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

September 4, 2008
July 27, 2015
September 2000
March 2019   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00747396 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Physiological Reactivity to Stress [ Time Frame: 12 years ] [ Designated as safety issue: No ]
Not Provided
 
The Bucharest Early Intervention Project
The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence

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 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Cognitive Ability, General
  • Psychiatric &or Mood Disorder
  • Growth
  • Brain Function
  • Social Cognition
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.
  • Experimental: Foster Care Group
    Children randomized to this group were placed in high quality foster care developed for the study.
    Intervention: Other: Foster Care Placement
  • No Intervention: Care As Usual Group
    Children randomized to this group remained in institutional care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
136
March 2019
March 2019   (final data collection date for primary outcome measure)

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
Both
12 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00747396
IRB-P00011741, R01MH091363
Yes
Charles Alexander Nelson III, Children's Hospital, Boston
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
  • National Institute of Mental Health (NIMH)
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
Children's Hospital Boston
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP