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The Bucharest Early Intervention Project (BEIP)

Primary Purpose

Cognitive Ability, General, Psychiatric and/or Mood Disorders, Brain Function

Status
Active
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Foster Care Placement
Sponsored by
Charles Alexander Nelson III
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Ability, General focused on measuring Romania,, children,, foster care,, institutionalization,, brain function,, MRI,, attachment,, language,, growth,, Intelligence Quotient (IQ),, psychiatric symptomatology, early intervention

Eligibility Criteria

21 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundatia Tanner

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Foster Care Placement Group

Care As Usual Group

Arm Description

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

Children randomized to this group remained in institutional care.

Outcomes

Primary Outcome Measures

Changes in EEG Coherence Brain Function
EEG coherence
Changes in EEG Power Brain Function
EEG power
Changes in EEG Asymmetry Brain Function
EEG asymmetry
Changes in Attachment Disturbances and Disorders
Disturbances of Attachment Interview
Changes in Attachment Style
Strange Situation Procedure
Changes in Cognition in later childhood and adolescence
Wechsler Intelligence Scale for Children-IV
Changes in Cognition in young adulthood
Wechsler Adult Intelligence Scale
Changes in Cognition in early childhood
Bayley Scales of Infant Development
Changes in weight
weight in kilograms
Changes in height
Height measured in centimeters
Changes in head circumference
Head circumference in centimeters
Changes in Psychiatric Symptomatology in adolescence
Diagnostic Interview Schedule for Children -IV
Changes in Psychiatric Symptomatogology
Preschool And Child Adolescent Psychological Assessment
Changes in Psychiatric Symptomatogology
Diagnostic Interview Schedule + Substance Abuse Module
Changes in Expressive Language Quality
language sample from interview
Changes in Caregiving Environment
Observational Record of Caregiving Environment
Changes in Indiscriminate Behavior
Stranger at the Door
Changes in Emotion Discrimination
Event-related Potentials
Changes in Face Recognition
Event-related Potentials
Changes in Brain Structure
MRI
Changes in Problem Behaviors
Infant Toddler Social Emotional Assessment
Changes in Social Communication and Interaction
Social Communication Questionnaire
Changes in Genetics
Buccal Swab

Secondary Outcome Measures

Changes in Emotional Reactivity/Temperament
Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo
Motor Skills
Bruininks-Oseretsky Test-2

Full Information

First Posted
September 4, 2008
Last Updated
August 1, 2023
Sponsor
Charles Alexander Nelson III
Collaborators
Tulane University Health Sciences Center, University of Maryland, 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
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1. Study Identification

Unique Protocol Identification Number
NCT00747396
Brief Title
The Bucharest Early Intervention Project
Acronym
BEIP
Official Title
The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2000 (undefined)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Charles Alexander Nelson III
Collaborators
Tulane University Health Sciences Center, University of Maryland, 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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foster Care Placement Group
Arm Type
Experimental
Arm Description
Children randomized to this group were placed in high quality foster care developed for the study.
Arm Title
Care As Usual Group
Arm Type
No Intervention
Arm Description
Children randomized to this group remained in institutional care.
Intervention Type
Other
Intervention Name(s)
Foster Care Placement
Other Intervention Name(s)
Foster Care Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in EEG Coherence Brain Function
Description
EEG coherence
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Title
Changes in EEG Power Brain Function
Description
EEG power
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Title
Changes in EEG Asymmetry Brain Function
Description
EEG asymmetry
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Title
Changes in Attachment Disturbances and Disorders
Description
Disturbances of Attachment Interview
Time Frame
baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Title
Changes in Attachment Style
Description
Strange Situation Procedure
Time Frame
baseline, 30 mos and 42 mos
Title
Changes in Cognition in later childhood and adolescence
Description
Wechsler Intelligence Scale for Children-IV
Time Frame
8 years, 12 years, 16-18 years
Title
Changes in Cognition in young adulthood
Description
Wechsler Adult Intelligence Scale
Time Frame
21 years
Title
Changes in Cognition in early childhood
Description
Bayley Scales of Infant Development
Time Frame
baseline, 30 months, 42 months
Title
Changes in weight
Description
weight in kilograms
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Title
Changes in height
Description
Height measured in centimeters
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Title
Changes in head circumference
Description
Head circumference in centimeters
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Title
Changes in Psychiatric Symptomatology in adolescence
Description
Diagnostic Interview Schedule for Children -IV
Time Frame
12 years, 16 years
Title
Changes in Psychiatric Symptomatogology
Description
Preschool And Child Adolescent Psychological Assessment
Time Frame
54 months, 8 years
Title
Changes in Psychiatric Symptomatogology
Description
Diagnostic Interview Schedule + Substance Abuse Module
Time Frame
21 years
Title
Changes in Expressive Language Quality
Description
language sample from interview
Time Frame
30 mos, 42 mos and 8 years
Title
Changes in Caregiving Environment
Description
Observational Record of Caregiving Environment
Time Frame
baseline, 30 mos and 42 mos
Title
Changes in Indiscriminate Behavior
Description
Stranger at the Door
Time Frame
54 mos, 8 years and 12 years
Title
Changes in Emotion Discrimination
Description
Event-related Potentials
Time Frame
baseline, 30 mos, 42 mos and 8 years
Title
Changes in Face Recognition
Description
Event-related Potentials
Time Frame
baseline, 30 mos, 42 mos and 8 years
Title
Changes in Brain Structure
Description
MRI
Time Frame
8 years, 16 years, 21 years
Title
Changes in Problem Behaviors
Description
Infant Toddler Social Emotional Assessment
Time Frame
baseline, 30 mos and 42 mos
Title
Changes in Social Communication and Interaction
Description
Social Communication Questionnaire
Time Frame
baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Title
Changes in Genetics
Description
Buccal Swab
Time Frame
8 years, 12 years, 16 years
Secondary Outcome Measure Information:
Title
Changes in Emotional Reactivity/Temperament
Description
Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo
Time Frame
baseline, 30 mos and 42 mos
Title
Motor Skills
Description
Bruininks-Oseretsky Test-2
Time Frame
8 years
Other Pre-specified Outcome Measures:
Title
Changes in Physiological Reactivity to Stress
Description
Trier Social Stress Test
Time Frame
12 years, 16 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles A Nelson, Ph.D.
Organizational Affiliation
Children's Hospital Boston/Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathan A. Fox, Ph.D.
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles H. Zeanah, M.D.
Organizational Affiliation
Tulane University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundatia Tanner
City
Bucharest
ZIP/Postal Code
011467
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
33370132
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.
Results Reference
derived
PubMed Identifier
33327936
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.
Results Reference
derived
PubMed Identifier
31008902
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.
Results Reference
derived
PubMed Identifier
30844465
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.
Results Reference
derived
PubMed Identifier
30267045
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. 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.
Results Reference
derived
PubMed Identifier
30172435
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.
Results Reference
derived
PubMed Identifier
29389015
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.
Results Reference
derived
PubMed Identifier
26598472
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.
Results Reference
derived
PubMed Identifier
26303560
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.
Results Reference
derived
PubMed Identifier
25622303
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.
Results Reference
derived
PubMed Identifier
21334562
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.
Results Reference
derived
PubMed Identifier
20439790
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.
Results Reference
derived
PubMed Identifier
20368481
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.
Results Reference
derived

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The Bucharest Early Intervention Project

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