Home Visiting Programs to Improve Early Childhood Development and Maternal Mental Health
Condition: Child Development; Mental Health Wellness 1
Study type: Interventional

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 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.
    

Intervention name(s): Home visiting program (Jamaica curriculum)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care