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Violence Prevention for Middle School Boys

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ClinicalTrials.gov Identifier: NCT03109184
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by (Responsible Party):
Northeastern University

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.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence Behavioral: Project STRONG Not Applicable

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 develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to prevent DV.

Development and testing will occur in three phases. In the Development Phase, the intervention modules will be developed and iteratively reviewed by both a panel of experts familiar with the research in the field as well as an advisory group of parents and teens from the target population. In the Acceptability Testing Phase, testing will be conducted to assess acceptability and feasibility, and this will be followed by revisions to the intervention program based on feedback and observations. During the Randomized Controlled Trial (RCT) Phase, 120 families will complete the intervention 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-,and 9-month follow-ups.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Partner Violence Prevention for Middle School Boys: A Dyadic Web-Based Intervention
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
No Intervention: Waitlist Control
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.
Experimental: Project STRONG
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
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.




Primary Outcome Measures :
  1. Change in Dating Violence Perpetration and Victimization from Baseline to 9 months [ Time Frame: Baseline, 3 months, and 9 months ]
    Conflict in Adolescent Dating Relationships Inventory (CADRI)


Secondary Outcome Measures :
  1. Change in Emotion Regulation Skills from Baseline to 9 months [ Time Frame: Baseline, 3 months, and 9 months ]
    The Adolescent Self-Regulatory Inventory (ASRI) is a 33 item survey that measures adolescents' use of both functional and dysfunctional emotion regulation strategies

  2. Change in Parent-Adolescent Communication from Baseline to 9 months [ Time Frame: Baseline, 3 months, and 9 months ]
    Parent Adolescent Communication Survey (PACS) is 20 item survey measuring quality of communication between adolescents and their parents. Adolescents will complete the measure in reference to the parent participating in the intervention with them. This is completed by parents and youth.

  3. Change in Attitudes about Relationship Violence from Baseline to 9 months [ Time Frame: Baseline, 3 months, and 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.

  4. Change in Sexual Risk behavior from Baseline to 9 months [ Time Frame: Baseline, 3 months, and 9 months ]
    The Adolescent Risk Behavior Assessment (ARBA) assesses type of sexual behavior, frequency of sex and condom use, number of partners, as well as intentions to have sex, use condoms and get someone pregnant.



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Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility based on youth self-representation as male gender
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) adolescent enrolled in the 7th or 8th grade,
  • 2) parent/legal guardian and teen are English speaking,
  • 3) parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
  • 4) adolescent is willing to provide assent for their own participation.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109184


Contacts
Contact: Christie Rizzo, PhD 6173732486 c.rizzo@northeastern.edu
Contact: Chris Houck, PhD CHouck@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Chris Houck, PhD       CHouck@lifespan.org   
Sponsors and Collaborators
Northeastern University
Rhode Island Hospital
Investigators
Principal Investigator: Christie Rizzo, PhD Northeastern University

Responsible Party: Northeastern University
ClinicalTrials.gov Identifier: NCT03109184     History of Changes
Other Study ID Numbers: 504616
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Northeastern University:
Dating violence prevention
Adolescent boys
Middle school
Web-based prevention