Early Institutionalization Intervention Impact Project

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• University of Maryland, College Park

  collaborator OTHER

• Tulane University

  collaborator OTHER

• Instituto PENSI

  collaborator UNKNOWN

• Harvard University

  collaborator OTHER

• Inter-American Development Bank

  collaborator OTHER

• Lumos Foundation

  collaborator UNKNOWN

• Two Lilies Fund

  collaborator UNKNOWN

• Fundaçao Maria Cecilia Souto Vidigal

  collaborator UNKNOWN

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Nathan A Fox, PhD · University of Maryland

• Charles A Nelson, PhD · BOSTON CHILDRENS HOSPITAL/ Harvard University

• Charles H Zeanah, PhD · Tulane University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

24 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-16

Primary Completion

2028-03-31

Completion

2029-03-31

Countries

• Brazil

Study Locations