Actively Recruiting

Phase Not Applicable
Age: 0 - 24Months
All Genders
Healthy Volunteers
NCT04165746

Early Institutionalization Intervention Impact Project

Led by Boston Children's Hospital · Updated on 2026-03-18

220

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

U

University of Maryland, College Park

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Early Institutionalization Intervention Impact Project

Who Can Participate

Age: 0 - 24Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is newly entering the institutional care system in or near São Paulo, Brazil
  • Child's guardian at baseline is the institution director or foster parent
  • Child is less than 24 months old at baseline assessment
  • Child's birth weight is at or above 2500 grams
  • No children who are small or large for gestational dates are included
Not Eligible

You will not qualify if you...

  • Child has a neurological or genetic condition severely impairing typical development (e.g., Cerebral Palsy, Fetal Alcohol Syndrome, Down Syndrome)
  • Child's birth weight is below 2500 grams

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto PENSI

São Paulo, São Paulo, Brazil, 01228-200

Actively Recruiting

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Research Team

C

Charles A Nelson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Early Institutionalization Intervention Impact Project | DecenTrialz