NCT04165746

Early Institutionalization Intervention Impact Project

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 24 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Foster Care	Upon entry into the Child Protection System, if the child is assigned to one of the districts participating in the RCT, the court will notify the study team. Children that have been randomly assigned to Foster Care will be placed in a foster home within 48 hours of referral to the Family Court/Child Protection System. Children and Foster Parents will receive biweekly visits from Social Workers. Children and Foster parents will also participate in the caregiving intervention described below. Children will remain in the placement until such time as the social workers, psychologists and Family Court Judge determine that one of the following outcomes is appropriate: reunification with biological family or adoption.
BEHAVIORAL	Caregiving Intervention	During AVI an intervenor meets with a caregiver (foster parent or caregiver at the institution) and child in the home environment. During each session, the intervenor videotapes the caregiver and child doing play-based activities. During that meeting, the intervenor reviews the videos with the caregiver and provides positive, constructive feedback to the caregiver. AVI is aimed at increasing sensitivity in parents/caregivers in order to encourage positive interactions. The guiding principles are to create a positive environment and to convey that the caregiver is the expert on their own child. The AVI methodology was selected to be used as a method of caregiving intervention with the study participants due to its demonstrated results in its use with children in contexts of social vulnerability, as well as families included in the child protection system. This will be the first time that AVI is being used in foster and institutional care in Brazil.

Timeline

• Start date: 2023-03-16
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2019-11-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Brazil