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Motivational Interviewing Intervention for Intimate Partner Violence (ISIS)

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ClinicalTrials.gov Identifier: NCT01410669
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Self-efficacy Behavioral: Motivational interviewing (MI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Is Motivational Interviewing an Effective Intervention for Women Coping With Intimate Partner Violence
Study Start Date : December 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Self-efficacy [ Time Frame: Change from Baseline in Self efficacy at 6 months ]
    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 :
  1. Depression [ Time Frame: Change from Baseline in depression at 6 months ]
    Depression at baseline and 6-month follow-up was measured using the 10 item Center for Epidemiologic Studies Depression Scale (CES-D )



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Audrey F. Saftlas, MPH PhD, University of Iowa
ClinicalTrials.gov Identifier: NCT01410669     History of Changes
Other Study ID Numbers: 5R49CE000924-03 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011

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