Intimate Partner Violence Prevention in Nepal

December 12, 2018 updated by: Cari Clark, Emory University

Change Starts at Home: A Cluster Randomized Controlled Trial of a Media and Community Engagement Behavior Change Strategy to Prevent Intimate Partner Violence in Nepal

Introduction: Change Starts at Home (Change) is a multi-component social behavior change communication and community engagement strategy designed to prevent intimate partner violence (IPV), a significant public health issue in Nepal and throughout the world.

Methods and analysis: The study uses a concurrent mixed-methods design. The quantitative aspect of the evaluation is a pair-matched, repeated cross-sectional 2-armed, single-blinded cluster trial (RCT: N=36 clusters, 1440 individuals), comparing a social behavior change communication (SBCC) strategy to radio programming alone for its impact on physical and / or sexual IPV at the end of programming (12 months' post-baseline) and 6-months post the cessation of project activities (24-months post baseline). The qualitative aspects of the design include several longitudinal approaches to understand the impact of the intervention and examine mechanisms of change including in-depth interviews with participants (N=18 couples), and focus group discussions with community leaders (N=3 groups), and family members of participants (N=12 groups). Treatment effects will be estimated with generalized logistic mixed models specified to compare differences in primary outcome from baseline to follow-up, and baseline to 24-months post following intention-to-treat principles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Change Starts at Home intervention is a multi-component social behavior change communication (SBCC) strategy designed to shift attitudes, norms and behaviors that underpin the power imbalances between men and women and the perpetration of intimate partner violence (IPV) among couples in Nepal. Recognizing the social ecology of change, the intervention engages actors across multiple rings of influence, such as family members and community leaders, in addition to the primary target audience of married reproductive age women and their husbands. As an SBCC strategy, the intervention approaches intimate partner violence prevention through three key approaches: advocacy, social mobilization and behavior change communication.

Married couple participants will be asked to interact with a radio program and participate in weekly, sex-separate listening and discussion groups (LDG) that each last for between 75 and 120 minutes over the course of 9 months. The same participants will be invited to participate in workshops and community activities such as theater and town hall meetings. Female LDG members will be asked to take a survey three times over the course of 24 months. Family members of LDG members in the treatment condition will be asked to interact with a radio program, and attend up to two focus group discussions (FGD) to understand the environmental facilitators and constraints to the couple exhibiting more gender equitable attitudes and behaviors and changes in family-based norms. Family members will be invited to attend one LDG meeting every 3 months, street theaters and community meetings. Community leaders will be asked to interact with a radio program, to participate in a workshop, to develop a plan of action to promote gender equity and the reduction of violence, to jointly run a community event with an LDG in their area and to attend up to two FGDs. At three separate time points, a randomly selected sample of female community members meeting inclusion criteria will be invited to take a survey.

Study Type

Interventional

Enrollment (Actual)

4677

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Female survey participants

  • Of reproductive age (between 18-49 years)
  • Husband is at least 18 years of age
  • Both the wife and husband reside regularly in the study area
  • The wife and husband live together

Family Members

  • At least 18 years of age
  • A family member of a Listening and Discussion Group member

Community Leaders

  • At least 18 years of age
  • Considered to be in a position of authority or influence within the study communities per the recommendation of other community stakeholders

Listening and Discussion Group facilitators

  • Have a 12th grade standard academic qualification or better
  • Be living with his/her spouse
  • Have good communication skills
  • Have a good reputation in the community based on feedback from local social mobilizers
  • Able to commit to 9 months of programming and weekly reporting

Exclusion Criteria:

  • Participants must be able to communicate in Nepali
  • Must not be have plans to relocate in the coming 2 years
  • A physical or cognitive impairment that precludes participation for the duration requested by activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radio Program
Married couple participants will be asked to interact with a radio program and participate in weekly, sex-separate listening and discussion groups (LDG) that each last for between 75 and 120 minutes over the course of 9 months.
Behavioral: Behavior Change Communication
9-month weekly episode behavior change radio drama with interactive voice response (IVR)/short message service (SMS) listener engagement
Behavioral: Community Mobilization
Listening and discussions groups, 2 male and 2 female groups per study site meet weekly for 39 weeks and will receive training on gender equity, intimate partner violence (IPV), life skills, community mobilization, non-violent conflict resolution for listening and discussion group (LDG) facilitators to support knowledge and skill set acquisition of LDG members. There will be a joint couple's session every month to foster mutual learning and understanding in addition to community mobilization incentives led by LDGs and encouragement of family members of LGD members to listen to the radio and attend LDG sessions once every 3 months. Participants will also receive awareness raising and street theater to engage families and community members.
Behavioral: Advocacy
Training and 6-month follow up of religious/community leaders and religious leaders support community mobilization activity of local listening and discussion group (LGD).
Other: Control
The control group participants will be exposed to the radio program only, and will not participate in the LDGs, nor will they or their family members participate in the workshops and community activities.
Behavioral: Behavior Change Communication
9-month weekly episode behavior change radio drama with interactive voice response (IVR)/short message service (SMS) listener engagement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Prevalence of Physical and/or Sexual Intimate Partner Violence Encounters
Time Frame: Baseline, 24 Month Follow Up
The number of physical and/or sexual intimate partner violence encounters will be collected via the standard measure for Assessment of Intimate Partner Violence for the Global Program to Prevention Violence Against Women and Girls at baseline, month 12, and month 24.
Baseline, 24 Month Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Cari Clark, Sc.D., M.P.H., Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2016

Primary Completion (Actual)

August 14, 2018

Study Completion (Actual)

August 14, 2018

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00091115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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