The Bucharest Early Intervention Project

NCT00747396 | Active Not Recruiting DMC

• 2 other identifiers: IRB-P00011741R01MH091363
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Ability, General; Psychiatric and/or Mood Disorders; Brain Function; Social Cognition; Health Behavior; Risk-Taking; Executive Function

Keywords

Romania,; children,; foster care,; institutionalization,; brain function,; MRI,; attachment,; language,; growth,; Intelligence Quotient (IQ),; psychiatric symptomatology; early intervention

Outcome Measures

Primary Outcomes (23)

• Changes in EEG Coherence Brain Function

  EEG coherence

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

• Changes in EEG Power Brain Function

  EEG power

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

• Changes in EEG Asymmetry Brain Function

  EEG asymmetry

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

• Changes in Attachment Disturbances and Disorders

  Disturbances of Attachment Interview

  baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years

• Changes in Attachment Style

  Strange Situation Procedure

  baseline, 30 mos and 42 mos

• Changes in Cognition in later childhood and adolescence

  Wechsler Intelligence Scale for Children-IV

  8 years, 12 years, 16-18 years

• Changes in Cognition in young adulthood

  Wechsler Adult Intelligence Scale

  21 years

• Changes in Cognition in early childhood

  Bayley Scales of Infant Development

  baseline, 30 months, 42 months

• Changes in weight

  weight in kilograms

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

• Changes in height

  Height measured in centimeters

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

• Changes in head circumference

  Head circumference in centimeters

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

• Changes in Psychiatric Symptomatology in adolescence

  Diagnostic Interview Schedule for Children -IV

  12 years, 16 years

• Changes in Psychiatric Symptomatogology

  Preschool And Child Adolescent Psychological Assessment

  54 months, 8 years

• Changes in Psychiatric Symptomatogology

  Diagnostic Interview Schedule + Substance Abuse Module

  21 years

• Changes in Expressive Language Quality

  language sample from interview

  30 mos, 42 mos and 8 years

• Changes in Caregiving Environment

  Observational Record of Caregiving Environment

  baseline, 30 mos and 42 mos

• Changes in Indiscriminate Behavior

  Stranger at the Door

  54 mos, 8 years and 12 years

• Changes in Emotion Discrimination

  Event-related Potentials

  baseline, 30 mos, 42 mos and 8 years

• Changes in Face Recognition

  Event-related Potentials

  baseline, 30 mos, 42 mos and 8 years

• Changes in Brain Structure

  MRI

  8 years, 16 years, 21 years

• Changes in Problem Behaviors

  Infant Toddler Social Emotional Assessment

  baseline, 30 mos and 42 mos

• Changes in Social Communication and Interaction

  Social Communication Questionnaire

  baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years

• Changes in Genetics

  Buccal Swab

  8 years, 12 years, 16 years

Secondary Outcomes (2)

• Changes in Emotional Reactivity/Temperament

  baseline, 30 mos and 42 mos

• Motor Skills

  8 years

Other Outcomes (1)

• Changes in Physiological Reactivity to Stress

  12 years, 16 years

Study Arms (2)

Foster Care Placement Group

EXPERIMENTAL

Children randomized to this group were placed in high quality foster care developed for the study.

Other: Foster Care Placement

Care As Usual Group

NO INTERVENTION

Children randomized to this group remained in institutional care.

Interventions

Foster Care Placement OTHER

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.

Also known as: Foster Care Group

Foster Care Placement Group

Eligibility Criteria

• Age: 21 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charles Alexander Nelson III: lead
• Tulane University Health Sciences Center: collaborator
• University of Maryland: collaborator
• University of Minnesota: collaborator
• Temple University: collaborator
• Duke University: collaborator
• MacArthur Foundation: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Vanderbilt University: collaborator
• Harvard University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of Toronto: collaborator

Study Sites (1)

Fundatia Tanner

Bucharest, 011467, Romania

Location

Related Publications (16)

• Arnett AB, Antunez M, Zeanah C, Fox NA, Nelson CA. Physical and neurophysiological maturation associated with ADHD among previously institutionalized children: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Jul;66(7):967-979. doi: 10.1111/jcpp.14110. Epub 2025 Jan 11.

  PMID: 39797613 DERIVED

• Guyon-Harris KL, Plamondon A, Humphreys KL, Wade M, Gleason MM, Tibu F, Nelson CA, Fox NA, Zeanah CH. Structure of Psychopathology in Romanian Preschool-Aged Children in an Epidemiological and a High-Risk Sample. JAACAP Open. 2023 Nov;1(3):173-183. doi: 10.1016/j.jaacop.2023.06.004. Epub 2023 Jul 19.

  PMID: 38500494 DERIVED

• King LS, Guyon-Harris KL, Valadez EA, Radulescu A, Fox NA, Nelson CA, Zeanah CH, Humphreys KL. A Comprehensive Multilevel Analysis of the Bucharest Early Intervention Project: Causal Effects on Recovery From Early Severe Deprivation. Am J Psychiatry. 2023 Aug 1;180(8):573-583. doi: 10.1176/appi.ajp.20220672. Epub 2023 May 22.

  PMID: 37211832 DERIVED

• 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.

  PMID: 33370132 DERIVED

• 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.

  PMID: 33327936 DERIVED

• 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.

  PMID: 31008902 DERIVED

• 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.

  PMID: 30844465 DERIVED

• 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.

  PMID: 30267045 DERIVED

• 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.

  PMID: 30172435 DERIVED

• 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.

  PMID: 29389015 DERIVED

• 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.

  PMID: 26598472 DERIVED

• 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.

  PMID: 26303560 DERIVED

• 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.

  PMID: 25622303 DERIVED

• 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.

  PMID: 21334562 DERIVED

• 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.

  PMID: 20439790 DERIVED

• 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.

  PMID: 20368481 DERIVED

MeSH Terms

Conditions

Health Behavior; Risk-Taking; Language

Condition Hierarchy (Ancestors)

Behavior; Communication

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: September 1, 2000
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

RO (1)