic intervention for middle school boys and their parents to complete. Its goal is primary prevention of adolescent dating violence by targeting parent-child communication and emotion regulation ability.

Project STRONG

Health promotion is a 6 module web-based, health information program designed to provide health content similar to that provided in a middle school health class. This program is designed to mirror Project STRONG for time and delivery method.

Health Promotion

Eligibility Criteria

Age12 Years - 15 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 09203, United States

Location

MeSH Terms

Interventions

Health Promotion

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

October 1, 2019

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

July 30, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Per NIH data sharing policy (2015), within one year of completion of the study and dissemination of primary study results, deidentified datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be deposited within one year of dissemination of primary study results to the National Institute of Child Health and Human Development Data and Specimen Hub (DASH). Access will be managed by DASH.
Access Criteria
Access to the deidentified data will be managed by DASH.

Locations