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Active, Not Recruiting

NCT Number: NCT00747396

The Bucharest Early Intervention Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundatia Tanner

Bucharest, 011467, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foster Care Placement

Other

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.

Other names: Foster Care Group

Primary outcomes

  1. Changes in EEG Coherence Brain Function

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

    EEG coherence

  2. Changes in EEG Power Brain Function

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

    EEG power

  3. Changes in EEG Asymmetry Brain Function

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

    EEG asymmetry

  4. Changes in Attachment Disturbances and Disorders

    Time frame: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years

    Disturbances of Attachment Interview

  5. Changes in Attachment Style

    Time frame: baseline, 30 mos and 42 mos

    Strange Situation Procedure

  6. Changes in Cognition in later childhood and adolescence

    Time frame: 8 years, 12 years, 16-18 years

    Wechsler Intelligence Scale for Children-IV

  7. Changes in Cognition in young adulthood

    Time frame: 21 years

    Wechsler Adult Intelligence Scale

  8. Changes in Cognition in early childhood

    Time frame: baseline, 30 months, 42 months

    Bayley Scales of Infant Development

  9. Changes in weight

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

    weight in kilograms

  10. Changes in height

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

    Height measured in centimeters

  11. Changes in head circumference

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years

    Head circumference in centimeters

  12. Changes in Psychiatric Symptomatology in adolescence

    Time frame: 12 years, 16 years

    Diagnostic Interview Schedule for Children -IV

  13. Changes in Psychiatric Symptomatogology

    Time frame: 54 months, 8 years

    Preschool And Child Adolescent Psychological Assessment

  14. Changes in Psychiatric Symptomatogology

    Time frame: 21 years

    Diagnostic Interview Schedule + Substance Abuse Module

  15. Changes in Expressive Language Quality

    Time frame: 30 mos, 42 mos and 8 years

    language sample from interview

  16. Changes in Caregiving Environment

    Time frame: baseline, 30 mos and 42 mos

    Observational Record of Caregiving Environment

  17. Changes in Indiscriminate Behavior

    Time frame: 54 mos, 8 years and 12 years

    Stranger at the Door

  18. Changes in Emotion Discrimination

    Time frame: baseline, 30 mos, 42 mos and 8 years

    Event-related Potentials

  19. Changes in Face Recognition

    Time frame: baseline, 30 mos, 42 mos and 8 years

    Event-related Potentials

  20. Changes in Brain Structure

    Time frame: 8 years, 16 years, 21 years

    MRI

  21. Changes in Problem Behaviors

    Time frame: baseline, 30 mos and 42 mos

    Infant Toddler Social Emotional Assessment

  22. Changes in Social Communication and Interaction

    Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years

    Social Communication Questionnaire

  23. Changes in Genetics

    Time frame: 8 years, 12 years, 16 years

    Buccal Swab

Secondary outcomes

  1. Changes in Emotional Reactivity/Temperament

    Time frame: baseline, 30 mos and 42 mos

    Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo

  2. Motor Skills

    Time frame: 8 years

    Bruininks-Oseretsky Test-2

Other outcomes

  1. Changes in Physiological Reactivity to Stress

    Time frame: 12 years, 16 years

    Trier Social Stress Test

Sponsors and collaborators

Lead sponsor

Charles Alexander Nelson III

Other

Collaborators

  • Duke University
  • Harvard University
  • MacArthur Foundation
  • National Institute of Mental Health (NIMH)
  • Temple University
  • Tulane University Health Sciences Center
  • University of Maryland
  • University of Minnesota
  • University of North Carolina, Chapel Hill
  • University of Toronto
  • Vanderbilt University

Registry information

Official study title

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

Acronym: BEIP

Important dates

Study start
2000
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2008
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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