Intimate Partner Violence (IPV)NCT07574567
Familia Imara: A Parenting Program to Reduce Family Violence in Tanzania
A study testing Familia Imara in people with Intimate Partner Violence (IPV), run by Saini Das at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence (IPV)
- What is being tested?
- Familia Imara
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,216 participants
- Where
- 1 siteTanzania
- Study dates
- 2 May 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Need to satisfy the inclusion criteria
- Expecting to relocate in the next year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gerry Mshana, PhD contact
Tanzania1 site, 1 recruiting
- Recruiting
National Institute for Medical Research (NIMR)
Dar es Salaam
Gerry Mshana, gerrymshana@hotmail.com
Joshua Jeong
About this study
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
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.
Read the 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.
- Conditions
- Intimate Partner Violence (IPV)
- Being tested
- Familia Imara
- Keywords
- Intimate Partner Violence, Couples, Parenting, Harsh Discipline, Early Childhood Development, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familia ImaraBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Familia Imara | Experimental | Participants will be offered a parenting program delivered within their community, consisting of two sessions per month over approximately 10 months. Receives: Behavioral: Familia Imara |
| Waitlist Control Group | No intervention | Participants will not receive any intervention in Cohort 1 and will serve as a comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 11 months, 22 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 11 months, 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start2 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner Violence (IPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saini Das
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, National Institute of Medical Research, The Prevention Collaborative, Global Communities, Kivulini Women's Right Organization
- Responsible party
- Sponsor-investigator, Saini Das, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574567
- Sponsor's protocol ID
- 2025P013910
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07574567
- Acronym / sponsor ID
- 2025P013910
- Conditions
- Intimate Partner Violence (IPV)
- Keywords
- Intimate Partner Violence, Couples, Parenting, Harsh Discipline, Early Childhood Development, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,216 participants (estimated)
- Lead sponsor
- Saini DasUniversity, hospital or other
- Collaborators
- Emory University, National Institute of Medical Research, The Prevention Collaborative, Global Communities, Kivulini Women's Right Organization
- Study start
- 2 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familia Imara | Experimental | Behavioral: Familia ImaraParticipants will be offered a parenting program delivered within their community, consisting of two sessions per month over approximately 10 months. |
| Waitlist Control Group | No intervention | –Participants will not receive any intervention in Cohort 1 and will serve as a comparison group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Need to satisfy the inclusion criteria
- Expecting to relocate in the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Familia ImaraFamilia 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. | Behavioural | Familia Imara |
Primary outcome
Maternal intimate partner violence victimization
Time frame: Baseline, 11 months, 22 months
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
Time frame: Baseline, 11 months, 22 months
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
Time frame: Baseline, 11 months, 22 months
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
Time frame: Baseline, 11 months, 22 months
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerry Mshana, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Familia Imara in people with Intimate Partner Violence (IPV), run by Saini Das at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Jeong, ScD (404-727-2671, joshua.jeong@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal intimate partner violence victimization (time frame: Baseline, 11 months, 22 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.