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Early Institutionalization Intervention Impact Project

Early Institutionalization Intervention Impact Project

Recruiting
24 years and younger
All
Phase N/A

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Overview

The purpose of this study is to determine the effects of early intervention (placement into foster care, and a caregiving training) on physical, cognitive, social and brain development and psychiatric symptomatology in children place in out-of-home care.

Description

The Early Institutionalization Intervention Impact (EI-3) Project will document and compare the impact of enhanced institutional care on early childhood development to that of high-quality foster care. We will recruit a large (n= 220) samples of young children who have been identified as having to be removed from their families and we will randomize these children to two groups: enhanced institutional care (Group 1) or to enhanced foster care (Group 2). Institutional caregivers and Foster Parents will participate in a caregiving training, along with the child, that includes 8-1.5 hour sessions over 8-9 weeks.

In this Randomized Control Trial (RCT), we will assess the children in Groups 1 and 2 at the time they come into care and then at several follow-up time points (12 months, 24 months, 36 months of age). We hypothesize that children placed into foster/family care (FCG) will display enhanced socioemotional development, and enhanced behavioral and neural patterns of attention, cognition and social cognition, compared to children placed in enhanced institutional care.

Eligibility

Inclusion Criteria:

  • newly entering the institution system in and near São Paulo, Brazil, and the institution director or foster parent is the guardian at the time of baseline,
  • at the time of baseline assessment the child is less than 24 months old,
  • the child's birth weight must be at or above 2500 grams; none should be small or large for dates.

Exclusion Criteria:

  • the child does not have a neurological or other genetic condition that severely impairs typical development (e.g. Cerebral Palsy, Fetal Alcohol Syndrome, Down Syndrome)
  • the child is below 2500 grams.

Study details
    Socioemotional Development
    Cognitive Ability
    Behavioral and Neural Patterns of Attention
    Brain Function
    Psychopathology

NCT04165746

Boston Children's Hospital

15 May 2026

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