Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence in Nepal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorPossible
About this trial
Intimate Partner Violence (IPV) is a major public health problem in low- and middle-income countries (LMICs). Globally, an estimated 30% of women report physical or sexual violence by an intimate partner in their lifetime. IPV is a well-established social driver of mental health problems, and doubles the rate of depression and post-traumatic stress disorder (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression after women experiencing IPV exit abusive relationships. However, despite ongoing violence, many young women in LMICs are less likely to divorce or separate from their husband. But ongoing IPV severely limits mental health recovery and increases the risks of suicide. Another important factor in many LMICs is that young women often live in extended, multi-generational households, where studies have shown that mother-in-laws (MILs) play a critical role in young married women's autonomy and freedom of movement, substantially affecting her mental health. The pathways via which multiple family members and ongoing IPV affect young women's mental health in LMICs is very poorly understood. There is an urgent need to design and assess interventions that: a) improve mental health and reduce IPV; b) engage husbands and MILs, and not just women experiencing IPV; and c) elucidate pathways via which IPV-related drivers affect mental health.
This study's research team, with over 16 years of experience in Nepal, conducted a pilot study introducing the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP). MILAP, which translates to "unity and reconciliation" in Nepali, showed promise in reducing depression and IPV among families (comprising women, husbands, and mothers-in-law). Based on these favorable results, the investigators now propose a 12-month randomized controlled trial (RCT) to assess the effectiveness of MILAP in addressing depression, IPV, and PTSD among young married women in Nepal. The goal of this RCT is to assess the effectiveness of MILAP, understand mechanisms of change for MILAP's effectiveness, and conduct a cost-effectiveness analysis. The specific aims of this study are:
AIM 1: Conduct a 12-month RCT to assess the effectiveness of MILAP on depression, IPV, and PTSD among young married women in Nepal.
AIM 2: Conduct a mixed-methods assessment of theorized mechanisms of change for MILAP's effectiveness.
AIM 3: Conduct a cost-effectiveness analysis of MILAP for depression and IPV.
Participants of this study will receive either MILAP or enhanced usual care, and will answer questions about depression, IPV and PTSD at baseline, at 1 month and every 3 months until 1-year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Married women aged 15-24 years, their husbands and MILs sharing a household;
Living in the catchment area with no stated intention of leaving during the study period;
Participants speaking in Maithili or Nepali;
Wife reporting Intimate Partner Violence (physical, sexual or abusive control) in last 12 months as measured by three questions from the International Violence Against Women Survey (IVAWS);
Disqualifiers
Pregnant women;
History of IPV severe enough to result in hospitalization in the past 12 months;
Significant cognitive problems/disability precluding participation;
Any participant with Severe Alcohol Dependence, defined as Severity of Alcohol Dependence Questionnaire (SADQ) > 31 (those with mild to moderate dependance will be referred but not excluded)
Trial design
Design model
Parallel
Treatments tested in this trial
MILAP intervention
BehavioralThe MILAP intervention, developed through participatory research, includes 9 sessions over 9 weeks, totaling 11 hours. It begins with the MilDil component, consisting of two sessions (4 hours) for MIL-DIL dyads, focusing on discussing cultural gender norms, raising awareness about the negative impact of IPV, establishing allyship between MIL and DIL, and empowering DILs while enhancing MILs' support for DILs' freedom of movement. This is followed by two one-hour sessions on Brief Behavioral Activation (BA) to address and prevent depression, involving MILs for necessary family support. Lastly, the husband-wife dyad will engage in four weekly sessions (4 hours) of Behavioral Couples Therapy (BCT), aimed at improving communication, coping strategies, and fostering caring behaviors between partners.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual CareNo intervention 0 interventions
Group B: MILAP InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of women who have moderate to severe depression
Patient Health Questionnaire (PHQ-9) is a widely used instrument for screening, diagnosing, and monitoring the severity of depression. It consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), with a total possible score ranging from 0 to 27. Higher scores reflect greater severity of depressive symptoms, making the PHQ-9 a valuable tool for assessing the impact of interventions on depression levels. This study will use PHQ-9 score as continuous variable and assess proportion of women whose PHQ-9 score is greater than 9 at 12-month follow-up
Time frame
Assessments at baseline, and at 1, 3, 6, 9 and 12 months follow-ups.2
Abusive control, physical violence, and sexual violence/coercion
This study will measure abusive control, physical violence, and sexual violence/coercion using the Indian Family Violence and Control Scale (IFVCS), which is specifically designed to assess and quantify various forms of violence and controlling behaviors within family contexts. It includes 75 items on physical, emotional, and financial abuse, along with behaviors aimed at exerting control, particularly within marital relationships. This study will use 63 items, out of total 75 items, that are relevant to the study outcomes. Higher score explains high control and violence over women. The score ranges from 14 to 56.
Time frame
Assessment at baseline, and at 1, 3, 6, 9, and 12 months follow-upsSecondary outcomes
1
Post-traumatic Stress Disorder (PTSD) Symptom Severity
This study will assess post-traumatic stress disorder (PTSD) symptom severity using the PTSD Checklist - Civilian Version (PCL-C). It is a 17-items self-rated measure that assesses PTSD symptom severity based on the DSM-4 PTSD criteria. The score ranges from 17 to 85. Higher score explains higher level of stress.
Time frame
Assessments at baseline, and at 1, 3, 6, 9, and 12 months follow-ups.Sponsors and contacts
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Possible
Lead sponsor
University of California, San Francisco
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Wheaton College
Collaborator
Women's Rehabilitation Centre (WOREC)
Collaborator
Source ClinicalTrials.gov