The Bucharest Early Intervention Project

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Foster Care Placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foster Care Placement Group<br>Children randomized to this group were placed in high quality foster care developed for the study. | Other: Foster Care Placement<br>* 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.<br>* Other names: Foster Care Group;|
| No Intervention: Care As Usual Group<br>Children randomized to this group remained in institutional care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EEG Coherence Brain Function | EEG coherence | baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years | 
| Changes in EEG Power Brain Function | EEG power | baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years | 
| Changes in EEG Asymmetry Brain Function | EEG asymmetry | baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years | 
| Changes in Attachment Disturbances and Disorders | Disturbances of Attachment Interview | baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years | 
| Changes in Attachment Style | Strange Situation Procedure | baseline, 30 mos and 42 mos | 
| Changes in Cognition in later childhood and adolescence | Wechsler Intelligence Scale for Children-IV | 8 years, 12 years, 16-18 years | 
| Changes in Cognition in young adulthood | Wechsler Adult Intelligence Scale | 21 years | 
| Changes in Cognition in early childhood | Bayley Scales of Infant Development | baseline, 30 months, 42 months | 
| Changes in weight | weight in kilograms | baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years | 
| Changes in height | Height measured in centimeters | baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years | 
| Changes in head circumference | Head circumference in centimeters | 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 | 12 years, 16 years | 
| Changes in Psychiatric Symptomatogology | Preschool And Child Adolescent Psychological Assessment | 54 months, 8 years | 
| Changes in Psychiatric Symptomatogology | Diagnostic Interview Schedule + Substance Abuse Module | 21 years | 
| Changes in Expressive Language Quality | language sample from interview | 30 mos, 42 mos and 8 years | 
| Changes in Caregiving Environment | Observational Record of Caregiving Environment | baseline, 30 mos and 42 mos | 
| Changes in Indiscriminate Behavior | Stranger at the Door | 54 mos, 8 years and 12 years | 
| Changes in Emotion Discrimination | Event-related Potentials | baseline, 30 mos, 42 mos and 8 years | 
| Changes in Face Recognition | Event-related Potentials | baseline, 30 mos, 42 mos and 8 years | 
| Changes in Brain Structure | MRI | 8 years, 16 years, 21 years | 
| Changes in Problem Behaviors | Infant Toddler Social Emotional Assessment | baseline, 30 mos and 42 mos | 
| Changes in Social Communication and Interaction | Social Communication Questionnaire | baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years | 
| Changes in Genetics | Buccal Swab | 8 years, 12 years, 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Emotional Reactivity/Temperament | Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo | baseline, 30 mos and 42 mos | 
| Motor Skills | Bruininks-Oseretsky Test-2 | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Romania,, children,, foster care,, institutionalization,, brain function,, MRI,, attachment,, language,, growth,, Intelligence Quotient (IQ),, psychiatric symptomatology, early intervention