Child DevelopmentNCT02704000
Home Visiting Programs to Improve Early Childhood Development and Maternal Mental Health
A study testing Home visiting program (Jamaica curriculum) in people with Child Development and Mental Health Wellness 1, run by University of Sao Paulo.
Trial summary
This study evaluates the efficacy and cost-effectiveness of two platforms for delivering home visiting programs in the poor urban setting of Sao Paulo's western region: a program delivered by a newly trained cadre of Child Development Agents, and a program delivered by Community Health Agents employed by the… Read more about this study
- Who is it for?
- Ages 9 to 17 months
- Conditions the study is for
- Child Development, Mental Health Wellness 1
- What is being tested?
- Home visiting program (Jamaica curriculum)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2019
- 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 9 to 17 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- enrolled in Western Region Cohort study
Who cannot join
- not enrolled in Western Region Cohort study
- not in target age range
About this study
Official title: Home Visiting Programs to Improve Early Childhood Development and Maternal Mental Health - Evidence From the Western Region Cohort Project
This study evaluates the efficacy and cost-effectiveness of two platforms for delivering home visiting programs in the poor urban setting of Sao Paulo's western region: a program delivered by a newly trained cadre of Child Development Agents, and a program delivered by Community Health Agents employed by the government as part of the Family Health Strategy (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that is currently being adapted to the local context. The primary outcome of the program will be cognitive development for children aged 9 to 15 months old at baseline (21-27 months at endline) The secondary outcomes will include child physical development as well as maternal mental health.
Read the detailed description
Despite major improvements in nutrition and child survival, a large share of children growing up in poor urban areas of Brazil continue to be exposed to a substantial amount of adversity in early childhood due to exposure to pollutants, exposure to external and domestic violence, unstable family environment, maternal depression and inadequate learning opportunities.
In this project we propose to assess the feasibility, impact and cost-effectiveness of home visiting programs in poor urban families living in Sao Paulo through a small-scale randomized pilot intervention accompanied by a rigorous impact evaluation. Home visiting programs do not only have the potential to improve maternal well-being, but have also been proven effective in increasing early life stimulation and child development.
Two delivery platforms for home visiting programs will be assessed as part of this trial: 1) the introduction of a newly trained cadre of Child Development Agents (CDAs); and 2) the integration of home visiting programs into the Family Health Strategy (PSF). For the latter, we will train selected Community Health Agents (CHA) currently employed by the Brazilian government under the Family Health Strategy program on child development and provide additional financial incentives for home visits. While this second option will be less costly, the quality of the delivered interventions may not be as high as the former. The developmental impact of both delivery mechanisms will be assessed. Impact data will be combined with detailed costing data to evaluate both the effectiveness and relatively cost-effectiveness of both platforms. Quantitative data on cost and developmental impact will be combined with qualitative feedback from mothers and community workers.The successful implementation of the pilot program may lead to a larger-scale efficacy and cost-effectiveness trial in Sao Paulo in the medium run, with the ultimate objective to establish similar programs at the national level in the long run.
Several recent studies from a wide range of countries such as Bangladesh, China, India Jamaica and South Africa have demonstrated that home visiting programs can be highly effective in improving child developmental outcomes.
The principal common feature of home visiting programs is that trained child development or community agents meet with mothers or parents on a regular basis to observe the interactions between caregivers and their children, and to provide practical guidance on how to interact with them. At the core of these visiting programs is a detailed curriculum, which contains key topics of child health and development to be covered at each home visit. Detailed information and supporting materials for each session have been developed for the original Jamaica study and are currently being adapted to the Brazilian context. In this project, we will assess the effectiveness and cost-effectiveness of the newly adapted home visiting programs in the poor urban context of Sao Paulo, Brazil. Given that Brazil's middle and upper income children already benefit from a range of early childhood care services, our focus will be low-SES families. Brazil currently offers a free health care system (SUS), which is primarily used by the low SES groups, according to the latest estimates 55.6 percent of urban households in Sao Paulo - these households will be the target population for the interventions, a group of 400 low SES mother-child dyads from Sao Paulo's western region.
The poor urban neighborhoods of São Paulo are representative of a large and rapidly growing group of urban settlements in low and middle-income countries. Many of these urban settings are - just like the household in the target area - not only characterized by exposure to a large variety of environmental hazards, but often also by high prevalence of domestic and external violence and lacking social support.
The target population of this project is low SES families from Sao Paulo's western region. As part of an ongoing research study (the Western Region Project), 6000 mother-child dyads have been enrolled in a longitudinal study, which means that detailed records on family background and birth outcomes will be available to this project. The second enabling factor is the tight integration of the research project into the larger health system, which will be beneficial for the recruitment and training of health workers and when it comes to connecting with families.
The main challenge faced by the project is the general lack of stability and trust in the targeted areas. Families residing in informal settlements, often illegal, tend to move frequently, and are often not willing to receive or interact with strangers. In some neighborhoods, outsiders are not welcome at all, so that regular meetings with mothers will be difficult. The strong links with the University Hospital should help overcome these barriers; local sensitization meetings will be organized to reduce the risk of refusals and attrition.
- Conditions
- Child Development, Mental Health Wellness 1
- Being tested
- Home visiting program (Jamaica curriculum)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visiting program (Jamaica curriculum)Behavioural
Agents will deliver bi-weekly home-visits following the curriculum developed for the Jamaica intervention study by Susan Walker and colleagues. This curriculum foresees age-appropriate tasks assigned to the caregiver during each visit.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No interventions - only baseline and endline assessments to be conducted at children's home. |
| Home visits by CDAs | Experimental | Intervention: Behavioral: Home visiting program (Jamaica curriculum) Children in this intervention arm will be visited twice a months by trained child development agents (CDAs). CDAs will implement the Jamaica curriculum intervention during the home visits.. Receives: Behavioral: Home visiting program (Jamaica curriculum) |
| Home visits by CHWs | Experimental | Intervention: Behavioral: Home visiting program (Jamaica curriculum) Children in this intervention arm will be visited twice a months by trained community health workers (CHWs) trained on delivering the intervention. CHWs will implement the Jamaica curriculum intervention during the home visits.. Receives: Behavioral: Home visiting program (Jamaica curriculum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child cognitive development as measured by Griffith Scales of Mental Development
Overall cognitive development of children after 12 months of intervention.
Measured: 12 months after program initiation
Secondary outcomes (3)
Maternal depression risk as assessed by the Edinburgh Scale
The Edinburgh Scale assesses the risk of maternal depression
Measured: 12 months after program initiation
Child height relative to WHO reference curve (normalized z-score)
Home measurement of children's height - scores will be normalized using WHO reference tables.
Measured: 12 months after program initiation
Child weight relative to WHO reference curve (normalized z-score)
Home measurement of children's weight - weight in grams will be normalized using WHO reference tables.
Measured: 12 months after program initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2016
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Alexandra Brentani, University of Sao Paulo
- Investigators
- Alexandra VM Brentani, PhD, Principal investigator, Universidade de São Paulo, Faculdade de Medicina USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704000
- Sponsor's protocol ID
- 38350114.0.0000.0076
- Status last verified
- Nov 2023
- First submitted
- 24 Feb 2016
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brentani A, Walker S, Chang-Lopez S, Grisi S, Powell C, Fink G. A home visit-based early childhood stimulation programme in Brazil-a randomized controlled trial. Health Policy Plan. 2021 Apr 21;36(3):288-297. doi: 10.1093/heapol/czaa195.
PubMed 33496330Smith JA, Baker-Henningham H, Brentani A, Mugweni R, Walker SP. Implementation of Reach Up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Ann N Y Acad Sci. 2018 May;1419(1):120-140. doi: 10.1111/nyas.13678.
PubMed 29791729
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Visiting Programs to Improve Early Childhood Development and Maternal Mental Health - Evidence From the Western Region Cohort Project
- ClinicalTrials.gov ID
- NCT02704000
- Acronym / sponsor ID
- 38350114.0.0000.0076
- Conditions
- Child Development, Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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 study evaluates the efficacy and cost-effectiveness of two platforms for delivering home visiting programs in the poor urban setting of Sao Paulo's western region: a program delivered by a newly trained cadre of Child Development Agents, and a program delivered by Community Health Agents employed by the government as part of the Family Health Strategy (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that is currently being adapted to the local context. The primary outcome of the program will be cognitive development for children aged 9 to 15 months old at baseline (21-27 months at endline) The secondary outcomes will include child physical development as well as maternal mental health.
Detailed description
Despite major improvements in nutrition and child survival, a large share of children growing up in poor urban areas of Brazil continue to be exposed to a substantial amount of adversity in early childhood due to exposure to pollutants, exposure to external and domestic violence, unstable family environment, maternal depression and inadequate learning opportunities.
In this project we propose to assess the feasibility, impact and cost-effectiveness of home visiting programs in poor urban families living in Sao Paulo through a small-scale randomized pilot intervention accompanied by a rigorous impact evaluation. Home visiting programs do not only have the potential to improve maternal well-being, but have also been proven effective in increasing early life stimulation and child development.
Two delivery platforms for home visiting programs will be assessed as part of this trial: 1) the introduction of a newly trained cadre of Child Development Agents (CDAs); and 2) the integration of home visiting programs into the Family Health Strategy (PSF). For the latter, we will train selected Community Health Agents (CHA) currently employed by the Brazilian government under the Family Health Strategy program on child development and provide additional financial incentives for home visits. While this second option will be less costly, the quality of the delivered interventions may not be as high as the former. The developmental impact of both delivery mechanisms will be assessed. Impact data will be combined with detailed costing data to evaluate both the effectiveness and relatively cost-effectiveness of both platforms. Quantitative data on cost and developmental impact will be combined with qualitative feedback from mothers and community workers.The successful implementation of the pilot program may lead to a larger-scale efficacy and cost-effectiveness trial in Sao Paulo in the medium run, with the ultimate objective to establish similar programs at the national level in the long run.
Several recent studies from a wide range of countries such as Bangladesh, China, India Jamaica and South Africa have demonstrated that home visiting programs can be highly effective in improving child developmental outcomes.
The principal common feature of home visiting programs is that trained child development or community agents meet with mothers or parents on a regular basis to observe the interactions between caregivers and their children, and to provide practical guidance on how to interact with them. At the core of these visiting programs is a detailed curriculum, which contains key topics of child health and development to be covered at each home visit. Detailed information and supporting materials for each session have been developed for the original Jamaica study and are currently being adapted to the Brazilian context. In this project, we will assess the effectiveness and cost-effectiveness of the newly adapted home visiting programs in the poor urban context of Sao Paulo, Brazil. Given that Brazil's middle and upper income children already benefit from a range of early childhood care services, our focus will be low-SES families. Brazil currently offers a free health care system (SUS), which is primarily used by the low SES groups, according to the latest estimates 55.6 percent of urban households in Sao Paulo - these households will be the target population for the interventions, a group of 400 low SES mother-child dyads from Sao Paulo's western region.
The poor urban neighborhoods of São Paulo are representative of a large and rapidly growing group of urban settlements in low and middle-income countries. Many of these urban settings are - just like the household in the target area - not only characterized by exposure to a large variety of environmental hazards, but often also by high prevalence of domestic and external violence and lacking social support.
The target population of this project is low SES families from Sao Paulo's western region. As part of an ongoing research study (the Western Region Project), 6000 mother-child dyads have been enrolled in a longitudinal study, which means that detailed records on family background and birth outcomes will be available to this project. The second enabling factor is the tight integration of the research project into the larger health system, which will be beneficial for the recruitment and training of health workers and when it comes to connecting with families.
The main challenge faced by the project is the general lack of stability and trust in the targeted areas. Families residing in informal settlements, often illegal, tend to move frequently, and are often not willing to receive or interact with strangers. In some neighborhoods, outsiders are not welcome at all, so that regular meetings with mothers will be difficult. The strong links with the University Hospital should help overcome these barriers; local sensitization meetings will be organized to reduce the risk of refusals and attrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No interventions - only baseline and endline assessments to be conducted at children's home. |
| Home visits by CDAs | Experimental | Behavioral: Home visiting program (Jamaica curriculum)Intervention: Behavioral: Home visiting program (Jamaica curriculum) Children in this intervention arm will be visited twice a months by trained child development agents (CDAs). CDAs will implement the Jamaica curriculum intervention during the home visits.. |
| Home visits by CHWs | Experimental | Behavioral: Home visiting program (Jamaica curriculum)Intervention: Behavioral: Home visiting program (Jamaica curriculum) Children in this intervention arm will be visited twice a months by trained community health workers (CHWs) trained on delivering the intervention. CHWs will implement the Jamaica curriculum intervention during the home visits.. |
Who may qualify
- Ages
- 9 to 17 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- enrolled in Western Region Cohort study
Key exclusion criteria (2 listed)
- not enrolled in Western Region Cohort study
- not in target age range
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 |
|---|---|---|
| Home visiting program (Jamaica curriculum)Agents will deliver bi-weekly home-visits following the curriculum developed for the Jamaica intervention study by Susan Walker and colleagues. This curriculum foresees age-appropriate tasks assigned to the caregiver during each visit. | Behavioural | Home visits by CDAs, Home visits by CHWs |
Primary outcome
Child cognitive development as measured by Griffith Scales of Mental Development
Time frame: 12 months after program initiation
Overall cognitive development of children after 12 months of intervention.
3 secondary outcomes
Maternal depression risk as assessed by the Edinburgh Scale
Time frame: 12 months after program initiation
Child height relative to WHO reference curve (normalized z-score)
Time frame: 12 months after program initiation
Child weight relative to WHO reference curve (normalized z-score)
Time frame: 12 months after program initiation
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 30 Nov 2023.
- Results publication: PubMed 33496330Brentani A, Walker S, Chang-Lopez S, Grisi S, Powell C, Fink G. A home visit-based early childhood stimulation programme in Brazil-a randomized controlled trial. Health Policy Plan. 2021 Apr 21;36(3):288-297. doi: 10.1093/heapol/czaa195.
- Results publication: PubMed 29791729Smith JA, Baker-Henningham H, Brentani A, Mugweni R, Walker SP. Implementation of Reach Up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Ann N Y Acad Sci. 2018 May;1419(1):120-140. doi: 10.1111/nyas.13678.
- 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. This study is not recruiting at the moment.
Alexandra VM Brentani, PhD principal investigator
Universidade de São Paulo, Faculdade de Medicina USP
Questions about this trial
What is this clinical trial studying?
A study testing Home visiting program (Jamaica curriculum) in people with Child Development and Mental Health Wellness 1, run by University of Sao Paulo.
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 1 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: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Child cognitive development as measured by Griffith Scales of Mental Development (time frame: 12 months after program initiation). 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 NCT02704000, which also lists 2 linked publications.
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 30 Nov 2023.