Real Talk Brief Intervention Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Boston University
Sponsor:
Collaborator:
U.S. Department of Justice
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01632176
First received: June 28, 2012
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

This randomized controlled trial (RCT) study is a small scale test of the feasibility and preliminary efficacy of a brief motivational interview-style intervention. The intervention will take place in the pediatric and adult emergency departments by a trained interventionist and will follow an intervention algorithm developed by a team of dating abuse and brief intervention experts. The research design is as follows: the investigators will randomize youth ages 15-19 to one of two groups: one group who receives the intervention (N=~180), and the other which does not (N=~180). The investigators will compare changes in outcomes from baseline to 6-month follow-up for those in both groups. The investigators will be looking at outcomes including dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization).

Statement of study hypothesis: 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 comparison group will show no similar change.


Condition Intervention Phase
Dating Violence
Dating Abuse
Behavioral: Real Talk Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Real Talk Brief Intervention Study

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Dating abuse perpetration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self-reported perpetration of dating abuse, including acts such as pushing, hitting, kicking and forcing partner to have sex.


Estimated Enrollment: 360
Study Start Date: March 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patients in the control group will not receive any intervention, but will receive standard care for dating abuse issues.
Experimental: Intervention
Patients in the intervention group will participate in the intervention.
Behavioral: Real Talk Intervention
This is a one session brief motivational interview-style intervention that follows a 9-step intervention algorithm. The intervention is delivered by a trained motivational interview interventionist. There are 3 booster calls up to six weeks following the intervention.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 15-19 years old
  • English-speaking
  • Have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months

Exclusion Criteria:

  • Patient's reason for ED visit is an acute mental health problem (e.g., suicidal ideation or attempt, severe anxiety attack)
  • Patient is a prisoner
  • Patient is determined to be potentially lethal
  • Patient attends batterer intervention classes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632176

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Emily F Rothman, ScD    617-414-1385    erothman@bu.edu   
Contact: Jennifer K Paruk    617-414-1381    jenparuk@bu.edu   
Principal Investigator: Emily F Rothman, ScD         
Sponsors and Collaborators
Boston University
U.S. Department of Justice
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01632176     History of Changes
Other Study ID Numbers: 5K01AA017630-04
Study First Received: June 28, 2012
Last Updated: July 23, 2015
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Boston University:
dating abuse
dating violence
domestic violence
sexual violence
sexual assault
youth violence
underage alcohol use
alcohol use

ClinicalTrials.gov processed this record on September 03, 2015