The Bucharest Early Intervention Project

NCT00747396 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Tulane University Health Sciences Center

    collaborator OTHER
  • University of Maryland

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • Temple University

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • MacArthur Foundation

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Vanderbilt University

    collaborator OTHER
  • Harvard University

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • University of Toronto

    collaborator OTHER
  • Charles Alexander Nelson III

    lead OTHER

Principal Investigators

  • Charles A Nelson, Ph.D. · Children's Hospital Boston/Harvard University

  • Nathan A. Fox, Ph.D. · University of Maryland

  • Charles H. Zeanah, M.D. · Tulane University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Romania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00747396 on ClinicalTrials.gov