Violence Prevention for Middle School Boys

• ClinicalTrials.gov Identifier: NCT03109184
• Recruitment Status: Completed
• First Posted: April 12, 2017
• Results First Posted: November 20, 2019
• Last Update Posted: November 20, 2019
• Sponsor: Northeastern University
• Collaborator: Rhode Island Hospital
• Information provided by (Responsible Party): Northeastern University

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 119 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
• Actual Primary Completion Date: August 30, 2018
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Dating Violence (DV) Perpetration From Baseline to 9 Months [ Time Frame: Baseline, 3 months, and 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.
2. Change in General Aggressive Behavior From Baseline to 9 Months [ Time Frame: Baseline, 3 months, 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.
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. Item responses ranged from 1-4 with 1=strongly agree, 2=agree, 3=disagree 4=strongly disagree. Higher scores indicate more favorable attitudes.

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. It produces two sub scales measuring short-term and long-term self-regulation. Item responses range from 1-5 with 1= Not at all true for me, 2= Rarely true for me, 3= True some of the time, 4= True most of the time, 5= Really true for me. Items were reverse coded so that higher scores indicate more use of emotion regulation behaviors.
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. This scale also produces two sub scales: The Open Family Communication Scale (OFCS) and The Problems in Family Communication Scale (PFCS). Item responses range from 1-5 with 1=Strongly disagree, 2=Moderately disagree, 3=Neither agree neither disagree, 4=Moderately agree, 5=Strongly agree. On the OFCS subscale, higher scores indicate more open communication. One the PFCS subscale, higher scores indicate fewer problems in family communication, thus higher scores on both subscales are favorable.
3. Change in Emotion Regulation Skills Baseline to 9 Months [ Time Frame: Baseline, 3 months, 9 months ]
   The Emotion Regulation Behavioral Skills (ERBS) scale is comprised of 8 items rated on a scale of 1 "all the time" to 5 "never" and was specifically created for to detect the use of the specific affect management strategies taught in the Project STRONG intervention. Sample items include "How often did you…get away from whatever was causing your feeling? …talk to someone about whatever was causing your feeling?" Higher scores indicate greater use of emotion regulation skills.
4. Change in Distress Tolerance From Baseline to 9 Months [ Time Frame: Baseline, 3 months, 9 months ]
   The Behavioral Indicator of Resiliency to Distress (BIRD) is a 5-minute computerized distress tolerance task for adolescents. This measure generates a score of total time that adolescents persist on a frustrating task, which has been linked to distress tolerance. Scores are recorded in milliseconds (ms) with a maximum time participants can persist is 300 seconds (0-300 is the range). Higher score indicate longer persistence during the frustrating task.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02905

Sponsors and Collaborators

Northeastern University

Rhode Island Hospital

Investigators

• Principal Investigator: Christie Rizzo, PhD; Northeastern University

  Study Documents (Full-Text)

Documents provided by Northeastern University:

Study Protocol and Statistical Analysis Plan  [PDF] August 1, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Northeastern University
• ClinicalTrials.gov Identifier: NCT03109184
• Other Study ID Numbers: 504616
• First Posted: April 12, 2017
• Results First Posted: November 20, 2019
• Last Update Posted: November 20, 2019
• Last Verified: March 2019

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