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Recruiting NCT07574567

Familia Imara: A Parenting Program to Reduce Family Violence in Tanzania

No phase Interventional Intimate Partner Violence (IPV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Familia Imara.
Who it may be relevant to
Registry conditions: Intimate Partner Violence (IPV). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cluster Randomized Controlled Trial to Assess the Effectiveness of Familia Imara in Preventing Violence Against Women and Children and Improving Child Nutrition and Development in Tanzania

Overview

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.

Detailed description

IPV is a major global public health concern affecting millions of women worldwide, with caregivers of young children particularly vulnerable. IPV undermines women's health and wellbeing and disrupts caregiving environments, parenting practices, and early child development. While parenting interventions have demonstrated benefits for child outcome, few explicitly integrate violence prevention and gender-transformative components. This study is a cluster-randomized controlled trial designed to generate rigorous evidence on the effectiveness, implementation, and scalability of Familia Imara, a couples-focused, group-based parenting intervention that integrates nurturing care content with gender-transformative and violence prevention approaches and is delivered by CHWs.

The study will be conducted in the Mara and Geita regions of Tanzania using a multi-stage sampling strategy, including ward, village, and household selection. Villages will be randomly assigned to either the intervention or control arm. In each village, approximately 14 couples with a child under two years of age will be enrolled per cohort.

The trial will be implemented in two sequential cohorts to assess both effectiveness and pathways to scale. In Cohort 1, intervention villages will receive the Familia Imara program delivered by trained CHWs. Training, mentorship, and supervision of CHWs will be led primarily by implementing partners, in collaboration with government supervisors. Control villages will serve as a waitlist comparison group and will not receive the intervention during this phase. In Cohort 2, the same villages will retain their original study arm assignment. In intervention villages, the same CHWs will deliver the program to newly formed groups of eligible caregivers. During this phase, re-training, mentorship, and supervision will be led primarily by government supervisors, with reduced involvement from implementing partners, to assess the feasibility of scale-up and integration into existing government systems. In control villages, the waitlist control condition will end, and CHWs from these villages will be newly trained to deliver the intervention. Program delivery in these villages will follow a model similar to Cohort 1, with joint involvement of implementing partners and government supervisors.

The Familia Imara program consists of group sessions delivered twice monthly over approximately 10 months, including a mixture of joint couples' sessions and separate peer group sessions for mothers and fathers. Core content includes responsive caregiving, play and communication, nutrition and infant and young child feeding, positive discipline, gender norms, non-violent conflict resolution, and prevention of IPV.

Cohort 1 will enroll approximately 2,072 couples (4,144 individuals), consisting of 2,072 mothers and 2,072 fathers who are partnered with each other. In Cohort 2, an additional 1,036 new couples (2,072 individuals) will be enrolled in the intervention villages that previously received the program. Quantitative surveys will be administered at baseline and follow-up time points to assess changes in outcomes within and between study arms over time, as well as differences across delivery models.

Interventions

  • Behavioral Familia Imara
    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 ha

Primary outcome measures

  • Maternal intimate partner violence victimization [Time frame: Baseline, 11 months, 22 months]
  • Child dietary diversity [Time frame: Baseline, 11 months, 22 months]
  • Parental harsh disciplinary practices [Time frame: Baseline, 11 months, 22 months]
  • Caregiver Reported Early Development Instrument (CREDI) long form [Time frame: Baseline, 11 months, 22 months]
Secondary outcome measures (6)
  • IPV attitudes [Time frame: Baseline, 11 months, 22 months]
  • Knowledge of child nutrition and development [Time frame: Baseline, 11 months, 22 months]
  • Parenting attitudes [Time frame: Baseline, 11 months, 22 months]
  • Parental stimulation [Time frame: Baseline, 11 months, 22 months]
  • Couples' communication [Time frame: Baseline, 11 months, 22 months]
  • Gender attitudes score [Time frame: Baseline, 11 months, 22 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Need to satisfy the inclusion criteria
  • Expecting to relocate in the next year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Prevention

Study locations

Tanzania · 1 center
  • National Institute for Medical Research (NIMR) — Dar es Salaam

Identifiers

NCT: NCT07574567 · 2025P013910

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗