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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

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 groups in NCT02704000
Study groupRoleWhat they receive
ControlNo interventionNo interventions - only baseline and endline assessments to be conducted at children's home.
Home visits by CDAsExperimentalIntervention: 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 CHWsExperimentalIntervention: 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.

  1. 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)
  1. Maternal depression risk as assessed by the Edinburgh Scale

    The Edinburgh Scale assesses the risk of maternal depression

    Measured: 12 months after program initiation

  2. 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

  3. 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.

  1. First posted9 Mar 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2016
  4. Study completionNov 2019

Resources

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)
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 33496330
  • Smith 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

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.

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