The Bucharest Early Intervention Project (BEIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Tulane University Health Sciences Center
University of Maryland
University of Minnesota - Clinical and Translational Science Institute
Temple University
Duke University
MacArthur Foundation
Information provided by (Responsible Party):
Charles Alexander Nelson III, Children's Hospital, Boston
ClinicalTrials.gov Identifier:
NCT00747396
First received: September 4, 2008
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Cognitive Ability, General
Psychiatric &or Mood Disorder
Growth
Brain Function
Social Cognition
Other: Foster Care Placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cognition [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years ] [ Designated as safety issue: No ]
  • Physical Growth (weight, height and head circumference) [ Time Frame: baseline, 30 mos, 42 mos, 8 years and 12 years ] [ Designated as safety issue: No ]
  • Psychiatric Symptomatology [ Time Frame: 54 mos, 8 years and 12 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, 8 years and 12 years ] [ Designated as safety issue: No ]
  • Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years and 12 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, 8 years and 12 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 and 12 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 ]

Other Outcome Measures:
  • Physiological Reactivity to Stress [ Time Frame: 12 years ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: September 2000
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Foster Care Group
Children randomized to this group were placed in high quality foster care developed for the study.
Other: 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: Care As Usual Group
Children randomized to this group remained in institutional 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 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.

  Eligibility

Ages Eligible for Study:   12 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for assessment at age 12 years:

  • previously institutionalized children that took part in previous BEIP assessments
  • within 3 mos of 12th birthday

Exclusion Criteria for assessment at age 12 years:

  • open or closed head injury within the past 12 months
  • viral or bacterial meningitis within the past 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747396

Locations
Romania
Fundatia Tanner
Bucharest, Romania, 011467
Sponsors and Collaborators
Charles Alexander Nelson III
Tulane University Health Sciences Center
University of Maryland
University of Minnesota - Clinical and Translational Science Institute
Temple University
Duke University
MacArthur Foundation
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 by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles Alexander Nelson III, Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00747396     History of Changes
Other Study ID Numbers: IRB-P00011741, R01MH091363
Study First Received: September 4, 2008
Last Updated: July 27, 2015
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

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 03, 2015