An interventional study of Foster Care Placement in Cognitive Ability, General, Psychiatric and/or Mood Disorders and Brain Function, sponsored by Charles Alexander Nelson III. Active, not recruiting at 1 site in Romania. Open to participants aged 21 Years to 24 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Charles Alexander Nelson III · Not applicable, Interventional, and Basic science
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.
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.
967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.
This study's enrollment of 136 is close to the median of 150 across 824 interventional studies indexed under Health Behavior.
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Exclusion Criteria for assessment at age 21 years:
Children randomized to this group were placed in high quality foster care developed for the study.
Other: Foster Care Placement
Children randomized to this group remained in institutional care.
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.
Also known as: Foster Care Group
Changes in EEG Coherence Brain Function
EEG coherence
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in EEG Power Brain Function
EEG power
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in EEG Asymmetry Brain Function
EEG asymmetry
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in Attachment Disturbances and Disorders
Disturbances of Attachment Interview
Time frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Changes in Attachment Style
Strange Situation Procedure
Time frame: baseline, 30 mos and 42 mos
Changes in Cognition in later childhood and adolescence
Wechsler Intelligence Scale for Children-IV
Time frame: 8 years, 12 years, 16-18 years
Changes in Cognition in young adulthood
Wechsler Adult Intelligence Scale
Time frame: 21 years
Changes in Cognition in early childhood
Bayley Scales of Infant Development
Time frame: baseline, 30 months, 42 months
Changes in weight
weight in kilograms
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in height
Height measured in centimeters
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in head circumference
Head circumference in centimeters
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in Psychiatric Symptomatology in adolescence
Diagnostic Interview Schedule for Children -IV
Time frame: 12 years, 16 years
Changes in Psychiatric Symptomatogology
Preschool And Child Adolescent Psychological Assessment
Time frame: 54 months, 8 years
Changes in Psychiatric Symptomatogology
Diagnostic Interview Schedule + Substance Abuse Module
Time frame: 21 years
Changes in Expressive Language Quality
language sample from interview
Time frame: 30 mos, 42 mos and 8 years
Changes in Caregiving Environment
Observational Record of Caregiving Environment
Time frame: baseline, 30 mos and 42 mos
Changes in Indiscriminate Behavior
Stranger at the Door
Time frame: 54 mos, 8 years and 12 years
Changes in Emotion Discrimination
Event-related Potentials
Time frame: baseline, 30 mos, 42 mos and 8 years
Changes in Face Recognition
Event-related Potentials
Time frame: baseline, 30 mos, 42 mos and 8 years
Changes in Brain Structure
MRI
Time frame: 8 years, 16 years, 21 years
Changes in Problem Behaviors
Infant Toddler Social Emotional Assessment
Time frame: baseline, 30 mos and 42 mos
Changes in Social Communication and Interaction
Social Communication Questionnaire
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Changes in Genetics
Buccal Swab
Time frame: 8 years, 12 years, 16 years
Changes in Emotional Reactivity/Temperament
Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo
Time frame: baseline, 30 mos and 42 mos
Motor Skills
Bruininks-Oseretsky Test-2
Time frame: 8 years
Changes in Physiological Reactivity to Stress
Trier Social Stress Test
Time frame: 12 years, 16 years
Started Sep 2000 (actual). Primary completion is estimated for Mar 2027, 318 months after the start.
Of 567 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 318 months is above that.
Counting every sponsor, half of 585 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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