The Bucharest Early Intervention Project
- Conditions
- Cognitive Ability, GeneralSocial CognitionPsychiatric and/or Mood DisordersExecutive FunctionRisk-TakingBrain FunctionHealth Behavior
- Interventions
- Other: Foster Care Placement
- Registration Number
- NCT00747396
- Lead Sponsor
- Charles Alexander Nelson III
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 136
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Foster Care Placement Group Foster Care Placement Children randomized to this group were placed in high quality foster care developed for the study.
- Primary Outcome Measures
Name Time Method Changes in Caregiving Environment baseline, 30 mos and 42 mos Observational Record of Caregiving Environment
Changes in Brain Structure 8 years, 16 years, 21 years MRI
Changes in Cognition in young adulthood 21 years Wechsler Adult Intelligence Scale
Changes in Cognition in early childhood baseline, 30 months, 42 months Bayley Scales of Infant Development
Changes in Face Recognition baseline, 30 mos, 42 mos and 8 years Event-related Potentials
Changes in EEG Power Brain Function baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years EEG power
Changes in EEG Asymmetry Brain Function baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years EEG asymmetry
Changes in Attachment Disturbances and Disorders baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years Disturbances of Attachment Interview
Changes in Attachment Style baseline, 30 mos and 42 mos Strange Situation Procedure
Changes in weight baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years weight in kilograms
Changes in height baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years Height measured in centimeters
Changes in head circumference baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years Head circumference in centimeters
Changes in Genetics 8 years, 12 years, 16 years Buccal Swab
Changes in Cognition in later childhood and adolescence 8 years, 12 years, 16-18 years Wechsler Intelligence Scale for Children-IV
Changes in Psychiatric Symptomatology in adolescence 12 years, 16 years Diagnostic Interview Schedule for Children -IV
Changes in Expressive Language Quality 30 mos, 42 mos and 8 years language sample from interview
Changes in Emotion Discrimination baseline, 30 mos, 42 mos and 8 years Event-related Potentials
Changes in Social Communication and Interaction baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years Social Communication Questionnaire
Changes in EEG Coherence Brain Function baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years EEG coherence
Changes in Psychiatric Symptomatogology 21 years Diagnostic Interview Schedule + Substance Abuse Module
Changes in Indiscriminate Behavior 54 mos, 8 years and 12 years Stranger at the Door
Changes in Problem Behaviors baseline, 30 mos and 42 mos Infant Toddler Social Emotional Assessment
- Secondary Outcome Measures
Name Time Method Changes in Emotional Reactivity/Temperament baseline, 30 mos and 42 mos Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo
Motor Skills 8 years Bruininks-Oseretsky Test-2
Trial Locations
- Locations (1)
Fundatia Tanner
🇷🇴Bucharest, Romania