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临床试验/NCT06971926
NCT06971926尚未招募不适用

Improving the Early Childhood Social Assistance National Program PI-SUAS/Criança Feliz: Impact Evaluation of the Home Visits

University of Sao Paulo0 个研究点目标入组 1,600 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,600
主要终点
Overall child development

研究概览

简要总结

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.

详细描述

Early childhood, the period from conception to six years of age, is a crucial phase of human development, marked by rapid growth and skills acquisition. The brain undergoes accelerated development and is highly receptive to stimuli and experiences, which leave lasting impressions and influence the individual's future.

The early years of the 21st century have been marked by a large body of scientific evidence on child development, demonstrating that the environment induces epigenetic, immunological, and psychosocial adaptations. These adaptations begin with conception and produce lifelong effects. In other words, factors such as the quality of the physical and social environment in which the child lives; access to healthcare; interaction and engagement from caregivers; cognitive and emotional stimulation; proper nutrition; and exposure to chronic toxic stress and adversity have a profound and lasting impact on the child's life and future.

Brain plasticity refers to the central nervous system's ability to reorganize itself in response to external stimuli, through the development of new synapses, changes in gene expression, among other processes. Studies have shown that this ability is greatest early in life and declines over time. In addition to the concept of brain plasticity, science has established that complex skills are built upon fundamental ones. Thus, a child's development is a process of maturation and interaction with the environment, resulting in sequential progression of perceptual, motor, cognitive, language, socioemotional, and self-regulation skills.

All this evidence reinforces the importance of ensuring a healthy start to life and protecting children from harmful and detrimental factors to their development. While this period of life is filled with opportunities for learning and growth, it is also a time of great vulnerability to the effects of adversity.

A nurturing environment-characterized by a home setting that is attentive to the child's health and nutritional needs, caregiver responsiveness, and emotional support during early childhood, especially in the first two years of life-protects the child and their development from the damaging effects associated with poor socioeconomic conditions. Failing to provide such conditions and stimuli results in impaired full development of the child, with serious individual consequences such as chronic diseases in adulthood, lower academic achievement, and reduced labor market participation and income throughout adult life. On a societal level, the consequences include increased public health costs, the persistence and worsening of social inequality, and the loss of human capital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Months 至 22 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children enrolled in the social assistance vulnerability datasystem (CADUNico or Bolsa Família Recipient)

排除标准

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

结局指标

主要结局

Overall child development

时间窗: Age 2 - 3 years in after 12 months of intervention

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.

次要结局

  • Parenting practices(Assessment after 12 months of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Brentani

Associate professor

University of Sao Paulo

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