Motivational Interviewing Intervention for Intimate Partner Violence (ISIS)

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01410669
First received: August 1, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

This project is a randomized trial to determine if motivational interviewing (MI) is an effective intervention to help women in abusive intimate relationships. The study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. This project will be integrated into the setting of a busy family planning clinic in the mid-western United States, which serves a largely rural population. Intimate partner violence (IPV) is screened using the Women's Experience with Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized to the intervention or to usual care group, and complete the 6-month study protocol. All subjects complete a self-administered computer-based questionnaire at the initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of readiness to change, selected IPV-related health correlates (e.g., depression), and steps taken and resources used. The MI intervention is an "active listening" counseling technique aimed at guiding the patient towards identifying feasible, personalized goals and steps she can take to increase her self-efficacy and control in the relationship. The trained study interviewer will work with participants to identify steps they can safely take and local resources to help them meet their goals. The MI protocol consists of a face-to-face counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to reinforce the intervention and assess the participants' level safety. The control group will receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and receiving a comprehensive list of domestic violence resources. Effectiveness of the MI intervention will be determined by increased self-efficacy, measured by the Domestic Violence Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the intervention will be assessed by an increase in participants' readiness-to-change, and extent of their involvement in a wide variety of self-help and coping activities over the follow-up period. If successful, this screening and intervention program will be translated to other clinical settings.


Condition Intervention
Self-efficacy
Behavioral: Motivational interviewing (MI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Is Motivational Interviewing an Effective Intervention for Women Coping With Intimate Partner Violence

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Self-efficacy [ Time Frame: Change from Baseline in Self efficacy at 6 months ] [ Designated as safety issue: No ]
    The Domestic Violence Coping Self-efficacy Measure by Benight et al (2004) was modified to measure self efficacy at baseline and 6-months post randomization


Secondary Outcome Measures:
  • Depression [ Time Frame: Change from Baseline in depression at 6 months ] [ Designated as safety issue: No ]
    Depression at baseline and 6-month follow-up was measured using the 10 item Center for Epidemiologic Studies Depression Scale (CES-D )


Enrollment: 305
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interviewing (MI) Behavioral: Motivational interviewing (MI)

MI is a "client-centered" counseling approach developed to deliver stage-tailored intervention messages using non-confrontational, supportive communication strategies. The client is encouraged to explore the barriers and facilitating factors associated with the behavior change. The interviewer's role is to guide the conversation and avoid use of conventional directive approaches (e.g., persuasion, providing information).

In this trial, a trained motivational interviewer meets individually with patients randomized to the intervention for one-hour at baseline, followed by four MI telephone follow up contacts at 1-, 2-, and 4-months post baseline.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Screens positive for IPV
  • Literate in either English or Spanish

Exclusion Criteria:

  • Less than 18 years of age
  • pregnant at time of screening and consent
  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: NCT01410669

Locations
United States, Iowa
Iowa City, Iowa, United States
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Audrey F Saftlas, PhD University of Iowa
Principal Investigator: Corinne Peek-Asa, PhD University of Iowa
  More Information

No publications provided

Responsible Party: Audrey F. Saftlas, MPH PhD, University of Iowa
ClinicalTrials.gov Identifier: NCT01410669     History of Changes
Other Study ID Numbers: 5R49CE000924-03
Study First Received: August 1, 2011
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Self-efficacy
Intimate partner violence
Randomized clinical trial
Depression

ClinicalTrials.gov processed this record on October 19, 2014