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The Bucharest Early Intervention Project (BEIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00747396
Recruitment Status : Active, not recruiting
First Posted : September 5, 2008
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
Tulane University Health Sciences Center
University of Maryland, College Park
University of Minnesota
Temple University
Duke University
MacArthur Foundation
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Charles Alexander Nelson III, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date June 4, 2019
Study Start Date  ICMJE September 2000
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Changes in Cognition in later childhood and adolescence [ Time Frame: 8 years, 12 years, 16-18 years ]
    WISC-IV
  • Changes in Cognition in early childhood [ Time Frame: baseline, 30 months, 42 months ]
    Bayley Scales of Infant Development
  • Changes in weight [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    weight in kilograms
  • Changes in height [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    Height measured in centimeters
  • Changes in head circumference [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    Head circumference in centimeters
  • Changes in Psychiatric Symptomatology in adolescence [ Time Frame: 12 years, 16 years ]
    DISC -IV
  • Changes in Psychiatric Symptomatogology [ Time Frame: 54 months, 8 years ]
    Preschool Are/Child Adolescent Psychological Assessment
  • Changes in Expressive Language Quality [ Time Frame: 30 mos, 42 mos and 8 years ]
    language sample from interview
  • Changes in EEG Coherence Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    EEG coherence
  • Changes in EEG Power Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    EEG power
  • Changes in EEG Asymmetry Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    EEG asymmetry
  • Changes in Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years ]
    Disturbances of Attachment Interview
  • Changes in Attachment Style [ Time Frame: baseline, 30 mos and 42 mos ]
    Strange Situation Procedure
  • Changes in Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]
    Observational Record of Caregiving Environment
  • Changes in Indiscriminate Behavior [ Time Frame: 54 mos, 8 years and 12 years ]
    Stranger at the Door
  • Changes in Emotion Discrimination [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
    Event-related Potentials
  • Changes in Face Recognition [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
    Event-related Potentials
  • Changes in Brain Structure [ Time Frame: 8 years, 16 years ]
    MRI
  • Changes in Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]
    Infant Toddler Social Emotional Assessment
  • Changes in Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    Social Communication Questionnaire
  • Changes in Genetics [ Time Frame: 8 years, 12 years, 16 years ]
    Buccal Swab
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • Cognition [ Time Frame: baseline, 30 mos, 42 mos, 54 mos and 8 years ]
  • Physical Growth (weight, height and head circumference) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
  • Psychiatric Symptomatology [ Time Frame: 54 mos and 8 years ]
  • Language [ Time Frame: 30 mos, 42 mos and 8 years ]
  • Brain Function (EEG asymmetry, coherence and power) [ Time Frame: baseline, 30 mos, 42 mos, and 8 years ]
  • Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos and 8 years ]
  • Attachment Style (Strange Situation Procedure) [ Time Frame: baseline, 30 mos and 42 mos ]
  • Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]
  • Indiscriminate Behavior [ Time Frame: 54 mos and 8 years ]
  • Emotion Discrimination (ERP) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
  • Face Recognition (ERP) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
  • Brain Structure (MRI) [ Time Frame: 8 years ]
  • Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]
  • Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
  • Genetics [ Time Frame: 8 years ]
Change History Complete list of historical versions of study NCT00747396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Changes in Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ]
    LAB-Tab Puppets and Peek-a-boo
  • Motor Skills [ Time Frame: 8 years ]
    Bruininks-Oseretsky Test-2
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ]
  • Motor Skills [ Time Frame: 8 years ]
Current Other Pre-specified Outcome Measures
 (submitted: December 7, 2017)
Changes in Physiological Reactivity to Stress [ Time Frame: 12 years, 16 years ]
Trier Social Stress Test
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Bucharest Early Intervention Project
Official Title  ICMJE The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
Brief Summary 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.
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 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 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 being assessed at age 16 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Cognitive Ability, General
  • Psychiatric and/or Mood Disorders
  • Brain Function
  • Social Cognition
  • Health Behavior
  • Risk-Taking
  • Executive Function
Intervention  ICMJE Other: Foster Care Placement
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.
Other Name: Foster Care Group
Study Arms  ICMJE
  • Experimental: Foster Care Placement 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 4, 2008)
136
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for assessment at age 16 years:

  • previously institutionalized and community children that took part in previous BEIP assessments
  • target recruitment age is +/- 3 mos of 16th birthday

Exclusion Criteria for assessment at age 16 years:

  • open or closed head injury within the past 12 months
  • viral or bacterial meningitis within the past 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747396
Other Study ID Numbers  ICMJE IRB-P00011741
R01MH091363 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Alexander Nelson III, Boston Children’s Hospital
Study Sponsor  ICMJE Charles Alexander Nelson III
Collaborators  ICMJE
  • Tulane University Health Sciences Center
  • University of Maryland, College Park
  • University of Minnesota
  • Temple University
  • Duke University
  • MacArthur Foundation
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Charles A Nelson, Ph.D. Children's Hospital Boston/Harvard University
Principal Investigator: Nathan A. Fox, Ph.D. University of Maryland, College Park
Principal Investigator: Charles H. Zeanah, M.D. Tulane University Health Sciences Center
PRS Account Boston Children’s Hospital
Verification Date June 2019

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