RecruitingNot ApplicableNCT04165746

Early Institutionalization Intervention Impact Project


Sponsor

Boston Children's Hospital

Enrollment

220 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 24 Months

Plain Language Summary

Simplified for easier understanding

This study is part of a larger research project examining how early life institutionalization affects child development in Brazil. Specifically, it is testing a program designed to improve the quality of caregiving for very young children (under 24 months) who have recently entered the institutional care system — such as orphanages or foster care — in and around São Paulo. Early childhood is a critical window for brain development, and the quality of caregiving during this time has lifelong consequences. The intervention trains caregivers to provide more sensitive and responsive care, with the goal of improving infants' emotional, cognitive, and social development. Researchers will track children's development over time to see whether the intervention makes a measurable difference. You may be eligible if: - Your child is under 24 months old at the time of the baseline assessment - Your child is newly entering the institutional care system in or near São Paulo, Brazil - Your child was born weighing at least 2,500 grams (not small or large for gestational age) - The institution director or foster parent is the child's legal guardian at baseline You may NOT be eligible if: - Your child has a neurological or genetic condition that severely impairs typical development (e.g., cerebral palsy, Down syndrome, fetal alcohol syndrome) - Your child weighed less than 2,500 grams at birth Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFoster 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.

BEHAVIORALCaregiving 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.


Locations(1)

Instituto PENSI

São Paulo, São Paulo, Brazil

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NCT04165746


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