PI-SUAS - Impact Evaluation of Home Visits

NCT06971926 | Not Yet Recruiting DMC

• 1 other identifier: TTS-2024-71139
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

early child development; home visit programs; impact evaluation; parenting practices

Outcome Measures

Primary Outcomes (1)

• Overall child development

  Children's overall development will be assessed using the Caregiver Reported Child Development Index - Credi Long form overall score. The scale ranges from 0 to 100, where a higher score indicates a child's development is progressing more positively. However, CREDI. Z-scores will be used to calculate and interpret the effect sizes.

  Age 2 - 3 years in after 12 months of intervention

Secondary Outcomes (1)

• Parenting practices

  Assessment after 12 months of intervention

Study Arms (2)

Control Group

NO INTERVENTION

Eligible children who will not receive the intervention (home-visits) during the study period

Home visit group

EXPERIMENTAL

Home visit to improve parenting practives and child development

Behavioral: Home visist

Interventions

Home visist BEHAVIORAL

Caregivers and children will receive home visits twice a month delivered by the social assistance service within the PI-SUAS/CF during 12 months

Also known as: PI-SUAS Home visits

Home visit group

Eligibility Criteria

• Age: 18 Months - 22 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Children who receive or received home-visits from the social assistance PI-SUAS/CF

Sponsors & Collaborators

• University of Sao Paulo: lead
• Grand Challenges Canada: collaborator
• Fundação Maria Cecília Souto Vidigal: collaborator

Study Officials

• Alexandra Brentani - Principal Investigator, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Brentani, PhD

CONTACT

+551126618803; alexandra@usp.br

Luana Bessa, MD

CONTACT

551130919201; lubessa79@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The intervention will be delivered to 50% of the participants during year 1. The rest will remain as a control group during year 1 and will receive the intervention after endline data collection

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share