Contraception Clinical Trial
Official title:
Bandebereho Randomized Control Trial: Six Year Follow-up to Assess the Impact of a Gender-transformative Intervention With Couples to Promote Men's Engagement in Maternal, Newborn and Child Health, Caregiving and Healthier Couple Relations
NCT number | NCT04861870 |
Other study ID # | RWN6YR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2021 |
Est. completion date | September 7, 2021 |
Verified date | October 2021 |
Source | Promundo, United States |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study seeks to conduct a six-year follow-up of the Bandebereho randomized control trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children. The Bandebereho program was implemented by the Rwanda Men's Resource Centre (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities between 2013 and 2015. A two-arm RCT collected three rounds of data from 1,199 couples (575 treatment; 624 control) starting in 2015-16: baseline (pre-intervention), 9 month follow-up, and 21-month follow-up. The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. This study will conduct surveys with men enrolled in the RCT and their female partners 6 years after the intervention, to assess its long-term impact on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development. In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.
Status | Completed |
Enrollment | 2818 |
Est. completion date | September 7, 2021 |
Est. primary completion date | September 7, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 35 Years |
Eligibility | Inclusion Criteria at baseline: - Men aged 21-35 years - Living with a partner - Expectant (or soon to be) father or father of young children under-5 - Living in an area with a group facilitator Exclusion Criteria at baseline: - Participated in previous cycles of the same intervention |
Country | Name | City | State |
---|---|---|---|
Rwanda | Rwanda Men's Resource Centre | Kigali |
Lead Sponsor | Collaborator |
---|---|
Promundo, United States | Rwanda Men's Resource Centre |
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 an — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Couple communication | A composite capturing frequency of communication across multiple topics. | 6 years post intervention | |
Other | Gender-related attitudes | A continuous scale variable, adapted from the validated Gender Equitable Men (GEM) scale; scores range from 1 to 5, with higher scores indicating more equitable attitudes. | 6 years post intervention | |
Other | Decision-making in relationship | Self-reported responses on who makes the decision in the relationship, adapted from the DHS. | 6 years post intervention | |
Other | Frequency of quarreling | Self-reported response to one item capturing frequency of quarreling in the couple. | 6 years post intervention | |
Other | Relationship quality and conflict resolution | Self-reported relationship quality items adapted from the relationship quality scale from the Decision Making in Low-Income Couples scale. | 6 years post intervention | |
Other | Relationship conflict resolution | Self-reported items on couple communication and resolution in conflict adapted from the Couple Functionality Assessment. | 6 years post intervention | |
Other | Alcohol use | Self reported alcohol use (men & women) and women's reports on partners' alcohol use (women) in past year, adapted from the Alcohol Use Disorders Identification Test (AUDIT). | 6 years post intervention | |
Other | Depression/Mental health | Self reported symptoms in past week, adapted from the Center for Epidemiologic Studies Depression Scale (CES-D) short form. | 6 years post intervention | |
Other | Reproductive coercion | Women's self reported experience with reproductive coercion from their current partner in the past year, adapted from the Reproductive Autonomy coercion subscale. | Coercion in the past year, measured 6 years post intervention | |
Primary | Women's experiences of intimate partner violence (physical & sexual) | A composite capturing self-reported exposure to a standard set of violent acts by a partner in past 12 months, adapted from World Health Organisation's multi-country study on violence against women. | Experience of violence in past 12 months, measured 6 years post intervention | |
Primary | Use of violence/harsh punishment against children | A composite capturing respondents' self reported use of various harsh discipline acts in the past month, adapted from the UNICEF Multiple Indicator Cluster Surveys (MICS) study. | 6 years post intervention | |
Primary | Observation-based child development measure | Observation-based scores on the International Development and Early Learning Assessment (IDELA) for children ages 4-7 | 6 years post intervention | |
Primary | Child behavior assessment | Parent-reported scores on Strengths and Difficulties Questionnaire (SDQ) | 6 years post intervention | |
Secondary | Family planning | Self reported responses on current use of family planning methods, using Demographic and Health Survey (DHS) measure. | 6 years post intervention | |
Secondary | Antenatal care (ANC) service utilization | Self reported responses on women's frequency of ANC visits during most recent pregnancy, using DHS measure (women only). | 6 years post intervention | |
Secondary | Antenatal care (ANC) accompaniment | Self reported responses on men's frequency of accompaniment to ANC visits during most recent pregnancy, adapted from International Men and Gender Equality Survey. | 6 years post intervention | |
Secondary | Parenting behaviors with children | Composite variable capturing behaviors with children in the past week (e.g. reading stories, playing, etc.) adapted from IDELA HOME and select items related to parenting behaviors adapted from the Parenting and Family Adjustment Scales (PAFAS). | 6 years post intervention | |
Secondary | Parenting behaviors and adjustment | Select items related to parenting behaviors and feelings adapted from the Parenting and Family Adjustment Scales (PAFAS). | 6 years post intervention | |
Secondary | Time spent/gender division of caregiving/domestic tasks and paid work | a) A composite measure of self-reported time spent on specific tasks in the past week; and b) self-reported distribution of tasks between partners. | 6 years post intervention |
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