ParentsNCT07025447
Father-Inclusive Parenting Intervention in Mwanza, Tanzania
A study testing Familia Bora in people with Parents, run by Emory University at 2 sites in 2 countries.
Trial summary
This cluster-randomized controlled trial aims to evaluate the impact of a couples-based parenting program, "Familia Bora," on mothers' and fathers' parenting, couples' relationships, gender, and early child development in the Mwanza Region, Tanzania. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parents
- What is being tested?
- Familia Bora
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 May 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each individual is an adult aged 18-65 years
- Each individual is the primary female or male caregiver of a child younger than 2 years of age
- The two individuals are currently in a marital or partnered relationship with each other
- Both individuals have lived in the same household as each other and the child during the past month, and
- Both individuals provide written informed consent to participate in the study.
Who cannot join
- Need to satisfy the inclusion criteria
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Cluster-Randomized Controlled Trial of a Father-Inclusive Parenting Intervention in Mwanza, Tanzania
This cluster-randomized controlled trial aims to evaluate the impact of a couples-based parenting program, "Familia Bora," on mothers' and fathers' parenting, couples' relationships, gender, and early child development in the Mwanza Region, Tanzania. Additionally, this study aims to assess the program's implementation and identify factors influencing its quality and effectiveness.
Trained community health workers will deliver the program by facilitating weekly peer group sessions in their villages. Twelve couples with a child under two years old will be enrolled in each village. The program will cover various topics, including responsive caregiving, positive discipline, stress management, healthy couples' communication, nutrition, and gender.
Read the detailed description
An estimated 43% of children under five in low- and middle-income countries are at risk of not achieving their developmental potential, with the burden highest in sub-Saharan Africa. While there is robust evidence on the effectiveness of parenting interventions for improving nurturing care and early childhood development (ECD), the vast majority of existing programs have targeted mothers exclusively. Fathers are often excluded from parenting programs, even though evidence highlights their vital contributions to child and family wellbeing.
This cluster-randomized controlled trial will evaluate the impacts and implementation quality of a newly developed, culturally-responsive, gender-transformative, and father-inclusive parenting intervention ("Familia Bora"). The study will be implemented in 33 villages across Misungwi and Sengerema districts in Mwanza Region, Tanzania. Half of the villages will be randomly assigned to the intervention (17 villages) versus control group (16 villages) with stratification by district. The program will train community health workers (CHWs) to deliver the program to groups of 12 randomly selected couples per village.
Familia Bora primarily involves group sessions covering various topics, including responsive parenting, positive discipline, couples' communication, stress management, and gender roles in family caregiving. These group sessions will be held at a convenient community location on a weekly basis for approximately five months.
In total, the trial will enroll 396 couples with young children (i.e., 396 men and 396 female partners). Quantitative surveys will be conducted with fathers and mothers at baseline and endline to assess outcomes, including maternal and paternal parenting practices and attitudes, gender attitudes, relationship dynamics, and early childhood development. Quantitative data will be collected from CHWs at baseline and endline to assess program-related changes in their knowledge, attitudes, and skills. In addition to the quantitative evaluation, qualitative methods will be used to evaluate implementation processes and participant perspectives through midline and endline in-depth interviews with a subsample of caregivers and CHWs, community leaders, and other relevant stakeholders across the intervention villages. The primary endpoint for the trial will be the endline assessment, or 6 months post-baseline.
Following completion of the core Familia Bora program, intervention villages will be re-randomized (stratified by district) to receive either a 3-month booster extension or no additional intervention. The booster will consist of monthly group session and home visits focused particularly on reinforcing responsive caregiving and early learning. A secondary follow-up assessment will be conducted at 12 months post-baseline to evaluate the effects of the booster component and sustainability of intervention impacts on the short-term.
- Conditions
- Parents
- Being tested
- Familia Bora
- Keywords
- Fatherhood, Parenting, Caregiving, Early childhood development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familia BoraBehavioural
Familia Bora is a couples-based group parenting program. Twelve couples will be enrolled in each village and form one parenting group. CHWs will be trained to deliver the intervention.
The program will involve 17 group sessions. Each session is expected to last 1.5 hours and will be delivered weekly for approximately 5 months. Each session will focus on various topics, including responsive caregiving, positive discipline, stress management, child nutrition, couples' communication, non-violent conflict resolution strategies in relationships, gender equity, and early child care and education. In addition to the weekly group parenting sessions, CHWs will be encouraged to conduct home visits to engage couples who miss sessions, reinforce key messages, and provide extra support for caregivers and children as needed.
Following completion of the core intervention, intervention villages will be re-randomized to either receive a 3-month booster or no additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| Familia Bora | Experimental | Participants will be offered a parenting group program available in their community, with weekly scheduled sessions for approximately 5 months. Receives: Behavioral: Familia Bora |
| Control Group | No intervention | Participants will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stimulation score
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. The total score ranges from 0 to 7, with higher scores indicating greater parental engagement in stimulation activities.
Measured: Baseline, 6 months (primary endpoint), 12 months (secondary follow-up)
Secondary outcomes (10)
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, 6 months, 12 months
Variety of early learning materials score
Play and learning materials will be measured using the Early Childhood Development Module of the Multiple Indicator Cluster Survey. Includes types of different objects children play with at home (e.g., homemade toys, manufactured toys, household objects) as well as the number of books present in the household. Play and learning modules will be reported by the mother.
Measured: Baseline, 6 months, 12 months
Parental disciplinary practices score
Maternal and paternal disciplinary practices will be reported in terms of harsh punishment (e.g., shook the child, shouted at the child) and positive disciplinary practices (e.g., explained why the behavior was wrong) used by the parent towards the child. Items were adapted from the Child Discipline Module of the Multiple Indicator Cluster Survey, with additional items related to verbal harsh punishment and positive reinforcement created by the study team based on formative research within this study context. Separate indicators will be created for the use of any harsh disciplinary practices or any positive disciplinary practices. Higher values on each indicator will reflect greater use of the respective disciplinary practice (i.e., harsh or positive).
Measured: Baseline, 6 months, 12 months
Level of father involvement in childcare and household chores
The level of the fathers' involvement will be self-reported by men as well as through maternal reports about their male partners regarding the number of childcare and household activities performed by the father to support the young child, female partner, and family more broadly (e.g., bathing the child, providing money to the partner, washing dishes/clothes). Measure developed and validated by the authors. Higher scores indicate greater fathers' involvement in childcare activities and household chores.
Measured: Baseline, 6 months, 12 months
Parenting attitudes score
Attitudes toward parenting will be reported by mothers and fathers using a tool developed by the study team, informed by formative qualitative research conducted in the study context. 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, 6 months, 12 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 the study team based on formative research in this context. Higher scores indicate more gender-equitable attitudes
Measured: Baseline, 6 months, 12 months
Decision-making score
Mothers and fathers will report on who in their family (mother, father, someone else, or shared) has the final say about decisions across various family domains. Items were adapted from the decision-making module of the Demographic Health Surveys. Women's decision-making autonomy will be scored as the number of domains in which she is involved, with higher scores indicating greater participation.
Measured: Baseline, 6 months, 12 months
Parenting stress score
Parenting distress will be reported by mothers and fathers using the Parenting Stress Index-Short Form, Parental Distress subscale. The scale is based on a series of statements that parents can agree or disagree with, and the scores are calculated by summing the responses to the items. Higher scores indicate greater levels of stress.
Measured: Baseline, 6 months, 12 months
Maternal intimate partner violence victimization
Mothers will report on their experiences of intimate partner violence in the past three 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, 6 months, 12 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, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start21 May 2025
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanzania Home Economics Organization, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Joshua Jeong, Emory University
- Investigators
- Joshua Jeong, ScD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025447
- Sponsor's protocol ID
- STUDY00006498
- Other IDs
- 5R00HD105984, 2025P010300
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator will share de-identified Individual participant data that underlie the results reported in the primary trial article.
Publications
Jeong J, Lambert VJ, Sangarara G, Bhojani A, Joseph J, Joachim D. A father-inclusive, gender-transformative parenting program to strengthen parenting and partner relationships among couples with young children in Mwanza, Tanzania (Familia Bora): a study protocol for a cluster-randomized controlled trial and mixed-methods process evaluation. BMC Pediatr. 2026 Apr 15;26(1):494. doi: 10.1186/s12887-026-06833-3.
PubMed 41987139
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-Randomized Controlled Trial of a Father-Inclusive Parenting Intervention in Mwanza, Tanzania
- ClinicalTrials.gov ID
- NCT07025447
- Acronym / sponsor ID
- STUDY00006498
- Conditions
- Parents
- Keywords
- Fatherhood, Parenting, Caregiving, Early childhood development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Tanzania Home Economics Organization, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 17 Jun 2025 (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 aims to evaluate the impact of a couples-based parenting program, "Familia Bora," on mothers' and fathers' parenting, couples' relationships, gender, and early child development in the Mwanza Region, Tanzania. Additionally, this study aims to assess the program's implementation and identify factors influencing its quality and effectiveness.
Trained community health workers will deliver the program by facilitating weekly peer group sessions in their villages. Twelve couples with a child under two years old will be enrolled in each village. The program will cover various topics, including responsive caregiving, positive discipline, stress management, healthy couples' communication, nutrition, and gender.
Detailed description
An estimated 43% of children under five in low- and middle-income countries are at risk of not achieving their developmental potential, with the burden highest in sub-Saharan Africa. While there is robust evidence on the effectiveness of parenting interventions for improving nurturing care and early childhood development (ECD), the vast majority of existing programs have targeted mothers exclusively. Fathers are often excluded from parenting programs, even though evidence highlights their vital contributions to child and family wellbeing.
This cluster-randomized controlled trial will evaluate the impacts and implementation quality of a newly developed, culturally-responsive, gender-transformative, and father-inclusive parenting intervention ("Familia Bora"). The study will be implemented in 33 villages across Misungwi and Sengerema districts in Mwanza Region, Tanzania. Half of the villages will be randomly assigned to the intervention (17 villages) versus control group (16 villages) with stratification by district. The program will train community health workers (CHWs) to deliver the program to groups of 12 randomly selected couples per village.
Familia Bora primarily involves group sessions covering various topics, including responsive parenting, positive discipline, couples' communication, stress management, and gender roles in family caregiving. These group sessions will be held at a convenient community location on a weekly basis for approximately five months.
In total, the trial will enroll 396 couples with young children (i.e., 396 men and 396 female partners). Quantitative surveys will be conducted with fathers and mothers at baseline and endline to assess outcomes, including maternal and paternal parenting practices and attitudes, gender attitudes, relationship dynamics, and early childhood development. Quantitative data will be collected from CHWs at baseline and endline to assess program-related changes in their knowledge, attitudes, and skills. In addition to the quantitative evaluation, qualitative methods will be used to evaluate implementation processes and participant perspectives through midline and endline in-depth interviews with a subsample of caregivers and CHWs, community leaders, and other relevant stakeholders across the intervention villages. The primary endpoint for the trial will be the endline assessment, or 6 months post-baseline.
Following completion of the core Familia Bora program, intervention villages will be re-randomized (stratified by district) to receive either a 3-month booster extension or no additional intervention. The booster will consist of monthly group session and home visits focused particularly on reinforcing responsive caregiving and early learning. A secondary follow-up assessment will be conducted at 12 months post-baseline to evaluate the effects of the booster component and sustainability of intervention impacts on the short-term.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familia Bora | Experimental | Behavioral: Familia BoraParticipants will be offered a parenting group program available in their community, with weekly scheduled sessions for approximately 5 months. |
| Control Group | No intervention | –Participants will not receive any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Each individual is an adult aged 18-65 years
- Each individual is the primary female or male caregiver of a child younger than 2 years of age
- The two individuals are currently in a marital or partnered relationship with each other
- Both individuals have lived in the same household as each other and the child during the past month, and
- Both individuals provide written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Need to satisfy the inclusion criteria
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 BoraFamilia Bora is a couples-based group parenting program. Twelve couples will be enrolled in each village and form one parenting group. CHWs will be trained to deliver the intervention. The program will involve 17 group sessions. Each session is expected to last 1.5 hours and will be delivered weekly for approximately 5 months. Each session will focus on various topics, including responsive caregiving, positive discipline, stress management, child nutrition, couples' communication, non-violent conflict resolution strategies in relationships, gender equity, and early child care and education. In addition to the weekly group parenting sessions, CHWs will be encouraged to conduct home visits to engage couples who miss sessions, reinforce key messages, and provide extra support for caregivers and children as needed. Following completion of the core intervention, intervention villages will be re-randomized to either receive a 3-month booster or no additional intervention. | Behavioural | Familia Bora |
Primary outcome
Parental stimulation score
Time frame: Baseline, 6 months (primary endpoint), 12 months (secondary follow-up)
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. The total score ranges from 0 to 7, with higher scores indicating greater parental engagement in stimulation activities.
10 secondary outcomes
Caregiver Reported Early Development Instrument (CREDI) long form
Time frame: Baseline, 6 months, 12 months
Variety of early learning materials score
Time frame: Baseline, 6 months, 12 months
Parental disciplinary practices score
Time frame: Baseline, 6 months, 12 months
Level of father involvement in childcare and household chores
Time frame: Baseline, 6 months, 12 months
Parenting attitudes score
Time frame: Baseline, 6 months, 12 months
Gender attitudes score
Time frame: Baseline, 6 months, 12 months
Decision-making score
Time frame: Baseline, 6 months, 12 months
Parenting stress score
Time frame: Baseline, 6 months, 12 months
Maternal intimate partner violence victimization
Time frame: Baseline, 6 months, 12 months
Child dietary diversity
Time frame: Baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 41987139Jeong J, Lambert VJ, Sangarara G, Bhojani A, Joseph J, Joachim D. A father-inclusive, gender-transformative parenting program to strengthen parenting and partner relationships among couples with young children in Mwanza, Tanzania (Familia Bora): a study protocol for a cluster-randomized controlled trial and mixed-methods process evaluation. BMC Pediatr. 2026 Apr 15;26(1):494. doi: 10.1186/s12887-026-06833-3.
- Individual participant dataSharing planned: Yes. The investigator will share de-identified Individual participant data that underlie the results reported in the primary trial article.
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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. This study is not recruiting at the moment.
Joshua Jeong, ScD principal investigator
Emory University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Familia Bora in people with Parents, run by Emory University at 2 sites in 2 countries.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stimulation score (time frame: Baseline, 6 months (primary endpoint), 12 months (secondary follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025447, which also lists 1 linked publication.
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 8 Sep 2026.