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

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Charles Alexander Nelson III, Boston Children's Hospital

ClinicalTrials.gov Identifier:

NCT00747396

First received: September 4, 2008

Last updated: November 30, 2016

Last verified: November 2016

History of Changes

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:

Cognition [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years ]
Physical Growth (weight, height and head circumference) [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
Psychiatric Symptomatology [ Time Frame: 54 mos, 8 years, 12 years, 16 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, 8 years, 12 years, 16 years ]
Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years ]
Attachment Style [ Time Frame: baseline, 30 mos and 42 mos ]
Strange Situation Procedure
Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]
Indiscriminate Behavior [ Time Frame: 54 mos, 8 years and 12 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, 16 years ]
Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]
Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
Genetics [ Time Frame: 8 years, 12 years, 16 years ]

Secondary Outcome Measures:

Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ]
Motor Skills [ Time Frame: 8 years ]

Other Outcome Measures:

Physiological Reactivity to Stress [ Time Frame: 12 years, 16 years ]


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.

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:	16 Years to 17 Years (Child)
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

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

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):

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 )
Study First Received:	September 4, 2008
Last Updated:	November 30, 2016

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

ClinicalTrials.gov processed this record on September 19, 2017

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