Actively Recruiting
A Combined Motivational Interviewing and Behavioral Couples Therapy Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India
Led by University of California, San Francisco · Updated on 2025-07-04
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
S
St. John's Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined behavioral couples therapy and motivational interviewing intervention aimed at improving communication and reducing intimate partner violence (IPV) and harmful alcohol use among married couples in urban primary health centers in South India. The study focuses on wives experiencing IPV and husbands with alcohol use disorder (AUD), comparing outcomes between couples receiving the intervention and those receiving enhanced usual care. This randomized clinical trial includes 400 couples to assess effects over 12 months. The intervention group participates in four weekly one-hour Motivational Interviewing sessions with the husband (the wife joins the fourth session), followed by six weekly one-hour Behavioral Couples Therapy sessions with both spouses. These sessions are delivered in person by trained nurses and include role plays, homework assignments, and supportive materials. The control group receives safety assessments, referral information, and brief educational sessions for IPV and AUD. Before the trial, pilot testing and protocol refinement are conducted to ensure fidelity to the intervention. Participants complete quantitative interviews and breathalyzer tests at baseline and every three months for one year. Assessments cover alcohol use, IPV, communication skills, and related psychological and social factors. A subgroup of couples participates in in-depth interviews to explore how the intervention influences outcomes. Researchers measure primary outcomes using the Indian Family Violence and Control Scale for IPV and AUDIT scores for alcohol use. Secondary outcomes include communication patterns and breathalyzer results. Data analysis will compare trajectories between groups to evaluate the intervention's impact.
CONDITIONS
Brief Title
Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Married couples with both spouses aged 18 years or older
- Living within the catchment area of the primary health center
- Speaking Kannada or Hindi
- Wife reports any physical or sexual intimate partner violence in the past 12 months
- Husband has Alcohol Use Disorder as measured by AUDIT-C score of 4 or higher
You will not qualify if you...
- Husband has severe alcohol dependency (Severity of Alcohol Dependence Questionnaire score of 31 or higher) or risk of severe withdrawal symptoms
- Significant medical problems preventing participation in intervention sessions
- Cognitive problems (Short-Blessed Cognitive Test score less than 7)
- Past year history of severe intimate partner violence resulting in hospitalization
- Wife screens positive for Alcohol Use Disorder (AUDIT-C score greater than 4)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening the wife and 1 visit (in-person) for screening the husband
Duration - 10 weeks
Participants randomized to the intervention arm receive four weekly 1-hour Motivational Interviewing sessions (first three sessions with the husband only and the fourth session with both husband and wife), followed by six weekly 1-hour Behavioral Couples Therapy sessions with both partners to improve their relationship, communication, and reduce intimate partner violence. Participants in the control arm receive enhanced usual care including safety assessments, educational sessions, and referrals.
Weekly visits for 10 weeks (4 sessions of Motivational Interviewing and 6 sessions of Behavioral Couples Therapy) for intervention arm; control arm receives initial assessment and educational session(s)
Duration - 12 months
Participants complete quarterly assessments including tablet-administered questionnaires and a 1-week breathalyzer test to measure alcohol use and intimate partner violence outcomes.
Quarterly visits for follow-up assessments over 12 months with breathalyzer use at home for 1 week prior to each visit
Trial Site Locations
Total: 1 location
1
St. John's Research Institute
Bangalore, Karnataka, India
Actively Recruiting
Research Team
M
Maria L Ekstrand, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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