- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03109184
Violence Prevention for Middle School Boys
Partner Violence Prevention for Middle School Boys: A Dyadic Web-Based Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Rhode Island Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
Time Frame: Baseline, 3 months, and 9 months
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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.
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Baseline, 3 months, and 9 months
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Change in General Aggressive Behavior From Baseline to 9 Months
Time Frame: Baseline, 3 months, 9 months
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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.
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Baseline, 3 months, 9 months
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Change in Attitudes About Relationship Violence From Baseline to 9 Months
Time Frame: Baseline, 3 months, and 9 months
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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.
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Baseline, 3 months, and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Emotion Regulation Skills From Baseline to 9 Months
Time Frame: Baseline, 3 months, and 9 months
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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.
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Baseline, 3 months, and 9 months
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Change in Parent-Adolescent Communication From Baseline to 9 Months
Time Frame: Baseline, 3 months, and 9 months
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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.
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Baseline, 3 months, and 9 months
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Change in Emotion Regulation Skills Baseline to 9 Months
Time Frame: Baseline, 3 months, 9 months
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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.
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Baseline, 3 months, 9 months
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Change in Distress Tolerance From Baseline to 9 Months
Time Frame: Baseline, 3 months, 9 months
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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.
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Baseline, 3 months, 9 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 504616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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