Father-Inclusive Parenting Intervention in Mwanza, Tanzania

Emory University

Status: Active, not recruiting

Conditions: Parents

Treatments: Behavioral: Familia Bora

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07025447

STUDY00006498

5R00HD105984 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 792 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria for couples:

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.

Exclusion Criteria:

• Need to satisfy the inclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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792 participants in 2 patient groups

Familia Bora

Experimental group

Description:

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

Treatment:

Behavioral: Familia Bora

Control Group

No Intervention group

Description:

Participants will not receive any intervention.