CClinicalTrials.gg
CompletedNCT04861870Updated Oct 29, 2021

Bandebereho 6 Year Follow up RCT in Rwanda

An interventional study of MenCare+/Bandebereho fathers'/couples' group education in Gender Relations, Violence and Child Development, sponsored by Promundo, United States. Completed at 1 site in Rwanda. Open to participants aged 21 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-29.

Sponsored by Promundo, United States · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,818
Allocation
Randomized
Ages
21 Years to 35 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Gender Relations
  • Violence
  • Child Development
  • Contraception
  • Prenatal Care
  • Partner Communication

Keywords

  • Gender
  • Violence
  • Early childhood development (ECD)
  • Caregiving
  • Parenting
  • MNCH
  • Reproductive health
03

In context

Lead sponsor

Promundo, United States is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria at baseline:

  • Participated in previous cycles of the same intervention
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,818 participants (actual)

Study arms

  • Experimental
    Intervention

    See intervention description

    Behavioral: MenCare+/Bandebereho fathers'/couples' group education

  • 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.

Interventions

  • BehavioralMenCare+/Bandebereho fathers'/couples' group education

    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.

    Also known as: Program P

06

What researchers measure

Primary outcomes

  1. Women's experiences of intimate partner violence (physical & sexual)

    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.

    Time frame: Experience of violence in past 12 months, measured 6 years post intervention

  2. Use of violence/harsh punishment against children

    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.

    Time frame: 6 years post intervention

  3. Observation-based child development measure

    Observation-based scores on the International Development and Early Learning Assessment (IDELA) for children ages 4-7

    Time frame: 6 years post intervention

  4. Child behavior assessment

    Parent-reported scores on Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 6 years post intervention

Secondary outcomes

  1. Family planning

    Self reported responses on current use of family planning methods, using Demographic and Health Survey (DHS) measure.

    Time frame: 6 years post intervention

  2. Antenatal care (ANC) service utilization

    Self reported responses on women's frequency of ANC visits during most recent pregnancy, using DHS measure (women only).

    Time frame: 6 years post intervention

  3. Antenatal care (ANC) accompaniment

    Self reported responses on men's frequency of accompaniment to ANC visits during most recent pregnancy, adapted from International Men and Gender Equality Survey.

    Time frame: 6 years post intervention

  4. Parenting behaviors with children

    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).

    Time frame: 6 years post intervention

  5. Parenting behaviors and adjustment

    Select items related to parenting behaviors and feelings adapted from the Parenting and Family Adjustment Scales (PAFAS).

    Time frame: 6 years post intervention

  6. Time spent/gender division of caregiving/domestic tasks and paid work

    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.

    Time frame: 6 years post intervention

Other outcomes

  1. Couple communication

    A composite capturing frequency of communication across multiple topics.

    Time frame: 6 years post intervention

  2. Gender-related attitudes

    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.

    Time frame: 6 years post intervention

  3. Decision-making in relationship

    Self-reported responses on who makes the decision in the relationship, adapted from the DHS.

    Time frame: 6 years post intervention

  4. Frequency of quarreling

    Self-reported response to one item capturing frequency of quarreling in the couple.

    Time frame: 6 years post intervention

  5. Relationship quality and conflict resolution

    Self-reported relationship quality items adapted from the relationship quality scale from the Decision Making in Low-Income Couples scale.

    Time frame: 6 years post intervention

  6. Relationship conflict resolution

    Self-reported items on couple communication and resolution in conflict adapted from the Couple Functionality Assessment.

    Time frame: 6 years post intervention

  7. Alcohol use

    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).

    Time frame: 6 years post intervention

  8. Depression/Mental health

    Self reported symptoms in past week, adapted from the Center for Epidemiologic Studies Depression Scale (CES-D) short form.

    Time frame: 6 years post intervention

  9. Reproductive coercion

    Women's self reported experience with reproductive coercion from their current partner in the past year, adapted from the Reproductive Autonomy coercion subscale.

    Time frame: Coercion in the past year, measured 6 years post intervention

07

Study locations

1 site
  • Rwanda Men's Resource Centre
    Kigali, Rwanda
08

References and documents

Publications

  • 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. PubMed 29617375 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04861870
Lead sponsor
Promundo, United States
Collaborators
Rwanda Men's Resource Centre
Responsible party
Sponsor
First posted
Apr 27, 2021
Start date
Jun 15, 2021
Primary completion
Sep 7, 2021
Completion
Sep 7, 2021
Last update
Oct 29, 2021

Study contacts

Kate E Doyle
principal investigator · Promundo-US
Ruti G Levtov
principal investigator · Prevention Collaborative
Fidele Rutayisire
principal investigator · Rwanda Men's Resource Centre
Shamsi Kazimbaya
principal investigator · Promundo-US
Felix Sayinzoga
principal investigator · Rwanda Biomedical Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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