Mental Health

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

TL;DR

This paper presents a study protocol for a randomized controlled trial evaluating a Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP) among young married women in Nepal, enrolling 300 family triads comprising a young married woman, her husband, and her mother-in-law.

Key Findings

IPV approximately doubles the prevalence of depression, establishing it as a well-established driver of mental health problems.

  • The paper states 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
  • Young women are disproportionately affected by mental health issues related to IPV
  • This epidemiological context motivated the development of the MILAP intervention

The MILAP RCT will enroll 300 family triads, each comprising a young married woman aged 15-24, her husband, and her mother-in-law.

  • Each triad will be randomly assigned to either MILAP or enhanced usual care (EUC)
  • Blinded staff will conduct baseline assessments prior to randomization
  • The trial is registered in ClinicalTrials.gov with NCT number NCT06834867, first registered on February 24, 2025
  • The study is set in Nepal, a low- and middle-income country context

MILAP comprises nine sessions delivered by trained psychosocial counselors and focuses on three core components: strengthening MIL-DIL relationships, providing behavioral couples therapy, and enhancing overall family dynamics.

  • Sessions are delivered by trained psychosocial counselors
  • The intervention specifically focuses on 'strengthening the supportive relationship between MILs and daughters-in-law (DILs)'
  • Components include behavioral couples therapy and enhancement of overall family dynamics
  • The intervention is described as 'culturally adapted' and 'family-based'
  • MILAP aims to improve communication, strengthen coping skills, and foster supportive family relationships

The enhanced usual care (EUC) control condition includes standard individual and group counseling for IPV, augmented with crisis counseling and referral support.

  • EUC includes 'standard care, such as individual and group counseling for IPV'
  • EUC is 'enhanced with crisis counseling and referral support to ensure participant safety and access to additional resources'
  • All participants regardless of allocation will be assessed at baseline and at 1-, 3-, 6-, 9-, and 12-month follow-ups
  • The inclusion of crisis support in the control arm reflects ethical considerations for participant safety

The trial's primary outcomes are depression measured by the Patient Health Questionnaire-9 (PHQ-9) and IPV measured by the Indian Family Violence and Control Scale.

  • Depression is measured using the Patient Health Questionnaire-9 (PHQ-9)
  • IPV is measured using the Indian Family Violence and Control Scale
  • Secondary outcome includes post-traumatic stress disorder (PTSD) measured using the PTSD CheckList-Civilian Version
  • Assessments occur at six time points: baseline and 1-, 3-, 6-, 9-, and 12-month follow-ups

The trial includes serial in-depth interviews and a cost-effectiveness analysis as additional components to assess mechanisms and scalability.

  • Serial in-depth interviews will 'explore the mechanisms underlying MILAP's effectiveness'
  • A cost-effectiveness analysis will 'assess its potential for scalable implementation'
  • The study aims to assess 'MILAP's effectiveness, ethical rigor, cultural relevance, and scalability'
  • The explicit goal includes 'reducing IPV and improving family dynamics in low- and middle-income settings'

Mothers-in-law (MILs) were identified as a key target for intervention inclusion because they can influence violence and restrict women's mobility in Nepali households.

  • The paper notes that 'many women in Nepal reside with their mothers-in-law (MILs)'
  • MILs 'can influence violence and restrict women's mobility'
  • This co-residence pattern 'highlight[s] the importance of including them in interventions targeting IPV'
  • Including MILs as a triad member is a distinguishing design feature of MILAP compared to interventions targeting only couples

What This Means

This research describes the design of a clinical trial testing a new family-based program called MILAP (Multi-component family Intervention to Lower depression and Address intimate Partner violence) in Nepal. The program is unique because it involves not just married couples but also mothers-in-law, who commonly live with young married women in Nepal and can play a significant role—either positive or negative—in whether violence occurs at home. The trial will recruit 300 sets of three family members (a young woman aged 15–24, her husband, and her mother-in-law) and randomly assign them to either the nine-session MILAP program or an enhanced standard care program. Participants will be followed for one year to see whether MILAP reduces depression and intimate partner violence more effectively than the comparison program. This research suggests that addressing intimate partner violence and depression in Nepal may require going beyond working with couples alone. Because approximately one in four women in Nepal experience intimate partner violence, and because IPV can double the risk of depression, there is a significant public health need for effective, culturally appropriate interventions. MILAP was specifically designed to improve communication, build coping skills, and strengthen supportive relationships within the family unit, including with mothers-in-law. The trial will also examine whether the program is cost-effective, which is important for determining whether it could be adopted more widely across Nepal and similar settings. The study will also include in-depth interviews to understand how and why the program works (or doesn't), and will track post-traumatic stress disorder (PTSD) as an additional health outcome. By testing this approach in a rigorous randomized controlled trial with multiple follow-up points over 12 months, the researchers aim to generate evidence that could inform policy and scaling of family-based violence prevention programs in low- and middle-income countries.

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Citation

Shrestha M, Heylen E, Sigdel K, Dhimal M, Nepal P, Pant P, et al.. (2026). A multi-component family intervention to lower depression and address intimate partner violence (MILAP) among young married women in Nepal: a study protocol for a randomized controlled trial.. Trials. https://doi.org/10.1186/s13063-026-09507-8