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NCT Number: NCT04165746

Early Institutionalization Intervention Impact Project

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.

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Key information

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto PENSI

São Paulo, 01228-200, Brazil

Location status: Recruiting

Location contact

Edson Amaro, MD, PhD

CONTACT

[email protected]

+55 11 2155-9358

Edson Amaro, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foster Care

Other

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.

Caregiving Intervention

Behavioral

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.

Other names: Attachment Video Feedback intervention

Primary outcomes

  1. Differences in security of attachment

    Time frame: baseline, 12 mos, 24 mos, 36 mos

    Strange Situation Procedure

  2. Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity

    Time frame: baseline, 12 mos, 24 mos, 36 mos

    EEG power

Secondary outcomes

  1. Differences in Cognition in early Childhood

    Time frame: baseline, 12 mos, 24 mos, 36 mos

    Mullen Scales of Early Learning, AGS Edition. For the subscales (Visual Receptions, Fine Motor, Gross Motor, Receptive, and Expressive Language), the minimum T-score is 20 and the maximum is 80. A higher score indicates a better outcome. The Composite Standard Score goes from 49 to 155; 155 is the best outcome.

  2. Differences in Attachment Disturbances and Disorders

    Time frame: baseline, 12 mos, 24 mos, 36 mos

    Disturbances of Attachment Interview

  3. Differences in Competence

    Time frame: baseline, 12 mos, 24 mos, 36 mos

    Infant Toddler Social Emotional Assessments- Revised. Range for competence is 0-66. Ratings are 0, 1, 2 on 33 items. Higher scores are better outcomes. T-scores of 35 or lower on the Competence scale are also termed "of concern."

Study contacts

Contact information is provided by the study sponsor or research team.

Charles A Nelson, PhD

CONTACT

[email protected]

617-355-0401

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Fundação Maria Cecilia Souto Vidigal
  • Harvard University
  • Instituto PENSI
  • Inter-American Development Bank
  • Lumos Foundation
  • Tulane University
  • Two Lilies Fund
  • University of Maryland, College Park

Registry information

Acronym: EI-3

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Nov 18, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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