About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Need to satisfy the inclusion criteria
Expecting to relocate in the next year
Trial design
Single group
Treatments tested in this trial
Familia Imara
BehavioralFamilia 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
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).
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Saini Das
Lead sponsor
George Washington University
Sponsor institution
Emory University
Collaborator
National Institute of Medical Research
Collaborator
The Prevention Collaborative
Collaborator
Global Communities
Collaborator
Kivulini Women's Right Organization
Collaborator