Impact of early intervention on child development in foster care vs. institutional care
Early Institutionalization Intervention Impact Project
This study is testing whether young children in foster care develop better than those in enhanced institutional care to see which option helps them grow up healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | N/A to 24 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT04165746 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 24 months old entering the institutional system in São Paulo, Brazil.
Not a fit: Children with severe neurological or genetic conditions that impair typical development will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved developmental outcomes for children in foster care compared to those in institutional settings.
How similar studies have performed: Other studies have shown promising results in improving child development outcomes through enhanced caregiving interventions, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.