- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442152
Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants
Phone Survey for Understanding the Impact of COVID-19 on Caregiving and Family Dynamics on Bandebereho Study Participants
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kigali, Rwanda
- Rwanda Men's Resource Centre (Rwamrec)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
See intervention description
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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.
Other Names:
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No Intervention: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gender division of caregiving/domestic tasks
Time Frame: ~5 years post intervention
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Question about how caregiving is distributed in the wake of Covid-19
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~5 years post intervention
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Couple communication
Time Frame: ~5 years post intervention
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Frequency of couple communication in the wake of Covid-19
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~5 years post intervention
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Couple conflict
Time Frame: ~5 years post intervention
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Frequency of couple quarreling in the wake of Covid-19
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~5 years post intervention
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Men's alcohol use
Time Frame: ~5 years post intervention
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Frequency of men's alcohol use in the wake of Covid-19
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~5 years post intervention
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Household economic situation
Time Frame: ~5 years post intervention
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Changes in household economic situation in the wake of Covid-19
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~5 years post intervention
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Stress and frustration
Time Frame: ~5 years post intervention
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Feelings of stress and frustration in the wake of Covid-19
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~5 years post intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kate E Doyle, MA, Promundo-US
- Principal Investigator: Ruti G Levtov, PhD, Promundo-US
- Principal Investigator: Felix Sayingoza, MD, MSc, Ministry of Health/Rwanda Biomedical Center
- Principal Investigator: Fidele Rutayisire, MA, Rwanda Men's Resource Center
- Principal Investigator: Shamsi Kazimbaya, MA, Promundo-US
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 265A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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