AzTrials
AzTrials

Gender RelationsNCT04861870

Bandebereho 6 Year Follow up RCT in Rwanda

A study testing MenCare+/Bandebereho fathers'/couples' group education in people with Gender Relations and Violence, run by Promundo, United States at 1 site in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. 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, Violence, Child Development
What is being tested?
MenCare+/Bandebereho fathers'/couples' group education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,818 participants
Where
1 siteRwanda
Study dates
15 Jun 2021to 7 Sep 2021
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

Trial locations and contacts

1 site in 1 country.

Rwanda1 site

  • Rwanda Men's Resource Centre

    Kigali

Other trials in Rwanda

About this study

Official title: 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.

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.

Being tested
MenCare+/Bandebereho fathers'/couples' group education
Keywords
Gender, Violence, Early childhood development (ECD), Caregiving, Parenting, MNCH, Reproductive health
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 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.

Study groups in NCT04861870
Study groupRoleWhat they receive
InterventionExperimentalSee intervention description
Receives: Behavioral: MenCare+/Bandebereho fathers'/couples' group education
ControlNo interventionParticipants randomized into the control arm are surveyed at the same time points as intervention participants, but did not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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

    Measured: 6 years post intervention

  4. Child behavior assessment

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

    Measured: 6 years post intervention

Secondary outcomes (6)

  1. Family planning

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

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 6 years post intervention

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

    1. A composite measure of self-reported time spent on specific tasks in the past week; and b) self-reported distribution of tasks between partners.

    Measured: 6 years post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start15 Jun 2021
  3. Primary completion7 Sep 2021
  4. Study completion7 Sep 2021

Resources

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
2,818 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04861870
Sponsor's protocol ID
RWN6YR
Status last verified
Oct 2021
First submitted
19 Apr 2021
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Doyle K, Levtov RG, Karamage E, Rakshit D, Kazimbaya S, Sayinzoga F, Sibomana H, Ngayaboshya S, Rutayisire F, Barker G. Long-term impacts of the Bandebereho programme on violence against women and children, maternal health-seeking, and couple relations in Rwanda: a six-year follow-up of a randomised controlled trial. EClinicalMedicine. 2023 Sep 26;64:102233. doi: 10.1016/j.eclinm.2023.102233. eCollection 2023 Oct.

    PubMed 37781160

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 Violence, run by Promundo, United States at 1 site in Rwanda.

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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Women's experiences of intimate partner violence (physical & sexual) (time frame: Experience of violence in past 12 months, measured 6 years 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 NCT04861870, 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 29 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in