The Bucharest Early Intervention Project (BEIP)
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ClinicalTrials.gov Identifier: NCT00747396 |
Recruitment Status :
Active, not recruiting
First Posted : September 5, 2008
Last Update Posted : August 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cognitive Ability, General Psychiatric and/or Mood Disorders Brain Function Social Cognition Health Behavior Risk-Taking Executive Function | Other: Foster Care Placement | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 136 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence |
Study Start Date : | September 2000 |
Estimated Primary Completion Date : | March 2025 |
Estimated Study Completion Date : | March 2025 |
Arm | Intervention/treatment |
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Experimental: Foster Care Placement Group
Children randomized to this group were placed in high quality foster care developed for the study.
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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 Name: Foster Care Group |
No Intervention: Care As Usual Group
Children randomized to this group remained in institutional care.
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- Changes in EEG Coherence Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]EEG coherence
- Changes in EEG Power Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]EEG power
- Changes in EEG Asymmetry Brain Function [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]EEG asymmetry
- Changes in Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years ]Disturbances of Attachment Interview
- Changes in Attachment Style [ Time Frame: baseline, 30 mos and 42 mos ]Strange Situation Procedure
- Changes in Cognition in later childhood and adolescence [ Time Frame: 8 years, 12 years, 16-18 years ]WISC-IV
- Changes in Cognition in young adulthood [ Time Frame: 21 years ]WAIS
- Changes in Cognition in early childhood [ Time Frame: baseline, 30 months, 42 months ]Bayley Scales of Infant Development
- Changes in weight [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]weight in kilograms
- Changes in height [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]Height measured in centimeters
- Changes in head circumference [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years ]Head circumference in centimeters
- Changes in Psychiatric Symptomatology in adolescence [ Time Frame: 12 years, 16 years ]DISC -IV
- Changes in Psychiatric Symptomatogology [ Time Frame: 54 months, 8 years ]Preschool Are/Child Adolescent Psychological Assessment
- Changes in Psychiatric Symptomatogology [ Time Frame: 21 years ]DIS + SAM
- Changes in Expressive Language Quality [ Time Frame: 30 mos, 42 mos and 8 years ]language sample from interview
- Changes in Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]Observational Record of Caregiving Environment
- Changes in Indiscriminate Behavior [ Time Frame: 54 mos, 8 years and 12 years ]Stranger at the Door
- Changes in Emotion Discrimination [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]Event-related Potentials
- Changes in Face Recognition [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]Event-related Potentials
- Changes in Brain Structure [ Time Frame: 8 years, 16 years, 21 years ]MRI
- Changes in Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]Infant Toddler Social Emotional Assessment
- Changes in Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]Social Communication Questionnaire
- Changes in Genetics [ Time Frame: 8 years, 12 years, 16 years ]Buccal Swab
- Changes in Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ]LAB-Tab Puppets and Peek-a-boo
- Motor Skills [ Time Frame: 8 years ]Bruininks-Oseretsky Test-2
- Changes in Physiological Reactivity to Stress [ Time Frame: 12 years, 16 years ]Trier Social Stress Test

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Ages Eligible for Study: | 21 Years to 22 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747396
Romania | |
Fundatia Tanner | |
Bucharest, Romania, 011467 |
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 |
Responsible Party: | Charles Alexander Nelson III, Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00747396 |
Other Study ID Numbers: |
IRB-P00011741 R01MH091363 ( U.S. NIH Grant/Contract ) |
First Posted: | September 5, 2008 Key Record Dates |
Last Update Posted: | August 9, 2022 |
Last Verified: | August 2022 |
Romania, children, foster care, institutionalization, brain function, MRI, |
attachment, language, growth, IQ, psychiatric symptomatology early intervention |
Mood Disorders Mental Disorders |