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Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants

Primary Purpose

Gender Relations, Partner Communication, Division of Carework

Status
Completed
Phase
Not Applicable
Locations
Rwanda
Study Type
Interventional
Intervention
MenCare+/Bandebereho fathers'/couples' group education
Sponsored by
Promundo, United States
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gender Relations focused on measuring gender, caregiving, Covid-19, couple relations

Eligibility Criteria

26 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rwanda Men's Resource Centre (Rwamrec)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

See intervention description

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.

Outcomes

Primary Outcome Measures

Gender division of caregiving/domestic tasks
Question about how caregiving is distributed in the wake of Covid-19
Couple communication
Frequency of couple communication in the wake of Covid-19
Couple conflict
Frequency of couple quarreling in the wake of Covid-19
Men's alcohol use
Frequency of men's alcohol use in the wake of Covid-19
Household economic situation
Changes in household economic situation in the wake of Covid-19
Stress and frustration
Feelings of stress and frustration in the wake of Covid-19

Secondary Outcome Measures

Full Information

First Posted
June 19, 2020
Last Updated
March 11, 2022
Sponsor
Promundo, United States
Collaborators
Rwanda Men's Resource Center (Rwamrec), Ministry of Health/Rwanda Biomedical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04442152
Brief Title
Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants
Official Title
Phone Survey for Understanding the Impact of COVID-19 on Caregiving and Family Dynamics on Bandebereho Study Participants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
September 4, 2020 (Actual)
Study Completion Date
September 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promundo, United States
Collaborators
Rwanda Men's Resource Center (Rwamrec), Ministry of Health/Rwanda Biomedical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Relations, Partner Communication, Division of Carework, Couple Conflict, Stress
Keywords
gender, caregiving, Covid-19, couple relations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
998 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
See intervention description
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MenCare+/Bandebereho fathers'/couples' group education
Other Intervention Name(s)
Program P
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gender division of caregiving/domestic tasks
Description
Question about how caregiving is distributed in the wake of Covid-19
Time Frame
~5 years post intervention
Title
Couple communication
Description
Frequency of couple communication in the wake of Covid-19
Time Frame
~5 years post intervention
Title
Couple conflict
Description
Frequency of couple quarreling in the wake of Covid-19
Time Frame
~5 years post intervention
Title
Men's alcohol use
Description
Frequency of men's alcohol use in the wake of Covid-19
Time Frame
~5 years post intervention
Title
Household economic situation
Description
Changes in household economic situation in the wake of Covid-19
Time Frame
~5 years post intervention
Title
Stress and frustration
Description
Feelings of stress and frustration in the wake of Covid-19
Time Frame
~5 years post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate E Doyle, MA
Organizational Affiliation
Promundo-US
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruti G Levtov, PhD
Organizational Affiliation
Promundo-US
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Sayingoza, MD, MSc
Organizational Affiliation
Ministry of Health/Rwanda Biomedical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fidele Rutayisire, MA
Organizational Affiliation
Rwanda Men's Resource Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shamsi Kazimbaya, MA
Organizational Affiliation
Promundo-US
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rwanda Men's Resource Centre (Rwamrec)
City
Kigali
Country
Rwanda

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29617375
Citation
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.
Results Reference
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Impact of COVID-19 on Family Dynamics on Bandebereho Study Participants

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