NCT03109184

Brief Summary

This study will develop and 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
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 20, 2019

Completed
Last Updated

November 20, 2019

Status Verified

March 1, 2019

Enrollment Period

3.7 years

First QC Date

April 6, 2017

Results QC Date

March 29, 2019

Last Update Submit

October 29, 2019

Conditions

Keywords

Dating violence preventionAdolescent boysMiddle schoolWeb-based prevention

Outcome Measures

Primary Outcomes (3)

  • Change in Dating Violence (DV) Perpetration From Baseline to 9 Months

    The Conflict in Adolescent Dating Relationships Inventory (CADRI) is a behavioral measure of abuse perpetration and victimization. It was completed by teens in reference to conflict or disagreement with a current or recent dating partner. Each question is asked twice, first regarding perpetration and, again in relation to victimization producing a perpetration and a victimization sub scale. Percentages include teens endorsing any perpetration or victimization.

    Baseline, 3 months, and 9 months

  • Change in General Aggressive Behavior From Baseline to 9 Months

    The Aggression Questionnaire (AQ) is a 34-item questionnaire that rates five types of aggression (physical aggression, verbal aggression, anger, hostility, and indirect aggression). Item responses ranged from 1-5, with 1=Not at all like me, 2=A little like me, 3=Somewhat like me, 4=Very much like me, 5=Completely like me. Higher scores indicate more aggression.

    Baseline, 3 months, 9 months

  • Change in Attitudes About Relationship Violence From Baseline to 9 Months

    Adolescent Relationship Violence Questionnaire (ARVQ) is a 22-item questionnaire is a composite measure developed to assess changes in knowledge, attitudes, and methods of dealing with relationship violence. Item responses ranged from 1-4 with 1=strongly agree, 2=agree, 3=disagree 4=strongly disagree. Higher scores indicate more favorable attitudes.

    Baseline, 3 months, and 9 months

Secondary Outcomes (4)

  • Change in Emotion Regulation Skills From Baseline to 9 Months

    Baseline, 3 months, and 9 months

  • Change in Parent-Adolescent Communication From Baseline to 9 Months

    Baseline, 3 months, and 9 months

  • Change in Emotion Regulation Skills Baseline to 9 Months

    Baseline, 3 months, 9 months

  • Change in Distress Tolerance From Baseline to 9 Months

    Baseline, 3 months, 9 months

Study Arms (2)

Waitlist Control

NO INTERVENTION

Parents and teens enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.

Project STRONG

EXPERIMENTAL

The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.

Behavioral: Project STRONG

Interventions

Project STRONGBEHAVIORAL

The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.

Project STRONG

Eligibility Criteria

Age12 Years - 14 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsEligibility based on youth self-representation as male gender
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \) adolescent enrolled in the 7th or 8th grade,
  • \) parent/legal guardian and teen are English speaking,
  • \) 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:

  • \) observable cognitive or developmental delays that would preclude participation,
  • \) residing with participating parent/guardian less than half time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

  • Rizzo CJ, Houck C, Barker D, Collibee C, Hood E, Bala K. Project STRONG: an Online, Parent-Son Intervention for the Prevention of Dating Violence among Early Adolescent Boys. Prev Sci. 2021 Feb;22(2):193-204. doi: 10.1007/s11121-020-01168-6. Epub 2020 Sep 17.

Limitations and Caveats

The primary limitation of this pilot Randomized Controlled Trial was the small sample size. A larger trial with more diverse group of families is needed.

Results Point of Contact

Title
DR. CHRISTIE RIZZO
Organization
NORTHEASTERN UNIVERSITY

Study Officials

  • Christie Rizzo, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

April 6, 2017

First Posted

April 12, 2017

Study Start

January 1, 2015

Primary Completion

August 30, 2018

Study Completion

December 31, 2018

Last Updated

November 20, 2019

Results First Posted

November 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations