A randomized controlled trial of a multi-component family intervention to lower depression and address intimate partner violence (MILAP) among young married women in Nepal: a study protocol.

Background: Intimate Partner Violence (IPV) is a well-established driver of mental health problems, often doubling the prevalence of depression. In Nepal, approximately one in four women experience IPV, with young women disproportionately affected by mental health issues. Many women in Nepal reside with their mothers-in-law (MILs), who can influence violence and restrict women's mobility, highlighting the importance of including them in interventions targeting IPV. To address this, we developed a Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP) and will conduct a randomized controlled trial (RCT) to evaluate its effectiveness in reducing IPV and depression. Methods: This RCT will enroll 300 family triads, each comprising of a young married woman (aged 15-24), her husband, and her MIL. Blinded staff will conduct baseline assessments, after which each triad will be randomly assigned to either the MILAP or Enhanced Usual Care (EUC). MILAP comprises nine sessions delivered by trained psychosocial counselors and focuses on strengthening the supportive relationship between MILs and daughters-in-law (DILs), providing behavioral couples therapy, and enhancing overall family dynamics. EUC includes standard care, such as individual and group counseling for IPV, enhanced with crisis counseling and referral support to ensure participant safety and access to additional resources. All participants, regardless of intervention allocation, will be assessed at baseline and at 1, 3, 6, 9, and 12-month follow-ups. These assessments will measure: primary outcomes [depression using Patient Health Questionnaire-9; IPV using Indian Family Violence and Control Scale], secondary outcome [post-traumatic stress disorder (PTSD) using PTSD CheckList-Civilian Version], and other outcomes. We will also conduct serial in-depth interviews to explore the mechanisms underlying MILAP's effectiveness and perform a cost-effectiveness analysis to assess its potential for scalable implementation. Discussion: MILAP is a culturally adapted, family-based intervention designed to reduce IPV and depression among young Nepali women by improving communication, strengthening coping skills, and fostering supportive family relationships. This trial will assess MILAP's effectiveness, ethical rigor, cultural relevance, and scalability, with the goal of reducing IPV and improving family dynamics in low- and middle-income settings. Trial registration: This trial is registered in ClinicalTrials.gov with the National Clinical Trial (NCT) number: NCT06834867; first registered on February 24, 2025.