The Bucharest Early Intervention Project (BEIP)

The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Executive Function; Health Behavior; Cognitive Ability, General; Risk-Taking; Social Cognition; Psychiatric and/or Mood Disorders; Brain Function
• Intervention / Treatment: Other: Foster Care Placement

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, 12 year and 16 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, now young adults are being assessed at age 21 years.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 011467
    • Fundatia Tanner

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Foster Care Group
No Intervention: Care As Usual Group; Children randomized to this group remained in institutional care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
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 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Skills	Bruininks-Oseretsky Test-2	8 years
Changes in Emotional Reactivity/Temperament	Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo	baseline, 30 mos and 42 mos

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Physiological Reactivity to Stress	Trier Social Stress Test	12 years, 16 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 4, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (Estimated): September 5, 2008

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MRI,; early intervention; children,; Romania,; foster care,; institutionalization,; brain function,; attachment,; language,; growth,; psychiatric symptomatology; Intelligence Quotient (IQ),
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: IRB-P00011741; R01MH091363 (U.S. NIH Grant/Contract)