An interventional study of Familia Imara in Intimate Partner Violence (IPV), sponsored by Saini Das. Recruiting at 1 site in Tanzania. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Saini Das · Not applicable, Interventional, and Prevention
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.
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.
This is the only study on the registry with Saini Das as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be offered a parenting program delivered within their community, consisting of two sessions per month over approximately 10 months.
Behavioral: Familia Imara
Participants will not receive any intervention in Cohort 1 and will serve as a comparison group.
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.
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 11 months, 22 months
IPV attitudes
Attitudes toward intimate partner violence will be reported by mothers and fathers using a tool adapted from the Demographic and Health Surveys (DHS). The instrument assesses whether respondents believe a man is justified in hitting or beating his wife in specific situations. Items are measured using a Likert-type response scale (e.g., strongly agree to strongly disagree). Responses will be coded and summed to create a composite score, with higher scores indicating less accepting attitudes toward intimate partner violence.
Time frame: Baseline, 11 months, 22 months
Knowledge of child nutrition and development
Knowledge of child nutrition and development will be reported by mothers and fathers using a structured questionnaire developed by the study team. The instrument includes items on developmental milestones, early learning and responsive caregiving, child nutrition, and infant and young child feeding practices. Respondents will answer a series of true/false and short-answer questions. Two separate indicators will be derived: (1) knowledge of child nutrition, and (2) knowledge of child development. Each indicator will be analyzed separately, with higher scores indicating greater knowledge in the respective domain.
Time frame: Baseline, 11 months, 22 months
Parenting attitudes
Attitudes toward parenting will be reported by mothers and fathers using a tool developed by Jeong et al. in Tanzania. The tool captures agreement with statements related to developmentally appropriate parenting, general parenting practices, and discipline approaches. Higher scores reflect more positive attitudes toward parenting.
Time frame: Baseline, 11 months, 22 months
Parental stimulation
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. Higher scores indicating greater parental engagement in stimulation activities.
Time frame: Baseline, 11 months, 22 months
Couples' communication
The frequency of communication between partners will be reported by mothers and fathers using a tool developed by the study team. Respondents will rate how often they communicated about a range of topics (e.g., nutrition, child discipline, household finances) with their partner over the past week. Higher scores indicate more frequent communication between partners.
Time frame: Baseline, 11 months, 22 months
Gender attitudes score
Gender attitudes reported by mothers and fathers regarding gender norms around childcare and domestic responsibilities, household equity, and power dynamics within partner relationships. This measure was developed by Jeong et al. in this context. Higher scores indicate more gender-equitable attitudes.
Time frame: Baseline, 11 months, 22 months
Plan to share: No
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