Clinical trial NCT04442152: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gender Relations
Partner Communication
Division of Carework
Couple Conflict
Stress
Keywords: gender, caregiving, Covid-19, couple relations
Lead sponsor: Promundo, United States
Sponsor class: OTHER
Collaborators: name: Rwanda Men's Resource Center (Rwamrec)
name: Ministry of Health/Rwanda Biomedical Center
First posted: 2020-06-22
Enrollment: 998
Sex: ALL
Minimum age (years): 26
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Gender division of caregiving/domestic tasks
timeFrame: ~5 years post intervention
measure: Couple communication
timeFrame: ~5 years post intervention
measure: Couple conflict
timeFrame: ~5 years post intervention
measure: Men's alcohol use
timeFrame: ~5 years post intervention
measure: Household economic situation
timeFrame: ~5 years post intervention
measure: Stress and frustration
timeFrame: ~5 years post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Men's Resource Centre (Rwamrec)
Study officials:
affiliation: Promundo-US
name: Kate E Doyle, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Promundo-US
name: Ruti G Levtov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health/Rwanda Biomedical Center
name: Felix Sayingoza, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Men's Resource Center
name: Fidele Rutayisire, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Promundo-US
name: Shamsi Kazimbaya, MA
role: PRINCIPAL_INVESTIGATOR
References:
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.