A Combined Motivational Interviewing and Behavioral Couples Therapy Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Intimate Partner Violence: mean score on Indian Family Violence and Control Scale
研究概览
简要总结
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.
详细描述
Aim 1: PILOTING. Prior to launching the trial, 10 male and 10 female participants will pilot test any measures that need to be adapted for this study and complete cognitive interviews. The study team and stakeholders then review the pilot data and finalize the measures. The investigators finalize and refine the intervention protocol based on direct observation of nurses delivering it to research staff. Mock sessions will be observed to ensure protocol fidelity when MI and BCT are delivered sequentially. Training manuals, guides, fidelity checklists and trainers are already available from previous studies. For MI, Motivational Interviewing Treatment Integrity (MITI) coding is used; for BCT, a standard checklist from a pilot study, to document proportion of relevant topics covered in each session and the quality of counseling, interaction with participants to assess engagement with the material, and any factors that may have affected implementation.
Aim 2: RANDOMIZED CONTROLLED TRIAL: 400 married couples will be recruited from government-run urban primary health centers (PHCs). Community health workers, called ASHAs (Accredited Social Health Activists) in India, refer couples they know are experiencing intimate partner violence (IPV) while the husband uses alcohol. ASHAs bring the woman to the clinic for a routine "women's health" appointment in which research staff screen the woman for eligibility, after obtaining informed consent. If the woman is eligible (criteria see elsewhere), she is asked if her husband drinks alcohol. If yes, the study staff member determines the appropriate method for engaging her husband (wife brings him, study calls him directly, or ASHA speaks with him).
In the next visit for the couple, the research team obtains screening consent of the husband and assess his eligibility (criteria see elsewhere). For all patients who are ineligible for the study but screen positive for IPV or AUD (alcohol use disorder), study staff will provide a brief educational session on AUD (to applicable participants) and immediately refer all of them to NIMHANS in Bangalore, a premier tertiary care system that can address IPV issues, psychology and psychiatry services, as well as de-addiction for severe alcohol dependence and alcohol withdrawal. After confirming that the couple is eligible and interested, the research staff obtains consent to participate in the trial, enroll them in the study and, if randomized to the intervention arm, schedule the first session with the study. Participants are randomized at the couple level, prior to the start of the intervention.
Participants in the intervention arm receive 4 weekly 1-hour Motivational Interviewing (MI) sessions (#1-3 for husband only, #4 for couple), followed by six weekly 1-hour Behavioral Couples Therapy (BCT) sessions; all are delivered by a trained study nurse and occur in person - details elsewhere.
Participants in the control arm receive enhanced usual care, since usual care for IPV and AUD in PHCs is limited and even when protocols exist, they are not usually followed. Enhanced usual care includes: a) trained staff conduct initial safety assessments for all patients; b) for IPV, wives are referred to a tertiary care center (NIMHANS), and informed of their options and local resources; c) for AUD, participants receive a brief educational session and referral to NIMHANS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medical care providers at the recruitment site will be blinded to intervention arm. The intervention and assessment study staff do not overlap and all reasonable care is taken to keep assessment staff blinded to intervention allocation for the whole duration of the study. Investigators know intervention arm on a need to know basis but do not have contact with participants directly.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •the husband having Alcohol Use Disorder (AUD) measured by AUDIT-C (AUDIT-C ≥4).
排除标准
- •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).
研究组 & 干预措施
Intervention
Four sessions with husband containing standard primary care based Motivational Interviewing techniques to reduce AUD in community populations. Wife joins 4th session on relapse prevention and support. This is followed by six Behavioral Couples Therapy sessions - see intervention description for content. All sessions are weekly, 1 hour in duration, delivered in person by a trained study nurse and include role plays and assignments to practice between sessions. Comic strips and graphics reinforce lessons and skills taught throughout the sessions.
干预措施: Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT) (Behavioral)
Enhanced usual care
For ethical reasons, to ensure participants in the control arm receive care for IPV and AUD, a) trained staff will conduct initial safety assessments for all patients; b) for IPV, wives will be referred to a legal cell at NIMHANS, a one-stop IPV center, and given information re. their options and local resources such as contact information for local organizations that can provide legal advice, counseling, and shelters; c) for AUD, participants will receive a brief educational session based on the World Health Organization's (WHO) manual for managing AUD in PHCs and referral to NIMHANS, a tertiary care mental health and addictions treatment center that has a dedicated referral system with the PHCs.
结局指标
主要结局
Intimate Partner Violence: mean score on Indian Family Violence and Control Scale
时间窗: 12 months post baseline
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.
Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score
时间窗: 12 months post baseline
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.
次要结局
- Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days(12 months post baseline)
- Communication skills: mean subscale score for positive and negative communication on the Communications Patterns Questionnaire(12 months post baseline)