Trials / Active Not Recruiting
Active Not RecruitingNCT00747396
The Bucharest Early Intervention Project
The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Charles Alexander Nelson III · Academic / Other
- Sex
- All
- Age
- 21 Years – 24 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cognitive Ability, General
- Psychiatric and/or Mood Disorders
- Brain Function
- Social Cognition
- Health Behavior
- Risk-Taking
- Executive Function
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Foster Care Placement | 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. |
Timeline
- Start date
- 2000-09-01
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2008-09-05
- Last updated
- 2025-12-10
Locations
1 site across 1 country: Romania
Source: ClinicalTrials.gov record NCT00747396. Inclusion in this directory is not an endorsement.