Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02080923
Other study ID # H-31501
Secondary ID 2013-VA-CX-0001
Status Completed
Phase N/A
First received March 4, 2014
Last updated June 19, 2017
Start date April 2014
Est. completion date June 13, 2017

Study information

Verified date June 2017
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date June 13, 2017
Est. primary completion date June 13, 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Motivational Interview
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.

Locations

Country Name City State
United States Boston University School of Public Health Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston University U.S. Department of Justice

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Program Cost-effectiveness Costs are the value of resources used before and during implementation to deliver the intervention. up to 18 months
Primary Dating Aggression Perpetration Change in the perpetration of dating aggression from baseline to follow-up. 3 months or 6 months
Primary Intentions to use physical violence during next partner conflict Change in the intention to use acts of physical violence during the next conflict with a dating partner 3 months or 6 months
Secondary Knowledge and Attitudes about Dating Aggression Change in Knowledge and Attitudes about Dating Aggression from baseline to the three month follow-up 3 months or 6 months
See also
  Status Clinical Trial Phase
Completed NCT03900650 - Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors N/A
Not yet recruiting NCT06158880 - Alcohol & Men's Sexual Risk Behaviors N/A
Completed NCT03159468 - Emotion Regulation Interventions for Alcohol-Related Sexual Aggression N/A
Completed NCT03521115 - Family Based Prevention of Alcohol and Risky Sex for Older Teens N/A

External Links