- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694627
Bandebereho Father Groups Randomized Control Trial in Rwanda
April 3, 2017 updated by: Promundo, United States
Bandebereho Father Groups: a Randomized Control Trial to Assess the Impact of Maternal, Newborn and Child Health Group Education for New and Expecting Fathers
This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group education intervention on men's attitudes towards, and participation in, sexual and reproductive health, maternal, newborn and child health, and equitable and non-violent relationships with their children and partners.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group education intervention on men's attitudes towards, and participation in, sexual and reproductive health, maternal, newborn and child health, and equitable and non-violent relationships with their children and partners.
The MenCare+/ Bandebereho program is a multi-component comprehensive intervention being 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 Rwamagana districts.
The proposed study will evaluate one component of the program, a 15-session group education intervention targeting young fathers and mothers.
The impact of the fathers' group education will be assessed through a randomized control trial design with an intervention arm of men and women participating in the father groups and a control arm of men and women who do not participate in the intervention.
The study will collect quantitative and qualitative data over a period of approximately three years.
Study Type
Interventional
Enrollment (Anticipated)
2400
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
21 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
See intervention description
|
MenCare+/Bandebereho is 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 are 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 engages 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 focus on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
Other Names:
|
|
No Intervention: Control
Participants randomized into the control arm are surveyed at the same time points as intervention participants, but do not receive any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gender division of caregiving/domestic tasks (from questionnaire: a) composite capturing frequency of the respondent doing household or caregiving tasks; b) composite capturing how tasks are shared between partners).
Time Frame: 4 months post intervention
|
4 months post intervention
|
|
Men's participation in family planning and maternal, newborn and child health (from questionnaire: a) men's presence at antenatal care visits; b) women's reports of receiving partner support during pregnancy; c) use of family planning).
Time Frame: 4 months post intervention
|
4 months post intervention
|
|
Gender-related attitudes (from questionnaire: a continuous scale variable, adapted from the validated Gender Equitable Men (GEM) scale).
Time Frame: 4 months post intervention
|
4 months post intervention
|
|
Women's experiences of intimate partner violence (from: questionnaire: a composite capturing exposure to a standard set of violent acts by a partner).
Time Frame: 4 months post intervention
|
4 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Use of violence/harsh punishment against children (from questionnaire: a composite capturing respondents' use of various harsh discipline acts in the past month, adapted from the UNICEF MICS study).
Time Frame: 4 months post intervention
|
4 months post intervention
|
|
Relationship quality measured (from questionnaire: a) frequency of quarreling and b) quality scale adapted from the Decision Making in Low-Income Couples).
Time Frame: 4 months post intervention
|
4 months post intervention
|
|
Couple communication (from questionnaire: a composite capturing frequency of communication across multiple topics).
Time Frame: 4 months post intervention
|
4 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate E Doyle, MA, Promundo-US
- Principal Investigator: Ruti G Levtov, PhD, Promundo-US
- Principal Investigator: Gary Barker, PhD, Promundo-US
- Principal Investigator: Shamsi Kazimbaya, MA, formerly at Rwanda Men's Resource Center, now at Jhpiego
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
- Levtov RG, Doyle K, Bingenheimer JB, Lahiri S, Kazimbaya S, Karamage E, Sayinzoga F, Mutoni M, Rubayita CH, Barker G. Improved Relationship Quality, Equitable Gender Attitudes, and Reduced Alcohol Abuse as Key Mechanisms to Reduce Intimate Partner Violence in the Bandebereho Couples' Randomized Trial in Rwanda. Prev Sci. 2022 Nov;23(8):1495-1506. doi: 10.1007/s11121-022-01445-6. Epub 2022 Oct 11.
- Doyle K, Levtov RG, Barker G, Bastian GG, Bingenheimer JB, Kazimbaya S, Nzabonimpa A, Pulerwitz J, Sayinzoga F, Sharma V, Shattuck D. Gender-transformative Bandebereho couples' intervention to promote male engagement in reproductive and maternal health and violence prevention in Rwanda: Findings from a randomized controlled trial. PLoS One. 2018 Apr 4;13(4):e0192756. doi: 10.1371/journal.pone.0192756. eCollection 2018.
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)
February 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
February 19, 2016
First Submitted That Met QC Criteria
February 23, 2016
First Posted (Estimate)
February 29, 2016
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 137D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Contraception
-
Virginia Commonwealth UniversityCompletedPregnancy Related | Contraception | Contraception Behavior | Contraception Use
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Janssen Pharmaceutica N.V., BelgiumCompleted
-
Medical University of South CarolinaSociety of Family PlanningCompletedContraception | Contraception BehaviorUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedFemale Contraception | ContraceptionUnited States, Israel
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Montefiore Medical CenterSociety of Family PlanningCompletedContraception | Breastfeeding | Postpartum ContraceptionUnited States
Clinical Trials on MenCare+/Bandebereho fathers'/couples' group education
-
Promundo, United StatesRwanda Men's Resource CentreCompletedContraception | Child Development | Violence | Gender Relations | Prenatal Care | Partner CommunicationRwanda
-
Promundo, United StatesRwanda Men's Resource Center (Rwamrec); Ministry of Health/Rwanda Biomedical...CompletedStress | Gender Relations | Partner Communication | Division of Carework | Couple ConflictRwanda
-
MetroHealth Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; MetroHealth...Not yet recruitingObstructive Sleep Apnea (OSA)United States
-
VA Office of Research and DevelopmentCompletedDepression | Posttraumatic Stress Disorders | Mild Traumatic Brain InjuryUnited States