Overview

This trial is active, not recruiting.

Conditions cognitive ability, general, psychiatric and/or mood disorders, brain function, social cognition, health behavior, risk-taking, executive function
Treatment foster care placement
Sponsor Charles Alexander Nelson III
Collaborator Tulane University Health Sciences Center
Start date September 2000
End date March 2019
Trial size 136 participants
Trial identifier NCT00747396, IRB-P00011741, R01MH091363

Summary

The purpose of this study is to determine the long term effects of early intervention (placement into foster care) on physical, cognitive, social and brain development and psychiatric symptomatology in previously institutionalized children.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Children randomized to this group were placed in high quality foster care developed for the study.
foster care placement
A group of children living in institutions for children in Bucharest, Romania was randomly assigned to placement in foster care. Foster parents were recruited, consented to background checks, and received training in Romanian. Prior to placement, foster parents visited their children to begin developing a relationship with the child. Once hired, foster parents were supported and monitored by project social workers. Foster parents in the BEIP network received frequent visits from the social workers, with visits occuring weekly for several months after initial placement of the child, then biweekly and later monthly. Foster parents also had the opportunity to participate in a support group organized by project social workers. Project social workers received weekly consultation from US staff experienced in dealing with young children in foster care.
(No Intervention)
Children randomized to this group remained in institutional care.

Primary Outcomes

Measure
Cognition
time frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Physical Growth (weight, height and head circumference)
time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Psychiatric Symptomatology
time frame: 54 mos, 8 years, 12 years, 16 years
Language
time frame: 30 mos, 42 mos and 8 years
Brain Function (EEG asymmetry, coherence and power)
time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Attachment Disturbances and Disorders
time frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Attachment Style
time frame: baseline, 30 mos and 42 mos
Caregiving Environment
time frame: baseline, 30 mos and 42 mos
Indiscriminate Behavior
time frame: 54 mos, 8 years and 12 years
Emotion Discrimination (ERP)
time frame: baseline, 30 mos, 42 mos and 8 years
Face Recognition (ERP)
time frame: baseline, 30 mos, 42 mos and 8 years
Brain Structure (MRI)
time frame: 8 years, 16 years
Problem Behaviors
time frame: baseline, 30 mos and 42 mos
Social Communication and Interaction
time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Genetics
time frame: 8 years, 12 years, 16 years

Secondary Outcomes

Measure
Emotional Reactivity/Temperament
time frame: baseline, 30 mos and 42 mos
Motor Skills
time frame: 8 years

Eligibility Criteria

Male or female participants from 16 years up to 17 years old.

Inclusion Criteria for assessment at age 16 years: - previously institutionalized and community children that took part in previous BEIP assessments - target recruitment age is +/- 3 mos of 16th birthday Exclusion Criteria for assessment at age 16 years: - open or closed head injury within the past 12 months - viral or bacterial meningitis within the past 12 months

Additional Information

Official title The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
Principal investigator Charles A Nelson, Ph.D.
Description The Bucharest Early Intervention Project (BEIP) was a randomized controlled trial of foster care as an intervention for children abandoned at or around the time of birth and placed in one of six institutions for young children in Bucharest, Romania (Zeanah et al., 2003). The PI (Nelson) and Co-PIs (Zeanah and Fox) conducted this study from a feasibility phase in the fall of 2000, through baseline assessments and implementation of the intervention in the spring of 2001. The BEIP began with comprehensive assessments of 136 institutionalized children and their caregiving environments prior to randomization. Half the children were randomly assigned to high-quality foster care and the other half to remain in institutional care. The average age at foster care placement was 22 months (range=6-31 months). All children were initially seen prior to randomization and again for follow-up assessments at 30 months, 42 months 54 months, 8 years and 12 years of age. The development of children in foster care was compared to the development of children in institutions and to a group of never institutionalized children (community controls). These children are currently being assessed at age 15-16 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Boston Children’s Hospital.