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Sponsors and Collaborators: |
Children's Hospital Boston MacArthur Foundation Tulane University Health Sciences Center University of Maryland University of Minnesota Temple University Duke University |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00747396 |
The purpose of this study is to determine the effect of early intervention (placement into foster care) on physical, cognitive, social and brain development and psychiatric symptomatology in previously institutionalized children.
Condition | Intervention |
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Cognition Psychiatric Symptomatology Growth Brain Function |
Other: foster care placement |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | The Bucharest Early Intervention Project |
Enrollment: | 136 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Foster Care Group (placement into foster care)
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Other: foster care placement
A group of children living in any of the six institutions for young, abandoned children in Bucharest, Romania was randomly assigned to placement in foster care. Foster parents were recruited and consented to background checks, received parent training in Romanian. Prior to placement, foster parents visited their children in the institution 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 wer also given the opportunity to take part 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.
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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 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, 42 and 54 months og 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 8 years.
Ages Eligible for Study: | 93 Months to 99 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for assessment at age 96 months:
Exclusion Criteria for assessment at age 96 months:
Romania | |
Fundatia Tulane | |
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: | Children's Hospital Boston/Harvard Medical School ( Charles A. Nelson III, Ph.D./Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience ) |
Study ID Numbers: | 06-86458-000-HCD |
Study First Received: | September 4, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00747396 |
Health Authority: | United States: Institutional Review Board |
Romania, children, foster care, institutionalization, brain function, MRI, |
attachment, language, growth, IQ, psychiatric symptomatology early intervention |