Bandebereho 6 Year Follow up RCT in Rwanda

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861870
• Other study ID #: RWN6YR
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: October 2021
• Source: Promundo, United States
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study seeks to conduct a six-year follow-up of the Bandebereho randomized controlled 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 being assessed was first 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 Nyaruguru districts between 2013 and 2015. A two-arm RCT was conducted with 1,199 couples (575 treatment; 624 control) in 2015-16. Three rounds of data were collected: baseline (pre-intervention), 9 month follow-up (4 months post-intervention), and 21-month follow-up (16 months post-intervention). The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. The proposed study will conduct surveys with men enrolled in the RCT and their female partners, to assess the longer-term impact of the intervention 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Child Development
• Contraception
• Gender Relations
• Partner Communication
• Prenatal Care
• Violence

Intervention

Behavioral:
• MenCare+/Bandebereho fathers'/couples' group education
MenCare+/Bandebereho was 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 engaged 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 focused on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.

Locations

Country	Name	City	State
Rwanda	Rwanda Men's Resource Centre	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
Promundo, United States	Rwanda Men's Resource Centre

Country where clinical trial is conducted

Rwanda, 

References & Publications (1)

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

Outcome

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