Gender RelationsNCT04442152
Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants
A study testing MenCare+/Bandebereho fathers'/couples' group education in people with Gender Relations and Partner Communication, run by Promundo, United States at 1 site in Rwanda.
Trial summary
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not… Read more about this study
- Who is it for?
- Ages 26 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Relations, Partner Communication, Division of Carework
- 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
- 998 participants
- Where
- 1 siteRwanda
- Study dates
- 13 Aug 2020to 4 Sep 2020
- 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 26 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Original inclusion criteria in the original RCT study included, for men: being between the ages of 21-35, expecting a child or having one or more children under the age of five, living in a stable partnership, and residing in the study site. For women, the criteria were simply being the partner of one of the men selected for the study.
Inclusion criteria for this study include previous participation in the RCT, and that the respondent indicated they or their partner owned a telephone/phone in the 21-month follow up that was conducted in November/December 2016. Based on data from the 21-month followup, approximately 80% of respondents reported a cell phone owned by them or their partner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phone Survey for Understanding the Impact of COVID-19 on Caregiving and Family Dynamics on Bandebereho Study Participants
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.
Read the detailed description
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. It will contribute to documenting whether and how this disruptive moment might be changing or influencing relationship dynamics, conflict, and the distribution of care-work. We will build on an existing randomized controlled trial of the Bandebereho fathers/couples intervention, which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress. The Bandebereho fathers/couples intervention was 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 from 2013-2015. Results from a randomized controlled study of Bandebereho, a gender transformative intervention for expectant couples originally implemented in 4 districts in 2015, showed positive results across multiple outcomes after 21 months.
- Being tested
- MenCare+/Bandebereho fathers'/couples' group education
- Keywords
- gender, caregiving, Covid-19, couple relations
- Medical subject headings
- Coitus, COVID-19
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 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 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 who were randomized into the control arm were and will be surveyed at the same time point 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.
Gender division of caregiving/domestic tasks
Question about how caregiving is distributed in the wake of Covid-19
Measured: ~5 years post intervention
Couple communication
Frequency of couple communication in the wake of Covid-19
Measured: ~5 years post intervention
Couple conflict
Frequency of couple quarreling in the wake of Covid-19
Measured: ~5 years post intervention
Men's alcohol use
Frequency of men's alcohol use in the wake of Covid-19
Measured: ~5 years post intervention
Household economic situation
Changes in household economic situation in the wake of Covid-19
Measured: ~5 years post intervention
Stress and frustration
Feelings of stress and frustration in the wake of Covid-19
Measured: ~5 years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start13 Aug 2020
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promundo, United States
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Men's Resource Center (Rwamrec), Ministry of Health/Rwanda Biomedical Center
- Responsible party
- Sponsor
- Investigators
- Kate E Doyle, MA, Principal investigator, Promundo-USRuti G Levtov, PhD, Principal investigator, Promundo-USFelix Sayingoza, MD, MSc, Principal investigator, Ministry of Health/Rwanda Biomedical CenterFidele Rutayisire, MA, Principal investigator, Rwanda Men's Resource CenterShamsi Kazimbaya, MA, Principal investigator, Promundo-US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442152
- Sponsor's protocol ID
- 265A
- Status last verified
- Mar 2022
- First submitted
- 19 Jun 2020
- Last updated
- 15 Mar 2022
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone Survey for Understanding the Impact of COVID-19 on Caregiving and Family Dynamics on Bandebereho Study Participants
- ClinicalTrials.gov ID
- NCT04442152
- Acronym / sponsor ID
- 265A
- Keywords
- gender, caregiving, Covid-19, couple relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Promundo, United StatesUniversity, hospital or other
- Collaborators
- Rwanda Men's Resource Center (Rwamrec), Ministry of Health/Rwanda Biomedical Center
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- 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 proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.
Detailed description
This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. It will contribute to documenting whether and how this disruptive moment might be changing or influencing relationship dynamics, conflict, and the distribution of care-work. We will build on an existing randomized controlled trial of the Bandebereho fathers/couples intervention, which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress. The Bandebereho fathers/couples intervention was 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 from 2013-2015. Results from a randomized controlled study of Bandebereho, a gender transformative intervention for expectant couples originally implemented in 4 districts in 2015, showed positive results across multiple outcomes after 21 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MenCare+/Bandebereho fathers'/couples' group educationSee intervention description |
| Control | No intervention | –Participants who were randomized into the control arm were and will be surveyed at the same time point as intervention participants, but did not receive any intervention. |
Who may qualify
- Ages
- 26 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 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 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
Time frame: ~5 years post intervention
Question about how caregiving is distributed in the wake of Covid-19
Couple communication
Time frame: ~5 years post intervention
Frequency of couple communication in the wake of Covid-19
Couple conflict
Time frame: ~5 years post intervention
Frequency of couple quarreling in the wake of Covid-19
Men's alcohol use
Time frame: ~5 years post intervention
Frequency of men's alcohol use in the wake of Covid-19
Household economic situation
Time frame: ~5 years post intervention
Changes in household economic situation in the wake of Covid-19
Stress and frustration
Time frame: ~5 years post intervention
Feelings of stress and frustration in the wake of Covid-19
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 15 Mar 2022.
- Background: 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
Felix Sayingoza, MD, MSc principal investigator
Ministry of Health/Rwanda Biomedical Center
1 site in 1 country: see every site and its status.
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 Partner Communication, 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?
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 15 Mar 2022. 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?
Gender division of caregiving/domestic tasks (time frame: ~5 years post intervention). The study lists 6 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 NCT04442152, which also lists 1 linked publication.
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 15 Mar 2022.