- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080923
A Brief Intervention to Prevent Adolescent Dating Aggression Perpetration (PLR)
The proposed study is a test of the feasibility and preliminary efficacy of a brief motivational interview style intervention. The intervention will take place in the pediatric emergency department of the Boston University Medical Center by a trained interventionist and will follow an intervention manual developed by a team of dating abuse and brief intervention experts. The study will involve two randomized groups of youth age 15-19: one group will receive the intervention and the other will not. The study will compare changes in data from baseline to 3- and 6-month follow-up for those in both groups. Outcomes including dating abused related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization) will be assessed.
The hypothesis of this study is that youth who receive the intervention will show improvements in dating abuse related knowledge, attitudes and behavior that are maintained for 6 months, while those in the control group will show no similar change.
Study Overview
Status
Intervention / Treatment
Detailed Description
Emergency departments offer a unique setting through which we can reach adolescents who have perpetrated Adolescent Dating Aggression (ADA). The Project READY (Reducing Aggression in Dating Relationships for Youth) brief intervention manual and training was developed by Dr. Emily Rothman, who is a former shelter worker, batterer intervention counselor, and dating violence expert, with input from research experts in brief intervention, an expert in adolescent batterer intervention, psychologists, low-income youth of color from the Start Strong Initiative, and others, with funding from the National Institutes of Health (NIH). The READY intervention intercepts youth who utilize an urban emergency department for non-acute health care needs (e.g., cuts, sprains), provides them with tailored feedback about their relationship behavior, and uses motivational interviewing techniques and prepared worksheets to move them forward on a readiness-to-change continuum towards non-violent and respectful relationship behavior. For example, after being provided with information about acts considered unhealthy in a relationship, a participant is asked to generate a list of "pros and cons" about what he or she does to solve conflicts with partners, brainstorm alternatives that he or she would use, list reasons why the alternatives might not work in the moment, and troubleshoot those potential problems. Participants are then offered a menu of referrals and invited to select those that they would use (e.g., free mental health and substance abuse counseling, sexual health testing, gang prevention resources).
The randomized controlled trial (RCT) research study will build upon our completed small-scale feasibility pilot project, which was conducted in 2012- 13. For the proposed study, we will recruit a sample large enough to evaluate whether the intervention improves ADA-related knowledge, positively changes ADA-related attitudes and behavioral intentions, and reduces self-reported perpetration behavior after 3- and 6-month follow-up periods. The study will enroll youth ages 15-19 years old. Notably, the setting for this intervention test will be an urban pediatric emergency department that primarily serves low income youth.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston University School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- must be a patient of the Pediatric Emergency Department or adolescent outpatient center at the Boston University Medical Center
- must be 15-19 years old
- have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months
- English-speaking
Exclusion Criteria:
- patient's reason for visit to the healthcare center is an acute mental health problem
- patient is a prisoner or juvenile detainee
- patient is determined to be a potentially lethal dating abuse offender based on a lethality checklist
- patient has cognitive or psychiatric limitations that render him/her unable to complete the eligibility form independently
- currently attending a batterer intervention program
- receiving care for violent trauma victimization
- appears intoxicated or high on drugs at the time of eligibility screening, or has informed medical staff that they are
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Motivational Interview
Health-related counseling that takes place in as little as one hour or up to a few sessions.
|
The intervention is exclusively focused on Adolescent Dating Aggression and will always be delivered by a human interventionist.
It is theory-based and its success as an intervention method for substance abuse and several other health-related issues is well established.
|
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No Intervention: Standard Care
Participant will receive information about dating abuse in a handout and referrals to a national domestic violence hotline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dating Aggression Perpetration
Time Frame: 3 months or 6 months
|
Change in the perpetration of dating aggression from baseline to follow-up.
|
3 months or 6 months
|
|
Intentions to use physical violence during next partner conflict
Time Frame: 3 months or 6 months
|
Change in the intention to use acts of physical violence during the next conflict with a dating partner
|
3 months or 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge and Attitudes about Dating Aggression
Time Frame: 3 months or 6 months
|
Change in Knowledge and Attitudes about Dating Aggression from baseline to the three month follow-up
|
3 months or 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program Cost-effectiveness
Time Frame: up to 18 months
|
Costs are the value of resources used before and during implementation to deliver the intervention.
|
up to 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily F Rothman, MS, ScD, Boston University
Publications and helpful links
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Adolescent
- Female
- Male
- Randomized Control Trial
- Adolescent Behavior
- Risk-Taking
- Age Factors
- Dating Violence
- Courtship
- Minority Groups/statistics & numerical data
- Sex Factors
- Sexual Behavior/statistics & numerical data
- Substance-Related Disorders/epidemiology
- Urban Population/statistics & numerical data
- Violence/statistics & numerical data
- Dating Aggression
- Perpetration
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-31501
- 2013-VA-CX-0001 (Other Grant/Funding Number: Sponsor Name: National Institute of Justice)
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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