Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence in Nepal

Intimate Partner Violence (IPV), defined as control, psychological, physical, and sexual violence by a close partner, is a major public health problem in low- and middle-income countries (LMICs) with one in three women experiencing IPV in their lifetime. National prevalence in Nepal, this study's research site, is 25% for IPV and 12% for depression. IPV is a well-established driver of mental health (MH) problems, doubling the rate of depression via feelings of worthlessness, disempowerment, amotivation, social isolation and marital strain, and increasing the incidence of post-traumatic stress disorder (PTSD) via trauma, increased fear and anxiety. The association between IPV and MH problems is well- documented in South Asia, with 25-50% of women with IPV reporting depressive symptoms and an increase in rates of PTSD.

Several meta-analyses have highlighted the lack of interventions to reduce IPV and improve MH in LMICs. A major challenge is that despite ongoing IPV, young women in LMICs are less likely to have the ability and/or desire to undergo divorce or separation. This substantially limits the impact of available interventions such as CBT (cognitive behavioral therapy), which has been found to improve depression among women who have already exited relationships that led to IPV. Review articles have thus concluded that there is a significant gap in behavioral interventions that can improve outcomes for women who are currently experiencing abuse. Thus, a culturally appropriate evidence-based intervention is needed to enhance MH recovery while simultaneously reducing IPV.

Many women in LMICs live in multi-generational households, where the drivers of IPV and MH include not just the husband, but often the mother-in-law (MIL). There is evidence that MILs play a substantial role in restricting or supporting the daughter-in-law's (DIL's) Freedom of Movement (FOM), as young women (age 15-24) move into their husband's home. Combined with the evidence that MILs also affect IPV or perpetrate direct violence, they have a critical role in driving or mitigating the complex relationship between IPV and MH. Despite this, majority of IPV and MH interventions involve only the women experiencing IPV, and rarely also their husbands, but not the whole family unit.

This study's investigators developed and pilot-tested a novel Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP, meaning unity and reconciliation in Nepali) among young married women in Nepal. MILAP engages three members (triads) of each family, i.e wives (also frequently referred as daughter-in-laws(DILs) throughout the description), and their husbands and MILs. MILAP's first component engages DILs and their MILs by establishing them as allies in addressing IPV and improving DIL's empowerment and freedom of movement. In MILAP's second component, the wife and husband participate in behavioral couples therapy (BCT) to improve communication skills, increase caring behaviors, and enhance trust in the marital relationship. This approach was highly acceptable to the participants as the intervention focused on skills-building and relationships rather than explicitly dealing with the stigmatizing topics of IPV and mental health. The intervention was found to be safe and feasible, and resulted in substantial reduction in proportion of people with moderate depression and frequency of IPV. Based on this pilot study, the investigators now propose to conduct a randomized controlled trial (RCT) of MILAP to establish intervention's effectiveness, understand mechanism of intervention impact, and conduct a costing analysis. Additionally, the investigators aim to understand the processes via which MILAP addresses IPV-related drivers of MH. For this, the investigators will conduct a mixed-methods explanatory assessment of the MILAP's theorized mechanisms of change by combining data from quantitative and qualitative assessments. Finally, the investigators will conduct a cost-effectiveness analysis of MILAP for depression and IPV to estimate the health and economic benefits of investing in delivering MILAP. This analysis will use programmatic and financial data to perform a comprehensive analysis of costs incurred in providing MILAP. The purpose of this analysis is to assist policymakers/payors in assessing MILAP for potential investment by providing: a) assessment of average costs to deliver MILAP for each family (triad); b) estimation of incremental average costs for MILAP over enhanced usual care per family (triad); and c) disaggregation of costs in delivering MILAP's components (MilDil and BCT).

This study will include family units (triads) which will be randomized 1:1 to the intervention group and control group. The study will involve 900 participants from 300 triads (wife, her husband and MIL) where 150 triads will be assigned to intervention group and 150 triads will be assigned to control group. The mobilized community health workers (CHWs) will refer potential candidates from the community to recruitment sites where the staffs will screen the referred individuals for eligibility. Research staff trained by investigators will conduct initial screening for presence of IPV using a screening tool adapted from International Violence Against Women Survey (IVAWS). Initial screening will be made in community-based organizations and women's groups, which are well-attended and hosted by our community-based partner organization, Women's Rehabilitation Centre (WOREC)'s offices. If the woman (wife) meets the criteria, she will be asked to provide permission for the research team to approach her husband and MIL about participating in the study. If her response is positive, she will be asked to choose the most appropriate way to engage her husband and MIL: a) she will bring them to the next visit; or b) the research staff will call them directly and ask them to come to the recruitment location; or c) the CHWs will approach the husband and MIL at their home. After verbal consent with all three members of the family (consent will be obtained from each member separately), the research staff will engage participants in the written informed consent process, which will also happen individually for each of the 3 family members. After the consent process, the research staff will conduct baseline assessments with the wive, husband and MIL participants separately. Then, the research staff will randomly assign the triads to intervention or control arm. Prior to the start of the intervention, a statistician not directly involved with the implementation of the study will draw up a computer generated "random order of assignment" list. These random assignments will be placed in advance in sealed, numbered envelopes, so research staff is not aware of the upcoming assignment. At the end of the baseline assessment session, the randomization assignment will be revealed to the triad by drawing the next available envelope in their presence. Assessment staff will be blinded from allocation status. Enhanced usual care will be delivered by WOREC-based counselors (called "psychosocial counselors", and widely available in Nepal) who will not be trained in intervention components. The intervention i.e. MILAP will be delivered by research counselors, who will be trained and supported by the research team.

Blinded research staff will conduct assessments at baseline (after obtaining consent), at 1 month (between MilDil and BCT) and every 3 months until 1-year follow-up. Based on the pilot studies, the investigators estimate that assessments will last between 45-75 minutes (longer for the wives as they will complete more assessments). Research staff will collect contact information at baseline and update it at follow-ups. Staff will receive training and certification on interviewing and assessments, strategies to reduce social desirability bias, avoid questions that may reveal if the participant is in the intervention or control arm, and follow human subjects protections and the study protocol. All assessments will be conducted in local languages and in a private room at the WOREC's office, or at a different mutually convenient location that provides privacy. Responses will be entered into a tablet-based version of Research Electronic Data Capture (REDCap). This study will use following tools to collect data from participants:

1. Demographic Information - Age, education, languages spoken, religion, income, caste, migrant status, marital status and number of months since wedding date 2. Adverse Childhood Experiences: 8 items each on witnessing and experiencing adverse childhood events. For MIL, additional questions from IVAWS on history of experiencing IPV 3. Patient Health Questionnaire-9 (PHQ-9): 9-items scale to measure depression among women participants 4. Indian Family Violence and Control Scale (IFVCS): 63-items tool to measure abusive control, psychological, physical and sexual violence perpetrated by an intimate partner 5. Post Traumatic Stress Disorder (PTSD) Checklist -Civilian Version (PCL-C): 17-itemed self-report rating scale for PTSD 6. Women's Autonomy Scale: 5 itemed tool to measure women's ability to move outside the household unescorted 7. Gender Equitable Men Scale (GEMS): 4-item, 3-point response subscale pertaining to IPV 8. Anxiety Sensitivity Scale (ASI): 16 items to assess perceived threat level 9. Fear Survey Schedule (FSS): Subscale for injury and sex aggression fears 10. Spousal Quality Relationship Scale (SQRS): 21 items on commitment, trust and satisfaction between partners; MILRQS: 7 items on MIL-DIL relationship 11. Behavioural Activation and Depression Scale - Short Form (BADS-SF): 9 items to assess withdrawal from or engagement in rewarding activities 12. Rosenberg Self Esteem Scale (RSES): 10 items to globally self-worth by measuring positive and negative feelings about self 13. Sexual Relationship Power Scale (SRPS): 8 items subscale for decision making power in the relationship 14. World Health Organization Quality of Life-BREF (WHOQOL-BREF): 9 items on psychological well-being and social functioning 15. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): 16-item tool to measure health and disability across cultures. 16. General Anxiety Disorder (GAD-7): 7 items to screen generalized anxiety disorder

Qualitative data will be collected twice from \~15% (n=66 participants based on the resource availability and expected number to reach thematic saturation at 22 triads) of the intervention arm sample, through serial in-depth interviews (IDIs). Triads will be purposively selected based on variation in engagement with MILAP intervention activities. All IDIs will follow a semi-structured guide and will be implemented by experienced staff members fluent in local languages and trained in safety and response procedures. Serial IDIs will be conducted at two timepoints: at the end of MILAP intervention and at the 12-month follow up visit.

The effectiveness of MILAP to reduce the proportion of women (DILs) with moderate to severe depression (primary outcome), levels of IPV (primary outcome), and PTSD (secondary outcomes) significantly more than enhanced usual care will be assessed via intention-to-treat (ITT) regression analyses at the end of the trial (12-month follow-up, a single timepoint), as well as longitudinally via the interaction between intervention arm and time in a two-level regression model with repeated measures nested within participants (=DIL) and a random intercept for participants. This will be a logistic regression model for the binary depression outcome, and a linear model for the continuous IPV (IFVCS score) and PTSD (PCL-C score) outcomes.

The investigators will conduct a mixed-methods explanatory assessment of the intervention's theorized mechanisms of change by combining data from the full cohort of quantitative assessments and from serial IDIs with 22 fam

• Post-traumatic Stress Disorder (PTSD) Symptom Severity [Time frame: Assessments at baseline, and at 1, 3, 6, 9, and 12 months follow-ups.]