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Early Institutionalization Intervention Impact Project

Early Institutionalization Intervention Impact Project

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04165746
Acronym
EI-3
Enrollment
220
Registered
2019-11-18
Start date
2023-03-16
Completion date
2029-03-31
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Brazil, children, foster care, institutionalization, attachment, brain function, language, growth, Intelligence Quotient (IQ), early intervention

Brief 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.

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.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER
University of Maryland, College Park
CollaboratorOTHER
Tulane University
CollaboratorOTHER
Instituto PENSI
CollaboratorUNKNOWN
Harvard University
CollaboratorOTHER
Inter-American Development Bank
CollaboratorOTHER
Lumos Foundation
CollaboratorUNKNOWN
Two Lilies Fund
CollaboratorUNKNOWN
Fundaçao Maria Cecilia Souto Vidigal
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Children will be randomized to either enhanced institutional care or enhanced foster care. Both arms of the RCT will participate in an intervention. Children randomized to foster care will receive 2 forms of intervention.

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Differences in security of attachmentbaseline, 12 mos, 24 mos, 36 mosStrange Situation Procedure
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivitybaseline, 12 mos, 24 mos, 36 mosEEG power

Secondary

MeasureTime frameDescription
Differences in Cognition in early Childhoodbaseline, 12 mos, 24 mos, 36 mosMullen 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.
Differences in Attachment Disturbances and Disordersbaseline, 12 mos, 24 mos, 36 mosDisturbances of Attachment Interview
Differences in Competencebaseline, 12 mos, 24 mos, 36 mosInfant 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."

Countries

Brazil

Contacts

CONTACTCharles A Nelson, PhD
charles.nelson@childrens.harvard.edu617-355-0401
PRINCIPAL_INVESTIGATORNathan A Fox, PhD

University of Maryland

PRINCIPAL_INVESTIGATORCharles A Nelson, PhD

BOSTON CHILDRENS HOSPITAL/ Harvard University

PRINCIPAL_INVESTIGATORCharles H Zeanah, PhD

Tulane University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026