Father-Inclusive Parenting Intervention in Mwanza, Tanzania

NCT ID: NCT07025447

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2026-01-31

Brief Summary

This cluster-randomized controlled trial aims to evaluate the impact of a couples-based parenting program, "Familia Bora," on mothers' and fathers' parenting, couples' relationships, gender, and early child development in the Mwanza Region, Tanzania. Additionally, this study aims to assess the program's implementation and identify factors influencing its quality and effectiveness.

Trained community health workers will deliver the program by facilitating weekly peer group sessions in their villages. Twelve couples with a child under two years old will be enrolled in each village. The program will cover various topics, including responsive caregiving, positive discipline, stress management, healthy couples' communication, nutrition, and gender.

Detailed Description

An estimated 43% of children under five in low- and middle-income countries are at risk of not achieving their developmental potential, with the burden highest in sub-Saharan Africa. While there is robust evidence on the effectiveness of parenting interventions for improving nurturing care and early childhood development (ECD), the vast majority of existing programs have targeted mothers exclusively. Fathers are often excluded from parenting programs, even though evidence highlights their vital contributions to child and family wellbeing.

This cluster-randomized controlled trial will evaluate the impacts and implementation quality of a newly developed, culturally-responsive, gender-transformative, and father-inclusive parenting intervention ("Familia Bora"). The study will be implemented in 33 villages across Misungwi and Sengerema districts in Mwanza Region, Tanzania. Half of the villages will be randomly assigned to the intervention (17 villages) versus control group (16 villages) with stratification by district. The program will train community health workers (CHWs) to deliver the program to groups of 12 randomly selected couples per village.

Familia Bora primarily involves group sessions covering various topics, including responsive parenting, positive discipline, couples' communication, stress management, and gender roles in family caregiving. These group sessions will be held at a convenient community location on a weekly basis for approximately five months.

In total, the trial will enroll 396 couples with young children (i.e., 396 men and 396 female partners). Quantitative surveys will be conducted with fathers and mothers at baseline and endline to assess outcomes, including maternal and paternal parenting practices and attitudes, gender attitudes, relationship dynamics, and early childhood development. Quantitative data will be collected from CHWs at baseline and endline to assess program-related changes in their knowledge, attitudes, and skills. In addition to the quantitative evaluation, qualitative methods will be used to evaluate implementation processes and participant perspectives through midline and endline in-depth interviews with a subsample of caregivers and CHWs, community leaders, and other relevant stakeholders across the intervention villages.

Conditions

Parents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Familia Bora

Participants will be offered a parenting group program available in their community, with weekly scheduled sessions for approximately 5 months.

Group Type: EXPERIMENTAL

Familia Bora

Intervention Type: BEHAVIORAL

Familia Bora is a couples-based group parenting program that takes place in a preferred location within the community among participants. Twelve couples will be enrolled in each village and form one parenting group. CHWs will be trained to deliver the intervention.

The program will involve 17 group sessions. Each session is expected to last 1.5 hours and will be delivered weekly for approximately 5 months. Each session will focus on various topics, including responsive caregiving, positive discipline, managing emotions and stress management, child nutrition, couples' communication, non-violent conflict resolution strategies in relationships, gender equity, and early child care and education. In addition to the weekly group parenting sessions, CHWs will be encouraged to conduct home visits to engage couples who miss sessions, reinforce key messages, and provide extra support for caregivers and children as needed.

Control Group

Participants will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Familia Bora

Familia Bora is a couples-based group parenting program that takes place in a preferred location within the community among participants. Twelve couples will be enrolled in each village and form one parenting group. CHWs will be trained to deliver the intervention.

The program will involve 17 group sessions. Each session is expected to last 1.5 hours and will be delivered weekly for approximately 5 months. Each session will focus on various topics, including responsive caregiving, positive discipline, managing emotions and stress management, child nutrition, couples' communication, non-violent conflict resolution strategies in relationships, gender equity, and early child care and education. In addition to the weekly group parenting sessions, CHWs will be encouraged to conduct home visits to engage couples who miss sessions, reinforce key messages, and provide extra support for caregivers and children as needed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Each individual is an adult aged 18-65 years
• Each individual is the primary female or male caregiver of a child younger than 2 years of age
• The two individuals are currently in a marital or partnered relationship with each other
• Both individuals have lived in the same household as each other and the child during the past month, and
• Both individuals provide written informed consent to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanzania Home Economics Organization

UNKNOWN

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Jeong

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Jeong, ScD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Communities in Mwanza,Tanzania

Mwanza, , Tanzania

Countries

United States; Tanzania

Other Identifiers

5R00HD105984

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006498

Identifier Type: -

Identifier Source: org_study_id