Father-Inclusive Parenting Intervention in Mwanza, Tanzania

NCT07025447 | Active Not Recruiting

• 3 other identifiers: STUDY000064985R00HD1059842025P010300
• Study Type: interventional
• Target: 792
• Locations: 2 countries
• Sites: 2

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.

Conditions

Parents

Keywords

Fatherhood; Parenting; Caregiving; Early childhood development

Outcome Measures

Primary Outcomes (1)

• Parental stimulation score

  Maternal and paternal stimulation practices will be measured by the Family Care Indicators (FCI), which are reported in terms of the number of developmentally-enriching activities that the parent engaged with the young child in the past week (e.g., singing, telling stories). Activities adapted from the Family Care Indicators. The total score ranges from 0 to 7, with higher scores indicating greater parental engagement in stimulation activities.

  Baseline, 6 months (primary endpoint), 12 months (secondary follow-up)

Secondary Outcomes (10)

• Caregiver Reported Early Development Instrument (CREDI) long form

  Baseline, 6 months, 12 months

• Variety of early learning materials score

  Baseline, 6 months, 12 months

• Parental disciplinary practices score

  Baseline, 6 months, 12 months

• Level of father involvement in childcare and household chores

  Baseline, 6 months, 12 months

• Parenting attitudes score

  Baseline, 6 months, 12 months

Other Outcomes (2)

• Child epigenetic pace of aging

  6 months, 12 months

• Child DNA methylation

  6 months, 12 months

Study Arms (2)

Familia Bora

EXPERIMENTAL

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

Behavioral: Familia Bora

Control Group

NO INTERVENTION

Participants will not receive any intervention.

Interventions

Familia Bora BEHAVIORAL

Familia Bora is a couples-based group parenting program. 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, 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. Following completion of the core intervention, intervention villages will be re-randomized to either receive a 3-month booster or no additional intervention.

Familia Bora

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Tanzania Home Economics Organization: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30329, United States

Location

Communities in Mwanza,Tanzania

Mwanza, Tanzania

Location

Related Publications (1)

• Jeong J, Lambert VJ, Sangarara G, Bhojani A, Joseph J, Joachim D. A father-inclusive, gender-transformative parenting program to strengthen parenting and partner relationships among couples with young children in Mwanza, Tanzania (Familia Bora): a study protocol for a cluster-randomized controlled trial and mixed-methods process evaluation. BMC Pediatr. 2026 Apr 15. doi: 10.1186/s12887-026-06833-3. Online ahead of print.

  PMID: 41987139 DERIVED

Study Officials

• Joshua Jeong, ScD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to Joshua.jeong@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1); TA (1)