Clinical trial NCT00747396: The Bucharest Early Intervention Project
Official title: The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Tulane University Health Sciences Center
name: University of Maryland
name: University of Minnesota
name: Temple University
name: Duke University
name: MacArthur Foundation
name: National Institute of Mental Health (NIMH)
name: Vanderbilt University
name: Harvard University
name: University of North Carolina, Chapel Hill
name: University of Toronto
First posted: 2008-09-05
Enrollment: 136
Sex: ALL
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in EEG Coherence Brain Function
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
measure: Changes in EEG Power Brain Function
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
measure: Changes in EEG Asymmetry Brain Function
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
measure: Changes in Attachment Disturbances and Disorders
timeFrame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
measure: Changes in Attachment Style
timeFrame: baseline, 30 mos and 42 mos
measure: Changes in Cognition in later childhood and adolescence
timeFrame: 8 years, 12 years, 16-18 years
measure: Changes in Cognition in young adulthood
timeFrame: 21 years
measure: Changes in Cognition in early childhood
timeFrame: baseline, 30 months, 42 months
measure: Changes in weight
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
measure: Changes in height
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
measure: Changes in head circumference
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
measure: Changes in Psychiatric Symptomatology in adolescence
timeFrame: 12 years, 16 years
measure: Changes in Psychiatric Symptomatogology
timeFrame: 54 months, 8 years
measure: Changes in Psychiatric Symptomatogology
timeFrame: 21 years
measure: Changes in Expressive Language Quality
timeFrame: 30 mos, 42 mos and 8 years
measure: Changes in Caregiving Environment
timeFrame: baseline, 30 mos and 42 mos
measure: Changes in Indiscriminate Behavior
timeFrame: 54 mos, 8 years and 12 years
measure: Changes in Emotion Discrimination
timeFrame: baseline, 30 mos, 42 mos and 8 years
measure: Changes in Face Recognition
timeFrame: baseline, 30 mos, 42 mos and 8 years
measure: Changes in Brain Structure
timeFrame: 8 years, 16 years, 21 years
measure: Changes in Problem Behaviors
timeFrame: baseline, 30 mos and 42 mos
measure: Changes in Social Communication and Interaction
timeFrame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
measure: Changes in Genetics
timeFrame: 8 years, 12 years, 16 years
Secondary outcomes:
measure: Changes in Emotional Reactivity/Temperament
timeFrame: baseline, 30 mos and 42 mos
measure: Motor Skills
timeFrame: 8 years
Other outcomes:
measure: Changes in Physiological Reactivity to Stress
timeFrame: 12 years, 16 years
Locations:
city: Bucharest
country: Romania
facility: Fundatia Tanner
Study officials:
affiliation: Children's Hospital Boston/Harvard University
name: Charles A Nelson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Nathan A. Fox, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University Health Sciences Center
name: Charles H. Zeanah, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.