- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04861870
Bandebereho 6 Year Follow up RCT in Rwanda
October 27, 2021 updated by: Promundo, United States
Bandebereho Randomized Control Trial: Six Year Follow-up to Assess the Impact of a Gender-transformative Intervention With Couples to Promote Men's Engagement in Maternal, Newborn and Child Health, Caregiving and Healthier Couple Relations
This study seeks to conduct a six-year follow-up of the Bandebereho randomized control trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children.
The Bandebereho program was implemented by the Rwanda Men's Resource Centre (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities between 2013 and 2015.
A two-arm RCT collected three rounds of data from 1,199 couples (575 treatment; 624 control) starting in 2015-16: baseline (pre-intervention), 9 month follow-up, and 21-month follow-up.
The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes.
This study will conduct surveys with men enrolled in the RCT and their female partners 6 years after the intervention, to assess its long-term impact on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development.
In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study seeks to conduct a six-year follow-up of the Bandebereho randomized controlled trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children.
The Bandebereho program being assessed was first implemented by the Rwanda Men's Resource Center (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities in Karongi, Musanze, Nyaruguru and Nyaruguru districts between 2013 and 2015.
A two-arm RCT was conducted with 1,199 couples (575 treatment; 624 control) in 2015-16.
Three rounds of data were collected: baseline (pre-intervention), 9 month follow-up (4 months post-intervention), and 21-month follow-up (16 months post-intervention).
The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes.
The proposed study will conduct surveys with men enrolled in the RCT and their female partners, to assess the longer-term impact of the intervention on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development.
In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.
Study Type
Interventional
Enrollment (Actual)
2818
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kigali, Rwanda
- Rwanda Men's Resource Centre
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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
21 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria at baseline:
- Men aged 21-35 years
- Living with a partner
- Expectant (or soon to be) father or father of young children under-5
- Living in an area with a group facilitator
Exclusion Criteria at baseline:
- Participated in previous cycles of the same intervention
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
See intervention description
|
MenCare+/Bandebereho was a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda.
A core component of the project is fathers'/couples' group education.
The target participants were first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities.
The MenCare+/Bandebereho fathers'/couples' group education engaged men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual.
Men's partners participate in 6-8 sessions.
The sessions focused on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
Other Names:
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NO_INTERVENTION: Control
Participants randomized into the control arm are surveyed at the same time points as intervention participants, but did not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Women's experiences of intimate partner violence (physical & sexual)
Time Frame: Experience of violence in past 12 months, measured 6 years post intervention
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A composite capturing self-reported exposure to a standard set of violent acts by a partner in past 12 months, adapted from World Health Organisation's multi-country study on violence against women.
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Experience of violence in past 12 months, measured 6 years post intervention
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Use of violence/harsh punishment against children
Time Frame: 6 years post intervention
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A composite capturing respondents' self reported use of various harsh discipline acts in the past month, adapted from the UNICEF Multiple Indicator Cluster Surveys (MICS) study.
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6 years post intervention
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Observation-based child development measure
Time Frame: 6 years post intervention
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Observation-based scores on the International Development and Early Learning Assessment (IDELA) for children ages 4-7
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6 years post intervention
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Child behavior assessment
Time Frame: 6 years post intervention
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Parent-reported scores on Strengths and Difficulties Questionnaire (SDQ)
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6 years post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family planning
Time Frame: 6 years post intervention
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Self reported responses on current use of family planning methods, using Demographic and Health Survey (DHS) measure.
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6 years post intervention
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Antenatal care (ANC) service utilization
Time Frame: 6 years post intervention
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Self reported responses on women's frequency of ANC visits during most recent pregnancy, using DHS measure (women only).
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6 years post intervention
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Antenatal care (ANC) accompaniment
Time Frame: 6 years post intervention
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Self reported responses on men's frequency of accompaniment to ANC visits during most recent pregnancy, adapted from International Men and Gender Equality Survey.
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6 years post intervention
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Parenting behaviors with children
Time Frame: 6 years post intervention
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Composite variable capturing behaviors with children in the past week (e.g.
reading stories, playing, etc.) adapted from IDELA HOME and select items related to parenting behaviors adapted from the Parenting and Family Adjustment Scales (PAFAS).
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6 years post intervention
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Parenting behaviors and adjustment
Time Frame: 6 years post intervention
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Select items related to parenting behaviors and feelings adapted from the Parenting and Family Adjustment Scales (PAFAS).
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6 years post intervention
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Time spent/gender division of caregiving/domestic tasks and paid work
Time Frame: 6 years post intervention
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a) A composite measure of self-reported time spent on specific tasks in the past week; and b) self-reported distribution of tasks between partners.
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6 years post intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Couple communication
Time Frame: 6 years post intervention
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A composite capturing frequency of communication across multiple topics.
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6 years post intervention
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Gender-related attitudes
Time Frame: 6 years post intervention
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A continuous scale variable, adapted from the validated Gender Equitable Men (GEM) scale; scores range from 1 to 5, with higher scores indicating more equitable attitudes.
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6 years post intervention
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Decision-making in relationship
Time Frame: 6 years post intervention
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Self-reported responses on who makes the decision in the relationship, adapted from the DHS.
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6 years post intervention
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Frequency of quarreling
Time Frame: 6 years post intervention
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Self-reported response to one item capturing frequency of quarreling in the couple.
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6 years post intervention
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Relationship quality and conflict resolution
Time Frame: 6 years post intervention
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Self-reported relationship quality items adapted from the relationship quality scale from the Decision Making in Low-Income Couples scale.
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6 years post intervention
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Relationship conflict resolution
Time Frame: 6 years post intervention
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Self-reported items on couple communication and resolution in conflict adapted from the Couple Functionality Assessment.
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6 years post intervention
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Alcohol use
Time Frame: 6 years post intervention
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Self reported alcohol use (men & women) and women's reports on partners' alcohol use (women) in past year, adapted from the Alcohol Use Disorders Identification Test (AUDIT).
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6 years post intervention
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Depression/Mental health
Time Frame: 6 years post intervention
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Self reported symptoms in past week, adapted from the Center for Epidemiologic Studies Depression Scale (CES-D) short form.
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6 years post intervention
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Reproductive coercion
Time Frame: Coercion in the past year, measured 6 years post intervention
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Women's self reported experience with reproductive coercion from their current partner in the past year, adapted from the Reproductive Autonomy coercion subscale.
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Coercion in the past year, measured 6 years post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate E Doyle, Promundo-US
- Principal Investigator: Ruti G Levtov, Prevention Collaborative
- Principal Investigator: Fidele Rutayisire, Rwanda Men's Resource Centre
- Principal Investigator: Shamsi Kazimbaya, Promundo-US
- Principal Investigator: Felix Sayinzoga, Rwanda Biomedical Centre
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.
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)
June 15, 2021
Primary Completion (ACTUAL)
September 7, 2021
Study Completion (ACTUAL)
September 7, 2021
Study Registration Dates
First Submitted
April 19, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (ACTUAL)
April 27, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 29, 2021
Last Update Submitted That Met QC Criteria
October 27, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RWN6YR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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