The Bucharest Early Intervention Project (BEIP)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cognitive Ability, General; Psychiatric and/or Mood Disorders; Brain Function; Social Cognition; Health Behavior; Risk-Taking; Executive Function	Other: Foster Care Placement	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	136 participants
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
Study Start Date :	September 2000
Estimated Primary Completion Date :	March 2019
Estimated Study Completion Date :	March 2019

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Changes in Cognition in later childhood and adolescence [ Time Frame: 8 years, 12 years, 16-18 years ]
   WISC-IV
2. Changes in Cognition in early childhood [ Time Frame: baseline, 30 months, 42 months ]
   Bayley Scales of Infant Development
3. Changes in weight [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
   weight in kilograms
4. Changes in height [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
   Height measured in centimeters
5. Changes in head circumference [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
   Head circumference in centimeters
6. Changes in Psychiatric Symptomatology in adolescence [ Time Frame: 12 years, 16 years ]
   DISC -IV
7. Changes in Psychiatric Symptomatogology [ Time Frame: 54 months, 8 years ]
   Preschool Are/Child Adolescent Psychological Assessment
8. Changes in Expressive Language Quality [ Time Frame: 30 mos, 42 mos and 8 years ]
   language sample from interview
9. Changes in EEG Coherence Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
   EEG coherence
10. Changes in EEG Power Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    EEG power
11. Changes in EEG Asymmetry Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    EEG asymmetry
12. 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
13. Changes in Attachment Style [ Time Frame: baseline, 30 mos and 42 mos ]
    Strange Situation Procedure
14. Changes in Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]
    Observational Record of Caregiving Environment
15. Changes in Indiscriminate Behavior [ Time Frame: 54 mos, 8 years and 12 years ]
    Stranger at the Door
16. Changes in Emotion Discrimination [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
    Event-related Potentials
17. Changes in Face Recognition [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
    Event-related Potentials
18. Changes in Brain Structure [ Time Frame: 8 years, 16 years ]
    MRI
19. Changes in Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]
    Infant Toddler Social Emotional Assessment
20. Changes in Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    Social Communication Questionnaire
21. Changes in Genetics [ Time Frame: 8 years, 12 years, 16 years ]
    Buccal Swab

Secondary Outcome Measures :

1. Changes in Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ]
   LAB-Tab Puppets and Peek-a-boo
2. Motor Skills [ Time Frame: 8 years ]
   Bruininks-Oseretsky Test-2

Other Outcome Measures:

1. Changes in Physiological Reactivity to Stress [ Time Frame: 12 years, 16 years ]
   Trier Social Stress Test

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Humphreys KL, McGoron L, Sheridan MA, McLaughlin KA, Fox NA, Nelson CA 3rd, Zeanah CH. High-Quality Foster Care Mitigates Callous-Unemotional Traits Following Early Deprivation in Boys: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):977-83. doi: 10.1016/j.jaac.2015.09.010. Epub 2015 Oct 9.

Humphreys KL, Gleason MM, Drury SS, Miron D, Nelson CA 3rd, Fox NA, Zeanah CH. Effects of institutional rearing and foster care on psychopathology at age 12 years in Romania: follow-up of an open, randomised controlled trial. Lancet Psychiatry. 2015 Jul;2(7):625-34. doi: 10.1016/S2215-0366(15)00095-4. Epub 2015 Jun 23.

Bick J, Zhu T, Stamoulis C, Fox NA, Zeanah C, Nelson CA. Effect of early institutionalization and foster care on long-term white matter development: a randomized clinical trial. JAMA Pediatr. 2015 Mar;169(3):211-9. doi: 10.1001/jamapediatrics.2014.3212.

Gleason MM, Fox NA, Drury S, Smyke A, Egger HL, Nelson CA 3rd, Gregas MC, Zeanah CH. Validity of evidence-derived criteria for reactive attachment disorder: indiscriminately social/disinhibited and emotionally withdrawn/inhibited types. J Am Acad Child Adolesc Psychiatry. 2011 Mar;50(3):216-231.e3. doi: 10.1016/j.jaac.2010.12.012. Epub 2011 Feb 1.

Bos KJ, Zeanah CH Jr, Smyke AT, Fox NA, Nelson CA 3rd. Stereotypies in children with a history of early institutional care. Arch Pediatr Adolesc Med. 2010 May;164(5):406-11. doi: 10.1001/archpediatrics.2010.47.

Johnson DE, Guthrie D, Smyke AT, Koga SF, Fox NA, Zeanah CH, Nelson CA 3rd. Growth and associations between auxology, caregiving environment, and cognition in socially deprived Romanian children randomized to foster vs ongoing institutional care. Arch Pediatr Adolesc Med. 2010 Jun;164(6):507-16. doi: 10.1001/archpediatrics.2010.56. Epub 2010 Apr 5.

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 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