Gender RelationsNCT02694627
Bandebereho Father Groups Randomized Control Trial in Rwanda
A study testing MenCare+/Bandebereho fathers'/couples' group education in people with Gender Relations and Prenatal Care, run by Promundo, United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Relations, Prenatal Care, Partner Communication
- What is being tested?
- MenCare+/Bandebereho fathers'/couples' group education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2017
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Participated in previous cycles of the same intervention
About this study
Official title: 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.
Read the 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.
- Conditions
- Gender Relations, Prenatal Care, Partner Communication, Contraception, Violence
- Being tested
- MenCare+/Bandebereho fathers'/couples' group education
- Keywords
- gender, caregiving, MNCH, violence, sexual and reproductive health, parenting
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenCare+/Bandebereho fathers'/couples' group educationBehavioural
Also called Program P
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | See intervention description Receives: Behavioral: MenCare+/Bandebereho fathers'/couples' group education |
| Control | No intervention | Participants randomized into the control arm are surveyed at the same time points as intervention participants, but do not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 4 months post intervention
Gender-related attitudes (from questionnaire: a continuous scale variable, adapted from the validated Gender Equitable Men (GEM) scale).
Measured: 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).
Measured: 4 months post intervention
Secondary outcomes (3)
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).
Measured: 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).
Measured: 4 months post intervention
Couple communication (from questionnaire: a composite capturing frequency of communication across multiple topics).
Measured: 4 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gender RelationsStudies of the same condition, open and under way.
- 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
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Promundo, United States
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Men's Resource Center (Rwamrec)
- Responsible party
- Sponsor
- Investigators
- Kate E Doyle, MA, Principal investigator, Promundo-USRuti G Levtov, PhD, Principal investigator, Promundo-USGary Barker, PhD, Principal investigator, Promundo-USShamsi Kazimbaya, MA, Principal investigator, formerly at Rwanda Men's Resource Center, now at Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694627
- Sponsor's protocol ID
- 137D
- Status last verified
- Apr 2017
- First submitted
- 19 Feb 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 36219325Doyle 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.
PubMed 29617375
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bandebereho Father Groups: a Randomized Control Trial to Assess the Impact of Maternal, Newborn and Child Health Group Education for New and Expecting Fathers
- ClinicalTrials.gov ID
- NCT02694627
- Acronym / sponsor ID
- 137D
- Conditions
- Gender Relations, Prenatal Care, Partner Communication, Contraception, Violence
- Keywords
- gender, caregiving, MNCH, violence, sexual and reproductive health, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Promundo, United StatesUniversity, hospital or other
- Collaborators
- Rwanda Men's Resource Center (Rwamrec)
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Feb 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MenCare+/Bandebereho fathers'/couples' group educationSee intervention description |
| Control | No intervention | –Participants randomized into the control arm are surveyed at the same time points as intervention participants, but do not receive any intervention. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participated in previous cycles of the same intervention
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 |
|---|---|---|
| MenCare+/Bandebereho fathers'/couples' group educationAlso: Program PMenCare+/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. | Behavioural | Intervention |
Primary outcome
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
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
Gender-related attitudes (from questionnaire: a continuous scale variable, adapted from the validated Gender Equitable Men (GEM) scale).
Time frame: 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
3 secondary outcomes
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
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
Couple communication (from questionnaire: a composite capturing frequency of communication across multiple topics).
Time frame: 4 months post intervention
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 4 Apr 2017.
- Derived from this study: PubMed 36219325Levtov 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.
- Derived from this study: PubMed 29617375Doyle 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.
- Individual participant dataSharing planned: No
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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.
Kate E Doyle, MA principal investigator
Promundo-US
Ruti G Levtov, PhD principal investigator
Promundo-US
Gary Barker, PhD principal investigator
Promundo-US
Questions about this trial
What is this clinical trial studying?
A study testing MenCare+/Bandebereho fathers'/couples' group education in people with Gender Relations and Prenatal Care, run by Promundo, United States.
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 4 inclusion and 1 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 4 Apr 2017. 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?
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). The study lists 4 primary outcomes in all. 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 NCT02694627, which also lists 2 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 4 Apr 2017.