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The Bucharest Early Intervention Project (BEIP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747396
First Posted: September 5, 2008
Last Update Posted: December 11, 2017
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.
Collaborators:
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)
Information provided by (Responsible Party):
Charles Alexander Nelson III, Boston Children's Hospital
  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 and/or Mood Disorders Brain Function Social Cognition Health Behavior Risk-Taking Executive Function Other: Foster Care Placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence

Further study details as provided by Charles Alexander Nelson III, Boston Children's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Changes in Physiological Reactivity to Stress [ Time Frame: 12 years, 16 years ]
    Trier Social Stress Test


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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
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

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, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00747396     History of Changes
Other Study ID Numbers: IRB-P00011741
R01MH091363 ( U.S. NIH Grant/Contract )
First Submitted: September 4, 2008
First Posted: September 5, 2008
Last Update Posted: December 11, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders