The Bucharest Early Intervention Project (BEIP)

Charles Alexander Nelson III

Status: Active, not recruiting

Conditions: Brain Function; Psychiatric and/or Mood Disorders; Cognitive Ability, General; Health Behavior; Risk-Taking; Executive Function; Social Cognition

Treatments: Other: Foster Care Placement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00747396

IRB-P00011741

R01MH091363 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 beginning in the fall of 2000 from 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, 12 year and 16 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, now young adults are being assessed at age 21 years.

Enrollment: 136 patients

Sex: All

Ages: 21 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for assessment at age 21 years:

• previously institutionalized and community children that took part in previous BEIP assessments
• target recruitment age is +/- 6 mos of 21st birthday

Exclusion Criteria for assessment at age 21 years:

• open or closed head injury within the past 12 months
• viral or bacterial meningitis within the past 12 months

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Foster Care Placement Group

Experimental group

Description:

Children randomized to this group were placed in high quality foster care developed for the study.

Treatment:

Other: Foster Care Placement

Care As Usual Group

No Intervention group

Description:

Children randomized to this group remained in institutional care.