Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

The goal of this randomized clinical trial is to test an intervention consisting of a combination of behavioral couples therapy and motivational interviewing to improve communication and reduce conflicts between couples and decrease harmful drinking among spouses in urban primary health centers, South India. The intervention will be delivered by nurses in primary health centers who will be supervised by a clinical psychologist.

The main question\[s\] it aims to answer are:

* Do the wives of the couples in the intervention report less intimate partner violence (IPV) after 12 months, compared to wives in couples in a control group? * Do the husbands of the couples in the intervention show less alcohol consumption after 12 months, compared to husbands in couples in a control group? Husbands will participate in Motivational Interview (MI) sessions targeted at reducing their alcohol use. Husband and wife will participate in Behavioral Couples Therapy (BCT) targeted at improving their marital relationship.

These intervention participants will be compared to a control group who will receive only referral information for intimate partner violence and an educational session and referral for alcohol use disorder.

All participants will participate in quantitative interviews at baseline, and every three months thereafter, for a period of one year. In-depth qualitative interviews will be done with a subgroup of couples to try to understand how the intervention led to the observed outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

married couple with both spouses age ≥18;

living within the catchment area of the PHC (primary health center);

speaking Kannada or Hindi;

wife reporting any physical or sexual intimate partner violence (IPV) in the past 12 months (note exclusion for severe IPV below);

Disqualifiers

husband has severe alcohol dependency (per Severity of Alcohol Dependence Questionnaire, SADQ ≥ 31) or is at risk of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol Scale-Revised - CIWA-AR);

significant medical problems that will make the couple unable to participate in the intervention sessions;

cognitive problems (adapted Short-Blessed Cognitive Test score ≤7);

past year history of IPV severe enough to result in hospitalization (per an adapted version of the International Violence Against Women Survey - IVAWS), or 5) wife screens positive for any AUD (AUDIT-C >4).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT)

    Behavioral

    Four Motivational Interviewing sessions with the husband (wife joins for last MI session) to reduce alcohol use dependency, followed by six Behavioral Couples Therapy session with the husband and wife together to improve their relation and communication and reduce intimate partner violence. Session 1: couple establishes daily trust contract and discusses strategies to cope with reduced alcohol use. Session 2: couple revisits these coping skills and builds on additional strategies, as necessary. Session 3: they shift to improving the relationship and communication. Session 4: activity to promote caring behavior between partners. Session 5: couple reviews communication strategies learned previously, learn active listening and address any ongoing communication challenges. Session 6: review session and plans to address challenges to create long-term change.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Enhanced usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intimate Partner Violence: mean score on Indian Family Violence and Control Scale

The Indian Family Violence and Control Scale (IFVCS) will be administered to the wife only. The IFVCS is a 63-item scale measuring self-reported frequency of occurrence of control and psychological, physical, and sexual violence in the past year. The mean score ranges from 0 to 3 with higher scores indicating experience of more or more frequent intimate partner violence.

Time frame
baseline
2

Intimate Partner Violence: mean score on Indian Family Violence and Control Scale

The Indian Family Violence and Control Scale (IFVCS) will be administered to the wife only. The IFVCS is a 63-item scale measuring self-reported frequency of occurrence of control and psychological, physical, and sexual violence in the past year. The mean score ranges from 0 to 3 with higher scores indicating experience of more or more frequent intimate partner violence.

Time frame
6 months post baseline
3

Intimate Partner Violence: mean score on Indian Family Violence and Control Scale

The Indian Family Violence and Control Scale (IFVCS) will be administered to the wife only. The IFVCS is a 63-item scale measuring self-reported frequency of occurrence of control and psychological, physical, and sexual violence in the past year. The mean score ranges from 0 to 3 with higher scores indicating experience of more or more frequent intimate partner violence.

Time frame
12 months post baseline
4

Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score

Self-assessed alcohol use dependency (husband only) will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Each items is scored on a 0-4 scale and items scores are summed, resulting in a range from 0 to 40, with higher scores indicating greater alcohol use and dependency.

Time frame
baseline

Secondary outcomes

1

Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

The male participant will take a breathalyzer test every day for 7 consecutive days in the week prior to the questionnaire assessment, resulting in a count variable ranging from 0 to 7.

Time frame
baseline
2

Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

The male participant will take a breathalyzer test every day for 7 consecutive days in the week prior to the questionnaire assessment, resulting in a count variable ranging from 0 to 7.

Time frame
3 months post baseline
3

Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

The male participant will take a breathalyzer test every day for 7 consecutive days in the week prior to the questionnaire assessment, resulting in a count variable ranging from 0 to 7.

Time frame
6 months post baseline
4

Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

The male participant will take a breathalyzer test every day for 7 consecutive days in the week prior to the questionnaire assessment, resulting in a count variable ranging from 0 to 7.

Time frame
9 months post baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

St. John's Research Institute

Collaborator

RTI International

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator