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The Bucharest Early Intervention Project

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747396
Acronym
BEIP
Enrollment
136
Registered
2008-09-05
Start date
2000-09-30
Completion date
2027-03-31
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERFoster 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.

Sponsors

Tulane University Health Sciences Center
CollaboratorOTHER
University of Maryland
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
Temple University
CollaboratorOTHER
Duke University
CollaboratorOTHER
MacArthur Foundation
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Vanderbilt University
CollaboratorOTHER
Harvard University
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Charles Alexander Nelson III
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Emotion Discriminationbaseline, 30 mos, 42 mos and 8 yearsEvent-related Potentials
Changes in Expressive Language Quality30 mos, 42 mos and 8 yearslanguage sample from interview
Changes in Caregiving Environmentbaseline, 30 mos and 42 mosObservational Record of Caregiving Environment
Changes in Indiscriminate Behavior54 mos, 8 years and 12 yearsStranger at the Door
Changes in Face Recognitionbaseline, 30 mos, 42 mos and 8 yearsEvent-related Potentials
Changes in Brain Structure8 years, 16 years, 21 yearsMRI
Changes in Problem Behaviorsbaseline, 30 mos and 42 mosInfant Toddler Social Emotional Assessment
Changes in Social Communication and Interactionbaseline, 30 mos, 42 mos, 8 years, 12 years, 16 yearsSocial Communication Questionnaire
Changes in Genetics8 years, 12 years, 16 yearsBuccal Swab
Changes in EEG Coherence Brain Functionbaseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 yearsEEG coherence
Changes in EEG Power Brain Functionbaseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 yearsEEG power
Changes in EEG Asymmetry Brain Functionbaseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 yearsEEG asymmetry
Changes in Attachment Disturbances and Disordersbaseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 yearsDisturbances of Attachment Interview
Changes in Attachment Stylebaseline, 30 mos and 42 mosStrange Situation Procedure
Changes in Cognition in later childhood and adolescence8 years, 12 years, 16-18 yearsWechsler Intelligence Scale for Children-IV
Changes in Cognition in young adulthood21 yearsWechsler Adult Intelligence Scale
Changes in Cognition in early childhoodbaseline, 30 months, 42 monthsBayley Scales of Infant Development
Changes in weightbaseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 yearsweight in kilograms
Changes in heightbaseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 yearsHeight measured in centimeters
Changes in head circumferencebaseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 yearsHead circumference in centimeters
Changes in Psychiatric Symptomatology in adolescence12 years, 16 yearsDiagnostic Interview Schedule for Children -IV
Changes in Psychiatric Symptomatogology54 months, 8 yearsPreschool And Child Adolescent Psychological Assessment

Secondary

MeasureTime frameDescription
Changes in Emotional Reactivity/Temperamentbaseline, 30 mos and 42 mosLaboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo
Motor Skills8 yearsBruininks-Oseretsky Test-2

Other

MeasureTime frameDescription
Changes in Physiological Reactivity to Stress12 years, 16 yearsTrier Social Stress Test

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026