The Bucharest Early Intervention Project

Health Behavior Clinical Trial

— BEIP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00747396
• Other study ID #: IRB-P00011741
• Secondary ID: R01MH091363
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2000
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Romania	Fundatia Tanner	Bucharest

Sponsors (12)

Lead Sponsor	Collaborator
Charles Alexander Nelson III	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

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Physiological Reactivity to Stress	Trier Social Stress Test	12 years, 16 years
Primary	Changes in EEG Coherence Brain Function	EEG coherence	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Primary	Changes in EEG Power Brain Function	EEG power	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Primary	Changes in EEG Asymmetry Brain Function	EEG asymmetry	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Primary	Changes in Attachment Disturbances and Disorders	Disturbances of Attachment Interview	baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Primary	Changes in Attachment Style	Strange Situation Procedure	baseline, 30 mos and 42 mos
Primary	Changes in Cognition in later childhood and adolescence	Wechsler Intelligence Scale for Children-IV	8 years, 12 years, 16-18 years
Primary	Changes in Cognition in young adulthood	Wechsler Adult Intelligence Scale	21 years
Primary	Changes in Cognition in early childhood	Bayley Scales of Infant Development	baseline, 30 months, 42 months
Primary	Changes in weight	weight in kilograms	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Primary	Changes in height	Height measured in centimeters	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Primary	Changes in head circumference	Head circumference in centimeters	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Primary	Changes in Psychiatric Symptomatology in adolescence	Diagnostic Interview Schedule for Children -IV	12 years, 16 years
Primary	Changes in Psychiatric Symptomatogology	Preschool And Child Adolescent Psychological Assessment	54 months, 8 years
Primary	Changes in Psychiatric Symptomatogology	Diagnostic Interview Schedule + Substance Abuse Module	21 years
Primary	Changes in Expressive Language Quality	language sample from interview	30 mos, 42 mos and 8 years
Primary	Changes in Caregiving Environment	Observational Record of Caregiving Environment	baseline, 30 mos and 42 mos
Primary	Changes in Indiscriminate Behavior	Stranger at the Door	54 mos, 8 years and 12 years
Primary	Changes in Emotion Discrimination	Event-related Potentials	baseline, 30 mos, 42 mos and 8 years
Primary	Changes in Face Recognition	Event-related Potentials	baseline, 30 mos, 42 mos and 8 years
Primary	Changes in Brain Structure	MRI	8 years, 16 years, 21 years
Primary	Changes in Problem Behaviors	Infant Toddler Social Emotional Assessment	baseline, 30 mos and 42 mos
Primary	Changes in Social Communication and Interaction	Social Communication Questionnaire	baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Primary	Changes in Genetics	Buccal Swab	8 years, 12 years, 16 years
Secondary	Changes in Emotional Reactivity/Temperament	Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo	baseline, 30 mos and 42 mos
Secondary	Motor Skills	Bruininks-Oseretsky Test-2	8 years