Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-20 @ 6:23 PM
Study NCT ID:
NCT02942433
Status:
COMPLETED
Last Update Posted:
2018-12-14
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intimate Partner Violence Prevention in Nepal
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: