Actively Recruiting

Phase Not Applicable
Age: 0 - 24Months
All Genders
Healthy Volunteers
ID04165746

Early Institutionalization Intervention Impact Project for Young Children in Out-of-Home Care

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

220

Participants Needed

1

Research Sites

52 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

Researchers are studying the effects of early intervention on children placed in out-of-home care, focusing on their physical, cognitive, social, and brain development as well as psychiatric symptoms. This randomized control trial compares enhanced institutional care with high-quality foster care for young children removed from their families. The goal is to understand how these different care environments influence socioemotional development and behavioral and neural patterns of attention, cognition, and social cognition. Two groups of children will be studied: one group will receive enhanced institutional care where caregivers undergo a training called Attachment Video Feedback Intervention (AVI), involving 8 sessions over 8-9 weeks focused on positive interactions. The other group will be placed in foster care with foster parents who also receive training and support, including the VIPP caregiving training with 5 sessions over 6-8 weeks, and regular visits from social workers to monitor and support the placement. Participants will be assessed at baseline when entering care and followed up at 12, 24, and 36 months of age. Researchers will measure attachment security, brain activity through Alpha EEG power and connectivity, cognition, attachment disturbances, and competence. These evaluations include observing interactions, behavioral assessments, and neurophysiological measures to track development and psychiatric symptoms over time during the child's placement in care.

CONDITIONS

Brief Title

Early Institutionalization Intervention Impact Project

Who Can Participate

Age: 0 - 24Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly entering the institution system in and near São Paulo, Brazil, with the institution director or foster parent as guardian at baseline
  • Child is less than 24 months old at baseline assessment
  • Child's birth weight is at or above 2500 grams, not small or large for dates
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 weighs less than 2500 grams at birth

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Caregiving Intervention

Duration - 6 to 9 weeks

Participants and their caregivers participate in caregiving training sessions aimed at improving positive interactions. Institutional caregivers attend 8 sessions of 1.5 hours over 8 to 9 weeks. Foster parents attend 5 sessions of 2 hours over 6 to 8 weeks.

8 sessions for institutional caregivers and 5 sessions for foster parents conducted in the home environment

Treatment

Duration - Until reunification, adoption, or study end

Participants are placed in either enhanced institutional care or enhanced foster care. Foster parents receive visits from social workers weekly for several months after placement, then biweekly and later monthly. Institutional caregivers also participate in the caregiving intervention described above.

Weekly, biweekly, and monthly visits from social workers depending on time since placement

Follow-up Assessments

Duration - Up to 36 months from baseline

Participants undergo developmental assessments at baseline, 12 months, 24 months, and 36 months of age to measure socioemotional development, cognition, attachment, and neural patterns.

4 assessment visits at baseline, 12 months, 24 months, and 36 months

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

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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