Impact of early intervention on child development in foster care vs. institutional care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Early Institutionalization Intervention Impact Project aims to evaluate the effects of enhanced institutional care compared to high-quality foster care on the development of young children placed in out-of-home care. A total of 220 children under 24 months old will be randomly assigned to either enhanced institutional care or enhanced foster care, with both groups receiving caregiving training. Assessments will be conducted at baseline and follow-up points at 12, 24, and 36 months to measure socioemotional development, cognitive abilities, and psychiatric symptoms. The study seeks to determine which care setting better supports healthy development in children facing institutionalization.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto PENSI
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Nathan A Fox, PhD — University of Maryland
• Study coordinator: Charles A Nelson, PhD
• Email: charles.nelson@childrens.harvard.edu
• Phone: 617-355-0401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.