Clinic Trials

The Bucharest Early Intervention Project (BEIP)
This study is ongoing, but not recruiting participants.
First Received: September 4, 2008   Last Updated: September 11, 2008   History of Changes
Sponsors and Collaborators: Children's Hospital Boston
MacArthur Foundation
Tulane University Health Sciences Center
University of Maryland
University of Minnesota
Temple University
Duke University
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00747396

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

Condition Intervention
Cognition
Psychiatric Symptomatology
Growth
Brain FunctionOther: foster care placement

U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Parallel Assignment
Official Title:The Bucharest Early Intervention Project

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
Cognition [ Time Frame: baseline, 30 mos, 42 mos, 54 mos and 8 years ] [ Designated as safety issue: No ]
Physical Growth (weight, height and head circumference) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ] [ Designated as safety issue: No ]
Psychiatric Symptomatology [ Time Frame: 54 mos and 8 years ] [ Designated as safety issue: No ]
Language [ Time Frame: 30 mos, 42 mos and 8 years ] [ Designated as safety issue: No ]
Brain Function (EEG asymmetry, coherence and power) [ Time Frame: baseline, 30 mos, 42 mos, and 8 years ] [ Designated as safety issue: No ]
Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos and 8 years ] [ Designated as safety issue: No ]
Attachment Style (Strange Situation Procedure) [ Time Frame: baseline, 30 mos and 42 mos ] [ Designated as safety issue: No ]
Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ] [ Designated as safety issue: No ]
Indiscriminate Behavior [ Time Frame: 54 mos and 8 years ] [ Designated as safety issue: No ]
Emotion Discrimination (ERP) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ] [ Designated as safety issue: No ]
Face Recognition (ERP) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ] [ Designated as safety issue: No ]
Brain Structure (MRI) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ] [ Designated as safety issue: No ]
Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos and 8 years ] [ Designated as safety issue: No ]
Genetics [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ] [ Designated as safety issue: No ]
Motor Skills [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment:136
Study Start Date:September 2000
Estimated Study Completion Date:May 2009
Estimated Primary Completion Date:May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Foster Care Group (placement into foster care) Other: foster care placement
A group of children living in any of the six institutions for young, abandoned children in Bucharest, Romania was randomly assigned to placement in foster care. Foster parents were recruited and consented to background checks, received parent training in Romanian. Prior to placement, foster parents visited their children in the institution 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 wer also given the opportunity to take part 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.

Detailed 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, 42 and 54 months og 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 8 years.
  Eligibility
Ages Eligible for Study:   93 Months to 99 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
Inclusion Criteria for assessment at age 96 months:
previously institutionalized children that took part in previous BEIP assessments
within 3 mos of 8th birthday
Exclusion Criteria for assessment at age 96 months:
open or closed head injury within the past 12 months
viral or bacterial meningitis within the past 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747396

Locations
Romania
Fundatia Tulane
Bucharest, Romania, 011467

Sponsors and Collaborators
Children's Hospital Boston
MacArthur Foundation
Tulane University Health Sciences Center
University of Maryland
University of Minnesota
Temple University
Duke University
Investigators
Principal Investigator:Charles A Nelson, Ph.D.Children's Hospital Boston/Harvard University
Principal Investigator:Nathan A. Fox, Ph.D.University of Maryland
Principal Investigator:Charles H. Zeanah, M.D.Tulane University Health Sciences Center

  More Information

No publications provided
Responsible Party:Children's Hospital Boston/Harvard Medical School ( Charles A. Nelson III, Ph.D./Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience )
Study ID Numbers:06-86458-000-HCD
Study First Received:September 4, 2008
Last Updated:September 11, 2008
ClinicalTrials.gov Identifier:NCT00747396     History of Changes
Health Authority:United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Romania,
children,
foster care,
institutionalization,
brain function,
MRI,attachment,
language,
growth,
IQ,
psychiatric symptomatology
early intervention

ClinicalTrials.gov processed this record on April 24, 2009