PI-SUAS - Impact Evaluation of Home Visits

Background: Early childhood, particularly from 0-36 months, represents a critical period of human development marked by rapid growth and skill acquisition. The brain undergoes accelerated development and is highly receptive to stimuli and experiences, which leave lasting marks and influence the individual's future. A nurturing environment-characterized by sensitivity to the child's health and nutritional needs, caregiver responsiveness, and emotional support-is especially vital in early childhood, in this period. Such an environment safeguards the child and their development from the detrimental effects of adverse socioeconomic conditions. Among early childhood development (ECD) programs, home visits have proven to be an effective strategy for promoting positive parenting and fostering child development, supported by long-term evidence. Objective: This study aims to assess the impact of the enhanced methodology of the Primeira Infância no SUAS/Programa Criança Feliz (PI-SUAS/CF) on early childhood development outcomes through a randomized controlled trial (RCT). Methods: A randomized controlled trial will be conducted across 6 municipalities in Brazil, focusing on vulnerable populations. Participants will include eligible families with children aged 18-20 months who are not yet enrolled in the program. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive home visits based on the revised PI-SUAS/CF methodology, which emphasizes age- and culturally appropriate practices, caregiver responsiveness, and emotional support for 12 months. The control group will receive standard social assistance services without the enhanced home-visiting methodology. Primary outcomes will include cognitive, language, and socio-emotional development, assessed using validated tools. Secondary outcomes will focus on the quality of caregiver-child interactions and parental practices. Data will be collected at baseline and endline. Results: It is hypothesized that the revised methodology will lead to significant improvements in child development outcomes compared to the control group. The flexible, adaptable approach is expected to enhance the quality and effectiveness of home visits across diverse contexts. Conclusion: This trial will provide robust evidence on the effectiveness of an improved home-visiting methodology in promoting early childhood development among vulnerable populations. The findings will inform policy decisions and support the scaling of early childhood interventions globally.

NCT Number	NCT06971926
Lead Sponsor	University of Sao Paulo Collaborators: Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal
Conditions	Healthy
Enrollment	1,600 participants
Start Date	2025-06-15
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-31