The Bucharest Early Intervention Project (BEIP)
|Cognitive Ability, General Psychiatric and/or Mood Disorders Brain Function Social Cognition Health Behavior Risk-Taking Executive Function||Other: Foster Care Placement|
|Study Design:||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|
- Cognition [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years ]
- Physical Growth (weight, height and head circumference) [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
- Psychiatric Symptomatology [ Time Frame: 54 mos, 8 years, 12 years, 16 years ]
- Language [ Time Frame: 30 mos, 42 mos and 8 years ]
- Brain Function (EEG asymmetry, coherence and power) [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
- Attachment Disturbances and Disorders [ Time Frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years ]
- Attachment Style [ Time Frame: baseline, 30 mos and 42 mos ]Strange Situation Procedure
- Caregiving Environment [ Time Frame: baseline, 30 mos and 42 mos ]
- Indiscriminate Behavior [ Time Frame: 54 mos, 8 years and 12 years ]
- Emotion Discrimination (ERP) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
- Face Recognition (ERP) [ Time Frame: baseline, 30 mos, 42 mos and 8 years ]
- Brain Structure (MRI) [ Time Frame: 8 years, 16 years ]
- Problem Behaviors [ Time Frame: baseline, 30 mos and 42 mos ]
- Social Communication and Interaction [ Time Frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years ]
- Genetics [ Time Frame: 8 years, 12 years, 16 years ]
- Emotional Reactivity/Temperament [ Time Frame: baseline, 30 mos and 42 mos ]
- Motor Skills [ Time Frame: 8 years ]
- Physiological Reactivity to Stress [ Time Frame: 12 years, 16 years ]
|Study Start Date:||September 2000|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Experimental: Foster Care Group
Children randomized to this group were placed in high quality foster care developed for the study.
Other: Foster Care Placement
A group of children living in institutions for children in Bucharest, Romania was randomly assigned to placement in foster care. Foster parents were recruited, consented to background checks, and received training in Romanian. Prior to placement, foster parents visited their children to begin developing a relationship with the child. Once 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 occuring weekly for several months after initial placement of the child, then biweekly and later monthly. Foster parents also had the opportunity to participate in a support group organized by project social workers. Project social workers received weekly consultation from US staff experienced in dealing with young children in foster care.
No Intervention: Care As Usual Group
Children randomized to this group remained in institutional care.
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 from a feasibility phase in the fall of 2000, through 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 and 12 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 are currently being assessed at age 15-16 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747396
|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|