Clinical trial NCT07025447: Father-Inclusive Parenting Intervention in Mwanza, Tanzania
Official title: Cluster-Randomized Controlled Trial of a Father-Inclusive Parenting Intervention in Mwanza, Tanzania
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parents
Keywords: Fatherhood
Parenting
Caregiving
Early childhood development
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Tanzania Home Economics Organization
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-06-17
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 32 villages across Misungwi and Sengerema districts in Mwanza Region, Tanzania. Half of the villages will be randomly assigned to the intervention versus control group 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 six months. In addition to the group sessions, CHWs will also conduct monthly home visits to reinforce key messages and provide additional individualized support to families.

In total, the trial will aim to enroll at least 384 couples with young children (i.e., 384 men and 384 their 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 in-depth interviews with CHWs and endline in-depth interviews with a subsample of caregivers and CHWs, community leaders, and other relevant stakeholders across the intervention villages.

Eligibility 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

Primary outcomes:
measure: Parental stimulation score
timeFrame: Baseline, 7 months
Secondary outcomes:
measure: Caregiver Reported Early Development Instrument (CREDI) long form
timeFrame: Baseline, 7 months
measure: Variety of early learning materials score
timeFrame: Baseline, 7 months
measure: Parental disciplinary practices score
timeFrame: Baseline, 7 months
measure: Level of father involvement in childcare and household chores
timeFrame: Baseline, 7 months
measure: Parenting attitudes score
timeFrame: Baseline, 7 months
measure: Gender attitudes score
timeFrame: Baseline, 7 months
measure: Decision-making score
timeFrame: Baseline, 7 months
measure: Parenting stress score
timeFrame: Baseline, 7 months
measure: Maternal intimate partner violence victimization
timeFrame: Baseline, 7 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Mwanza
country: Tanzania
facility: Communities in Mwanza,Tanzania
Study officials:
affiliation: Emory University
name: Joshua Jeong, ScD
role: PRINCIPAL_INVESTIGATOR
References: