NCT07574567

Brief Summary

This cluster-randomized controlled trial will evaluate the effectiveness, implementation, and scalability of Familia Imara, a group-based, couples-focused, community health worker (CHW)-delivered parenting program, on reducing intimate partner violence (IPV), harsh discipline, and improving child development and nutrition outcomes in the Mara and Geita regions of Tanzania. Villages will be randomly assigned to either an intervention or control arm. The study will be implemented in two sequential cohorts. In Cohort 1, a traditional randomized controlled trial will compare intervention villages receiving the program to control villages receiving no intervention (waitlist control), with delivery supported primarily by implementing partners in collaboration with government supervisors. In Cohort 2, the same villages will retain their original assignment. Intervention villages will receive the program under a government-led delivery model to assess scalability and integration into existing systems, while control villages will transition from waitlist to receive the intervention. Evidence generated will inform policy and practice for preventing family violence and promoting early childhood development at scale.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,216

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Apr 2028

First Submitted

Initial submission to the registry

May 1, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

Intimate Partner ViolenceCouplesParentingHarsh DisciplineEarly Childhood DevelopmentNutrition

Outcome Measures

Primary Outcomes (4)

  • Maternal intimate partner violence victimization

    Mothers will report on their experiences of intimate partner violence in the past six months using a standardized set of violent acts perpetrated by their partner (i.e., the child's father), adapted from the World Health Organization's multi-country study on women's health and domestic violence against women. The primary IPV indicator will be a proportion reflecting the percentage of mothers who report experiencing any form of IPV. In addition, we will calculate separate binary indicators for each type of IPV (physical, sexual, and emotional).

    Baseline, 11 months, 22 months

  • Child dietary diversity

    Child dietary diversity will be reported by mothers as the number of food groups (out of eight) consumed by the child in the previous 24 hours, following World Health Organization (WHO) guidelines. This measure is assessed in children aged six months and older, with higher scores indicating a greater likelihood of achieving a nutritionally adequate diet.

    Baseline, 11 months, 22 months

  • Parental harsh disciplinary practices

    Parental disciplinary practices will be self-reported by both mothers and fathers in terms of harsh disciplinary practices (e.g., shook the child, shouted at the child) used by the parent towards the child in the past month. Items were adapted from the Child Discipline Module of the Multiple Indicator Cluster Survey. The primary indicator will be a proportion for mothers and fathers who used any harsh disciplinary practices, with separate indicators by type (physical, verbal).

    Baseline, 11 months, 22 months

  • Caregiver Reported Early Development Instrument (CREDI) long form

    Early child development will be measured using the Caregiver Reported Early Development Instrument (CREDI) long form. It relies on parental reporting and assesses four domains of early developmental milestones: motor, language, cognitive, and socioemotional development. Higher scores reflect a greater number of age-appropriate developmental skills as reported by caregivers.

    Baseline, 11 months, 22 months

Secondary Outcomes (6)

  • IPV attitudes

    Baseline, 11 months, 22 months

  • Knowledge of child nutrition and development

    Baseline, 11 months, 22 months

  • Parenting attitudes

    Baseline, 11 months, 22 months

  • Parental stimulation

    Baseline, 11 months, 22 months

  • Couples' communication

    Baseline, 11 months, 22 months

  • +1 more secondary outcomes

Study Arms (2)

Familia Imara

EXPERIMENTAL

Participants will be offered a parenting program delivered within their community, consisting of two sessions per month over approximately 10 months.

Behavioral: Familia Imara

Waitlist Control Group

NO INTERVENTION

Participants will not receive any intervention in Cohort 1 and will serve as a comparison group.

Interventions

Familia ImaraBEHAVIORAL

Familia Imara is a couples-based, group parenting program delivered by trained community health workers (CHWs) in community settings. In each village, one male and one female CHW are assigned to facilitate the program. They co-facilitate joint couples' sessions and lead separate peer group sessions for mothers and fathers in a gender-matched format. Sessions are approximately 2 hours in duration and occur twice monthly over a 10-month period. Curriculum content includes: prevention of IPV and harsh discipline, play and early learning stimulation, nutrition and infant and young child feeding practices, couples' communication and conflict resolution, stress management, power, and gender norms and roles.

Familia Imara

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The household has a child aged 0-24 months at enrollment
  • The child has a primary female caregiver (i.e., mother) and a primary male caregiver (i.e., father) who are in a partnered relationship
  • Primary female caregiver, primary male caregiver, and child reside together in the same household
  • Both caregivers provide written informed consent for themselves and their child to participate in the study

You may not qualify if:

  • Expecting to relocate in the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Medical Research (NIMR)

Dar es Salaam, Tanzania

RECRUITING

Central Study Contacts

Joshua Jeong, ScD

CONTACT

Gerry Mshana, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 8, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations