Actively Recruiting

Phase Not Applicable
Age: 15Years - 24Years
All Genders
ID06834867

A Randomized Controlled Trial of a Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence (MILAP) Among Young Women in Nepal

Led by Possible · Updated on 2026-04-14

900

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

Sponsors

P

Possible

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of a family-based intervention called MILAP to reduce depression, intimate partner violence (IPV), and post-traumatic stress disorder (PTSD) among young married women in Nepal. IPV is a major health issue in low- and middle-income countries, often linked to mental health problems. This study focuses on how ongoing IPV and family dynamics, particularly involving mothers-in-law, impact young women's mental health and aims to evaluate MILAP's ability to improve outcomes and understand how it works. The MILAP intervention consists of nine sessions over nine weeks, involving the young woman, her husband, and mother-in-law. It starts with sessions for mothers-in-law and daughters-in-law to build support and empowerment, followed by sessions addressing depression with behavioral activation. Then, couples participate in behavioral therapy focusing on communication and trust. The final session includes the whole family to review lessons and prepare for challenges. The control group receives enhanced usual care with counseling and support services. Participants will be assessed at the start, after one month, and every three months up to one year using questionnaires covering depression, IPV, PTSD, and other mental health and social measures. Data collection includes interviews and surveys conducted in private settings. Researchers will analyze changes in depression, IPV, and PTSD, explore how the intervention works through mixed methods, and evaluate its cost-effectiveness. The study involves 300 families, each with a wife, husband, and mother-in-law, with half receiving MILAP and half receiving usual care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years - 24Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Married women aged 15-24 years, their husbands and mothers-in-law living in the same household
  • Living in the study area with no plans to leave during the study period
  • Speaking Maithili or Nepali languages
  • Wife reporting physical, sexual, or abusive control by her husband within the last 12 months
  • Desire to remain in the current relationship and family
Not Eligible

You will not qualify if you...

  • Pregnant women
  • History of intimate partner violence severe enough to require hospitalization in the past 12 months
  • Significant cognitive problems or disabilities that prevent participation
  • Severe alcohol dependence, defined as a high score on the Severity of Alcohol Dependence Questionnaire (SADQ > 31)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment and Enrollment

Duration - 1 day

Participants who consent complete baseline assessments separately for the wife, husband, and mother-in-law before randomization.

1 visit (in-person)

MILAP Intervention

Duration - 9 weeks

Participants in the intervention arm complete a 9-week multi-component behavioral intervention including sessions for mother-in-law and daughter-in-law, behavioral activation for depression, and couples therapy for the wife and husband, concluding with a family session.

Weekly visits for up to 9 weeks

Enhanced Usual Care

Duration - Ongoing during trial period

Participants in the control arm receive enhanced usual care including safety assessments, IPV rehabilitation services, educational materials, and referrals to support services as needed.

Visits as needed for care

Follow-up Assessments

Duration - 12 months

Blinded research staff conduct assessments to measure depression, intimate partner violence, PTSD symptoms, and other outcomes at multiple timepoints after baseline.

Assessments at 1 month, and every 3 months up to 12 months (6 visits total)

Trial Site Locations

Total: 1 location

1

Possible

Kathmandu, Bagmati, Nepal

Actively Recruiting

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Research Team

B

Bibhav Acharya, MD

S

Sabitri Sapkota, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Interventions for reducing and/or controlling domestic violence among pregnant women in low- and middle-income countries: a systematic review.

Diksha Sapkota, Kathleen Baird, Amornrat Saito...

https://pubmed.ncbi.nlm.nih.gov/30940204

Gender-based violence and suicidal ideation among Indian women from slums: An examination of direct and indirect effects of depression, anxiety, and PTSD symptoms.

Anushka R Patel, Shraddha Prabhu, Nicole A Sciarrino...

https://pubmed.ncbi.nlm.nih.gov/33507794

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.

Mina Shrestha, Elsa Heylen, Kripa Sigdel...

https://pubmed.ncbi.nlm.nih.gov/41680806

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.

Mina Shrestha, Elsa Heylen, Kripa Sigdel...

https://pubmed.ncbi.nlm.nih.gov/40964025