The Bucharest Early Intervention Project

N/AActive Not RecruitingNCT00747396

Charles Alexander Nelson III136 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

136

Conditions

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

Interventions

Foster Care PlacementOTHER

A group of children living in institutions in Bucharest, Romania was randomly assigned to placement in foster care. Foster parents were recruited, consented to background checks, and trained in Romanian. Before placement, foster parents visited their children to begin developing a relationship with the child. 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 occurring weekly for several months after placement of the child, then biweekly and later monthly. Foster parents were invited to participate in a support group organized by social workers. Project social workers consulted weekly with US staff experienced in dealing with young children in foster care.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 24 Years

Medical Language ↔ Plain English

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

Locations (1)

Fundatia Tanner

Bucharest, Romania

Outcomes

Primary Outcomes

Changes in EEG Coherence Brain Function

EEG coherence

Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

Changes in EEG Power Brain Function

EEG power

Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

Changes in EEG Asymmetry Brain Function

EEG asymmetry

Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

Changes in Attachment Disturbances and Disorders

Disturbances of Attachment Interview

Time frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years

Changes in Attachment Style

Strange Situation Procedure

Time frame: baseline, 30 mos and 42 mos

Changes in Cognition in later childhood and adolescence

Wechsler Intelligence Scale for Children-IV

Time frame: 8 years, 12 years, 16-18 years

Changes in Cognition in young adulthood

Wechsler Adult Intelligence Scale

Time frame: 21 years

Changes in Cognition in early childhood

Bayley Scales of Infant Development

Time frame: baseline, 30 months, 42 months

Changes in weight

weight in kilograms

Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

Data from ClinicalTrials.gov

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The Bucharest Early Intervention Project

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes