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Adolescent Dating ViolenceNCT04312867

Dating Violence Prevention Program Focusing on Middle School Boys

A study testing Project STRONG and Health Promotion in people with Adolescent Dating Violence, run by Rhode Island Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 15 years, men onlyHealthy volunteers can take part
Conditions the study is for
Adolescent Dating Violence
What is being tested?
Project STRONG and Health Promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • Men only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rhode Island Hospital

    Providence, Rhode Island, 09203

Other trials in United States

About this study

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.

Read the 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.

Being tested
Project STRONG, Health Promotion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project STRONGBehavioural

    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.

  • Health PromotionBehavioural

    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.

Study groups in NCT04312867
Study groupRoleWhat they receive
Project STRONGExperimentalProject 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.
Receives: Behavioral: Project STRONG
Health PromotionActive comparatorHealth 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).
Receives: Behavioral: Health Promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  1. Change in number of relationship from baseline to 24 months

    The Relationship Inventory will obtain general information about adolescents' romantic relationships via 11 items assessing number of relationships, duration, time since last relationship, and number of relationships terminated or not initiated due to concerns about DV.

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

  2. Change in attitudes about relationship violence from baseline to 24 months

    Attitudes about Relationship Violence Questionnaire (ARVQ; 39 items), completed by parents and teens, assesses knowledge, attitudes, and methods of dealing with DV (subscale αs = .75 -.87).

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

  3. Change in aggressive behavior from baseline to 24 months

    The Aggression Questionnaire (AQ)110 has 34 items that rate five types of aggression (e.g., physical, verbal) (α=.94, rtt =.80, total score).

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

  4. Change in digital abuse behaviors from baseline to 24 months

    The Electronic Behaviors in Adolescent Relationships (EBAR) assesses digital forms of DV perpetration and victimization through 32 items

    Measured: Baseline, 6, 12, 18, 24 month followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start1 Oct 2019
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04312867
Sponsor's protocol ID
R01HD097126
Status last verified
Oct 2024
First submitted
16 Mar 2020
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Project STRONG and Health Promotion in people with Adolescent Dating Violence, run by Rhode Island Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dating violence perpetration and victimization from baseline to 24-months (time frame: At baseline, participants will report lifetime and past 6-month DV. For all other time points we will assess the past 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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