The Bucharest Early Intervention Project (BEIP)

• ClinicalTrials.gov Identifier: NCT00747396
• Recruitment Status: Active, not recruiting
• First Posted: September 5, 2008
• Last Update Posted: July 7, 2020
• Sponsor: Charles Alexander Nelson III
• 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); Vanderbilt University; Harvard University; University of North Carolina, Chapel Hill; University of Toronto
• Information provided by (Responsible Party): Charles Alexander Nelson III, Boston Children's Hospital

Study Description

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 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 Design

• 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 2025
• Estimated Study Completion Date: March 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Foster Care Placement 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 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
No Intervention: Care As Usual Group; Children randomized to this group remained in institutional care.

Outcome Measures

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, 21 years ]
   weight in kilograms
4. Changes in height [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]
   Height measured in centimeters
5. Changes in head circumference [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 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 Psychiatric Symptomatogology [ Time Frame: 21 years ]
   DIS + SAM
9. Changes in Expressive Language Quality [ Time Frame: 30 mos, 42 mos and 8 years ]
   language sample from interview
10. Changes in EEG Coherence Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]
    EEG coherence
11. Changes in EEG Power Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]
    EEG power
12. Changes in EEG Asymmetry Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]
    EEG asymmetry
13. 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
14. Changes in Attachment Style [ Time Frame: baseline, 30 mos and 42 mos ]
    Strange Situation Procedure
15. Changes in Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]
    Observational Record of Caregiving Environment
16. Changes in Indiscriminate Behavior [ Time Frame: 54 mos, 8 years and 12 years ]
    Stranger at the Door
17. Changes in Emotion Discrimination [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
    Event-related Potentials
18. Changes in Face Recognition [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
    Event-related Potentials
19. Changes in Brain Structure [ Time Frame: 8 years, 16 years, 21 years ]
    MRI
20. Changes in Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]
    Infant Toddler Social Emotional Assessment
21. Changes in Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
    Social Communication Questionnaire
22. 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

• Ages Eligible for Study: 21 Years to 22 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria for assessment at age 21 years:

• previously institutionalized and community children that took part in previous BEIP assessments
• target recruitment age is +/- 6 mos of 21st birthday

Exclusion Criteria for assessment at age 21 years:

• open or closed head injury within the past 12 months
• viral or bacterial meningitis within the past 12 months

Contacts and Locations

Locations

Romania

Fundatia Tanner

Bucharest, Romania, 011467

Sponsors and Collaborators

Charles Alexander Nelson III

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)

Vanderbilt University

Harvard University

University of North Carolina, Chapel Hill

University of Toronto

Investigators

• 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

More Information

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

Humphreys KL, Guyon-Harris KL, Tibu F, Wade M, Nelson CA, Fox NA, Zeanah CH. Psychiatric outcomes following severe deprivation in early childhood: Follow-up of a randomized controlled trial at age 16. J Consult Clin Psychol. 2020 Dec;88(12):1079-1090. doi: 10.1037/ccp0000613.

Humphreys KL, Machlin LS, Guyon-Harris KL, Nelson CA, Fox NA, Zeanah CH. Psychosocial deprivation and receptive language ability: a two-sample study. J Neurodev Disord. 2020 Dec 16;12(1):36. doi: 10.1186/s11689-020-09341-2.

Slopen N, Tang A, Nelson CA, Zeanah CH, McDade TW, McLaughlin KA, Fox NA. The Consequences of Foster Care Versus Institutional Care in Early Childhood on Adolescent Cardiometabolic and Immune Markers: Results From a Randomized Controlled Trial. Psychosom Med. 2019 Jun;81(5):449-457. doi: 10.1097/PSY.0000000000000696.

Wade M, Fox NA, Zeanah CH, Nelson CA, Drury SS. Telomere Length and Psychopathology: Specificity and Direction of Effects Within the Bucharest Early Intervention Project. J Am Acad Child Adolesc Psychiatry. 2020 Jan;59(1):140-148.e3. doi: 10.1016/j.jaac.2019.02.013. Epub 2019 Mar 4.

Wade M, Fox NA, Zeanah CH, Nelson CA. Effect of Foster Care Intervention on Trajectories of General and Specific Psychopathology Among Children With Histories of Institutional Rearing: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Nov 1;75(11):1137-1145. doi: 10.1001/jamapsychiatry.2018.2556. Erratum in: JAMA Psychiatry. 2019 Jan 1;76(1):102. JAMA Psychiatry. 2019 Apr 1;76(4):447. JAMA Psychiatry. 2019 Apr 1;76(4):447. JAMA Psychiatry. 2019 Apr 1;76(4):447.

Johnson DE, Tang A, Almas AN, Degnan KA, McLaughlin KA, Nelson CA, Fox NA, Zeanah CH, Drury SS. Caregiving Disruptions Affect Growth and Pubertal Development in Early Adolescence in Institutionalized and Fostered Romanian Children: A Randomized Clinical Trial. J Pediatr. 2018 Dec;203:345-353.e3. doi: 10.1016/j.jpeds.2018.07.027. Epub 2018 Aug 29.

Humphreys KL, Miron D, McLaughlin KA, Sheridan MA, Nelson CA, Fox NA, Zeanah CH. Foster care promotes adaptive functioning in early adolescence among children who experienced severe, early deprivation. J Child Psychol Psychiatry. 2018 Jul;59(7):811-821. doi: 10.1111/jcpp.12865. Epub 2018 Feb 1.

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
• Other Study ID Numbers: IRB-P00011741; R01MH091363 ( U.S. NIH Grant/Contract )
• First Posted: September 5, 2008
• Last Update Posted: July 7, 2020
• Last Verified: July 2020

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