Intimate Partner ViolenceNCT02942433
Intimate Partner Violence Prevention in Nepal
A study testing Behavior Change Communication, Community Mobilization and Advocacy in people with Intimate Partner Violence, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Behavior Change Communication, Community Mobilization and Advocacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,677 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2016to 14 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Intimate Partner Violence
- Being tested
- Behavior Change Communication, Community Mobilization, Advocacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Change CommunicationBehavioural
9-month weekly episode behavior change radio drama with interactive voice response (IVR)/short message service (SMS) listener engagement
Community MobilizationBehavioural
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.
AdvocacyBehavioural
Training and 6-month follow up of religious/community leaders and religious leaders support community mobilization activity of local listening and discussion group (LGD).
| Study group | Role | What they receive |
|---|---|---|
| Radio Program | Experimental | 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. Receives: Behavioral: Behavior Change Communication; Behavioral: Community Mobilization; Behavioral: Advocacy |
| Control | Other | 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. Receives: Behavioral: Behavior Change Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prevalence of Physical and/or Sexual Intimate Partner Violence Encounters
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.
Measured: Baseline, 24 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start12 Mar 2016
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cari Clark, Emory University
- Investigators
- Cari Clark, Sc.D., M.P.H., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942433
- Sponsor's protocol ID
- IRB00091115
- Status last verified
- Dec 2018
- First submitted
- 13 Oct 2016
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Clark CJ, Batayeh B, Shrestha PN, Morrow G, Shrestha B, Ferguson G. Diffusion in social norms change about violence against women: A longitudinal analysis of intervention data from a cluster randomised trial. Glob Public Health. 2021 Oct;16(10):1618-1630. doi: 10.1080/17441692.2020.1828984. Epub 2020 Oct 6.
PubMed 33021877Clark CJ, Shrestha B, Ferguson G, Shrestha PN, Calvert C, Gupta J, Batayeh B, Bergenfeld I, Oakes JM. Impact of the Change Starts at Home Trial on Women's experience of intimate partner violence in Nepal. SSM Popul Health. 2019 Dec 13;10:100530. doi: 10.1016/j.ssmph.2019.100530. eCollection 2020 Apr.
PubMed 31890850Cardoso LF, Clark CJ, Rivers K, Ferguson G, Shrestha B, Gupta J. Menstrual restriction prevalence and association with intimate partner violence among Nepali women. BMJ Sex Reprod Health. 2018 Sep 28;45(1):38-43. doi: 10.1136/bmjsrh-2017-101908. Online ahead of print.
PubMed 30266716Clark CJ, Spencer RA, Shrestha B, Ferguson G, Oakes JM, Gupta J. Evaluating a multicomponent social behaviour change communication strategy to reduce intimate partner violence among married couples: study protocol for a cluster randomized trial in Nepal. BMC Public Health. 2017 Jan 13;17(1):75. doi: 10.1186/s12889-016-3909-9.
PubMed 28086857
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02942433
- Acronym / sponsor ID
- IRB00091115
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,677 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 12 Mar 2016 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio Program | Experimental | Behavioral: Behavior Change Communication, Behavioral: Community Mobilization, Behavioral: AdvocacyMarried 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. |
| Control | Other | Behavioral: Behavior Change CommunicationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior Change Communication9-month weekly episode behavior change radio drama with interactive voice response (IVR)/short message service (SMS) listener engagement | Behavioural | Control, Radio Program |
| Community MobilizationListening 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. | Behavioural | Radio Program |
| AdvocacyTraining and 6-month follow up of religious/community leaders and religious leaders support community mobilization activity of local listening and discussion group (LGD). | Behavioural | Radio Program |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 33021877Clark CJ, Batayeh B, Shrestha PN, Morrow G, Shrestha B, Ferguson G. Diffusion in social norms change about violence against women: A longitudinal analysis of intervention data from a cluster randomised trial. Glob Public Health. 2021 Oct;16(10):1618-1630. doi: 10.1080/17441692.2020.1828984. Epub 2020 Oct 6.
- Derived from this study: PubMed 31890850Clark CJ, Shrestha B, Ferguson G, Shrestha PN, Calvert C, Gupta J, Batayeh B, Bergenfeld I, Oakes JM. Impact of the Change Starts at Home Trial on Women's experience of intimate partner violence in Nepal. SSM Popul Health. 2019 Dec 13;10:100530. doi: 10.1016/j.ssmph.2019.100530. eCollection 2020 Apr.
- Derived from this study: PubMed 30266716Cardoso LF, Clark CJ, Rivers K, Ferguson G, Shrestha B, Gupta J. Menstrual restriction prevalence and association with intimate partner violence among Nepali women. BMJ Sex Reprod Health. 2018 Sep 28;45(1):38-43. doi: 10.1136/bmjsrh-2017-101908. Online ahead of print.
- Derived from this study: PubMed 28086857Clark CJ, Spencer RA, Shrestha B, Ferguson G, Oakes JM, Gupta J. Evaluating a multicomponent social behaviour change communication strategy to reduce intimate partner violence among married couples: study protocol for a cluster randomized trial in Nepal. BMC Public Health. 2017 Jan 13;17(1):75. doi: 10.1186/s12889-016-3909-9.
Related trials for Intimate Partner Violence
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
Recruiting
Multifaceted Intervention to Restore Resilience and Overcome Risk
Military Sexual Trauma, Intimate Partner Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cari Clark, Sc.D., M.P.H. principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Change Communication, Community Mobilization and Advocacy in people with Intimate Partner Violence, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prevalence of Physical and/or Sexual Intimate Partner Violence Encounters (time frame: Baseline, 24 Month Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942433, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.