Stress Clinical Trial
Official title:
Phone Survey for Understanding the Impact of COVID-19 on Caregiving and Family Dynamics on Bandebereho Study Participants
NCT number | NCT04442152 |
Other study ID # | 265A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 13, 2020 |
Est. completion date | September 4, 2020 |
Verified date | March 2022 |
Source | Promundo, United States |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 998 |
Est. completion date | September 4, 2020 |
Est. primary completion date | September 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 26 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Rwanda | Rwanda Men's Resource Centre (Rwamrec) | Kigali |
Lead Sponsor | Collaborator |
---|---|
Promundo, United States | Ministry of Health/Rwanda Biomedical Center, Rwanda Men's Resource Center (Rwamrec) |
Rwanda,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gender division of caregiving/domestic tasks | Question about how caregiving is distributed in the wake of Covid-19 | ~5 years post intervention | |
Primary | Couple communication | Frequency of couple communication in the wake of Covid-19 | ~5 years post intervention | |
Primary | Couple conflict | Frequency of couple quarreling in the wake of Covid-19 | ~5 years post intervention | |
Primary | Men's alcohol use | Frequency of men's alcohol use in the wake of Covid-19 | ~5 years post intervention | |
Primary | Household economic situation | Changes in household economic situation in the wake of Covid-19 | ~5 years post intervention | |
Primary | Stress and frustration | Feelings of stress and frustration in the wake of Covid-19 | ~5 years post intervention |
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