Cognitive Ability, GeneralBEIPNCT00747396
The Bucharest Early Intervention Project
A study testing Foster Care Placement in people with Cognitive Ability, General and Psychiatric and/or Mood Disorders, run by Charles Alexander Nelson III at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 21 to 24 years
- Conditions the study is for
- Cognitive Ability, General, Psychiatric and/or Mood Disorders, Brain Function
- What is being tested?
- Foster Care Placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteRomania
- Study dates
- Sep 2000to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- previously institutionalized and community children that took part in previous BEIP assessments
- target recruitment age is +/- 6 mos of 21st birthday
Who cannot join
- open or closed head injury within the past 12 months
- viral or bacterial meningitis within the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
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.
Read the 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
- Being tested
- Foster Care Placement
- Keywords
- Romania,, children,, foster care,, institutionalization,, brain function,, MRI,, attachment,, language,, growth,, Intelligence Quotient (IQ),, psychiatric symptomatology, early intervention
- Medical subject headings
- Health Behavior, Risk-Taking, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foster Care PlacementOther
Also called Foster Care Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Foster Care Placement Group | Experimental | Children randomized to this group were placed in high quality foster care developed for the study. Receives: Other: Foster Care Placement |
| Care As Usual Group | No intervention | Children randomized to this group remained in institutional care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EEG Coherence Brain Function
EEG coherence
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in EEG Power Brain Function
EEG power
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in EEG Asymmetry Brain Function
EEG asymmetry
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in Attachment Disturbances and Disorders
Disturbances of Attachment Interview
Measured: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Changes in Attachment Style
Strange Situation Procedure
Measured: baseline, 30 mos and 42 mos
Changes in Cognition in later childhood and adolescence
Wechsler Intelligence Scale for Children-IV
Measured: 8 years, 12 years, 16-18 years
Changes in Cognition in young adulthood
Wechsler Adult Intelligence Scale
Measured: 21 years
Changes in Cognition in early childhood
Bayley Scales of Infant Development
Measured: baseline, 30 months, 42 months
Changes in weight
weight in kilograms
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in height
Height measured in centimeters
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in head circumference
Head circumference in centimeters
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Changes in Psychiatric Symptomatology in adolescence
Diagnostic Interview Schedule for Children -IV
Measured: 12 years, 16 years
Changes in Psychiatric Symptomatogology
Preschool And Child Adolescent Psychological Assessment
Measured: 54 months, 8 years
Changes in Psychiatric Symptomatogology
Diagnostic Interview Schedule + Substance Abuse Module
Measured: 21 years
Changes in Expressive Language Quality
language sample from interview
Measured: 30 mos, 42 mos and 8 years
Changes in Caregiving Environment
Observational Record of Caregiving Environment
Measured: baseline, 30 mos and 42 mos
Changes in Indiscriminate Behavior
Stranger at the Door
Measured: 54 mos, 8 years and 12 years
Changes in Emotion Discrimination
Event-related Potentials
Measured: baseline, 30 mos, 42 mos and 8 years
Changes in Face Recognition
Event-related Potentials
Measured: baseline, 30 mos, 42 mos and 8 years
Changes in Brain Structure
MRI
Measured: 8 years, 16 years, 21 years
Changes in Problem Behaviors
Infant Toddler Social Emotional Assessment
Measured: baseline, 30 mos and 42 mos
Changes in Social Communication and Interaction
Social Communication Questionnaire
Measured: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Changes in Genetics
Buccal Swab
Measured: 8 years, 12 years, 16 years
Secondary outcomes (2)
Changes in Emotional Reactivity/Temperament
Laboratory Temperament Assessment Battery (Lab-TAB) Puppets and Peek-a-boo
Measured: baseline, 30 mos and 42 mos
Motor Skills
Bruininks-Oseretsky Test-2
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2000
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Alexander Nelson III
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University Health Sciences Center, University of Maryland, University of Minnesota, Temple University, Duke University, MacArthur Foundation, National Institute of Mental Health (NIMH), Vanderbilt University, Harvard University, University of North Carolina, Chapel Hill, University of Toronto
- Responsible party
- Sponsor-investigator, Charles Alexander Nelson III, Boston Children's Hospital
- Investigators
- Charles A Nelson, Ph.D., Principal investigator, Children's Hospital Boston/Harvard UniversityNathan A. Fox, Ph.D., Principal investigator, University of MarylandCharles H. Zeanah, M.D., Principal investigator, Tulane University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747396
- Sponsor's protocol ID
- IRB-P00011741
- Other IDs
- R01MH091363
- Acronym
- BEIP
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2008
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arnett AB, Antunez M, Zeanah C, Fox NA, Nelson CA. Physical and neurophysiological maturation associated with ADHD among previously institutionalized children: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Jul;66(7):967-979. doi: 10.1111/jcpp.14110. Epub 2025 Jan 11.
PubMed 39797613Guyon-Harris KL, Plamondon A, Humphreys KL, Wade M, Gleason MM, Tibu F, Nelson CA, Fox NA, Zeanah CH. Structure of Psychopathology in Romanian Preschool-Aged Children in an Epidemiological and a High-Risk Sample. JAACAP Open. 2023 Nov;1(3):173-183. doi: 10.1016/j.jaacop.2023.06.004. Epub 2023 Jul 19.
PubMed 38500494King LS, Guyon-Harris KL, Valadez EA, Radulescu A, Fox NA, Nelson CA, Zeanah CH, Humphreys KL. A Comprehensive Multilevel Analysis of the Bucharest Early Intervention Project: Causal Effects on Recovery From Early Severe Deprivation. Am J Psychiatry. 2023 Aug 1;180(8):573-583. doi: 10.1176/appi.ajp.20220672. Epub 2023 May 22.
PubMed 37211832Humphreys KL, Guyon-Harris KL, Tibu F, Wade M, Nelson CA, Fox NA, Zeanah CH. Psychiatric outcomes following severe deprivation in early childhood: Follow-up of a randomized controlled trial at age 16. J Consult Clin Psychol. 2020 Dec;88(12):1079-1090. doi: 10.1037/ccp0000613.
PubMed 33370132Humphreys KL, Machlin LS, Guyon-Harris KL, Nelson CA, Fox NA, Zeanah CH. Psychosocial deprivation and receptive language ability: a two-sample study. J Neurodev Disord. 2020 Dec 16;12(1):36. doi: 10.1186/s11689-020-09341-2.
PubMed 33327936Slopen N, Tang A, Nelson CA, Zeanah CH, McDade TW, McLaughlin KA, Fox NA. The Consequences of Foster Care Versus Institutional Care in Early Childhood on Adolescent Cardiometabolic and Immune Markers: Results From a Randomized Controlled Trial. Psychosom Med. 2019 Jun;81(5):449-457. doi: 10.1097/PSY.0000000000000696.
PubMed 31008902Wade M, Fox NA, Zeanah CH, Nelson CA, Drury SS. Telomere Length and Psychopathology: Specificity and Direction of Effects Within the Bucharest Early Intervention Project. J Am Acad Child Adolesc Psychiatry. 2020 Jan;59(1):140-148.e3. doi: 10.1016/j.jaac.2019.02.013. Epub 2019 Mar 4.
PubMed 30844465Wade M, Fox NA, Zeanah CH, Nelson CA. Effect of Foster Care Intervention on Trajectories of General and Specific Psychopathology Among Children With Histories of Institutional Rearing: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Nov 1;75(11):1137-1145. doi: 10.1001/jamapsychiatry.2018.2556.
PubMed 30267045Johnson DE, Tang A, Almas AN, Degnan KA, McLaughlin KA, Nelson CA, Fox NA, Zeanah CH, Drury SS. Caregiving Disruptions Affect Growth and Pubertal Development in Early Adolescence in Institutionalized and Fostered Romanian Children: A Randomized Clinical Trial. J Pediatr. 2018 Dec;203:345-353.e3. doi: 10.1016/j.jpeds.2018.07.027. Epub 2018 Aug 29.
PubMed 30172435Humphreys KL, Miron D, McLaughlin KA, Sheridan MA, Nelson CA, Fox NA, Zeanah CH. Foster care promotes adaptive functioning in early adolescence among children who experienced severe, early deprivation. J Child Psychol Psychiatry. 2018 Jul;59(7):811-821. doi: 10.1111/jcpp.12865. Epub 2018 Feb 1.
PubMed 29389015Humphreys KL, McGoron L, Sheridan MA, McLaughlin KA, Fox NA, Nelson CA 3rd, Zeanah CH. High-Quality Foster Care Mitigates Callous-Unemotional Traits Following Early Deprivation in Boys: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):977-83. doi: 10.1016/j.jaac.2015.09.010. Epub 2015 Oct 9.
PubMed 26598472Humphreys KL, Gleason MM, Drury SS, Miron D, Nelson CA 3rd, Fox NA, Zeanah CH. Effects of institutional rearing and foster care on psychopathology at age 12 years in Romania: follow-up of an open, randomised controlled trial. Lancet Psychiatry. 2015 Jul;2(7):625-34. doi: 10.1016/S2215-0366(15)00095-4. Epub 2015 Jun 23.
PubMed 26303560Bick J, Zhu T, Stamoulis C, Fox NA, Zeanah C, Nelson CA. Effect of early institutionalization and foster care on long-term white matter development: a randomized clinical trial. JAMA Pediatr. 2015 Mar;169(3):211-9. doi: 10.1001/jamapediatrics.2014.3212.
PubMed 25622303Gleason MM, Fox NA, Drury S, Smyke A, Egger HL, Nelson CA 3rd, Gregas MC, Zeanah CH. Validity of evidence-derived criteria for reactive attachment disorder: indiscriminately social/disinhibited and emotionally withdrawn/inhibited types. J Am Acad Child Adolesc Psychiatry. 2011 Mar;50(3):216-231.e3. doi: 10.1016/j.jaac.2010.12.012. Epub 2011 Feb 1.
PubMed 21334562Bos KJ, Zeanah CH Jr, Smyke AT, Fox NA, Nelson CA 3rd. Stereotypies in children with a history of early institutional care. Arch Pediatr Adolesc Med. 2010 May;164(5):406-11. doi: 10.1001/archpediatrics.2010.47.
PubMed 20439790
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
- ClinicalTrials.gov ID
- NCT00747396
- Acronym / sponsor ID
- BEIP / IRB-P00011741
- Conditions
- Cognitive Ability, General, Psychiatric and/or Mood Disorders, Brain Function, Social Cognition, Health Behavior, Risk-Taking
- Keywords
- Romania,, children,, foster care,, institutionalization,, brain function,, MRI,, attachment,, language,
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Charles Alexander Nelson IIIUniversity, hospital or other
- Collaborators
- Tulane University Health Sciences Center, University of Maryland, University of Minnesota, Temple University, Duke University, MacArthur Foundation, National Institute of Mental Health (NIMH), Vanderbilt University, Harvard University, University of North Carolina, Chapel Hill, University of Toronto
- Study start
- Sep 2000 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foster Care Placement Group | Experimental | Other: Foster Care PlacementChildren randomized to this group were placed in high quality foster care developed for the study. |
| Care As Usual Group | No intervention | –Children randomized to this group remained in institutional care. |
Who may qualify
- Ages
- 21 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- previously institutionalized and community children that took part in previous BEIP assessments
- target recruitment age is +/- 6 mos of 21st birthday
Key exclusion criteria (2 listed)
- open or closed head injury within the past 12 months
- viral or bacterial meningitis within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foster Care PlacementAlso: Foster Care GroupA 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 | Foster Care Placement Group |
Primary outcome
Changes in EEG Coherence Brain Function
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
EEG coherence
Changes in EEG Power Brain Function
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
EEG power
Changes in EEG Asymmetry Brain Function
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
EEG asymmetry
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
Changes in Attachment Style
Time frame: baseline, 30 mos and 42 mos
Strange Situation Procedure
Changes in Cognition in later childhood and adolescence
Time frame: 8 years, 12 years, 16-18 years
Wechsler Intelligence Scale for Children-IV
Changes in Cognition in young adulthood
Time frame: 21 years
Wechsler Adult Intelligence Scale
Changes in Cognition in early childhood
Time frame: baseline, 30 months, 42 months
Bayley Scales of Infant Development
Changes in weight
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
weight in kilograms
Changes in height
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Height measured in centimeters
Changes in head circumference
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Head circumference in centimeters
Changes in Psychiatric Symptomatology in adolescence
Time frame: 12 years, 16 years
Diagnostic Interview Schedule for Children -IV
Changes in Psychiatric Symptomatogology
Time frame: 54 months, 8 years
Preschool And Child Adolescent Psychological Assessment
Changes in Psychiatric Symptomatogology
Time frame: 21 years
Diagnostic Interview Schedule + Substance Abuse Module
Changes in Expressive Language Quality
Time frame: 30 mos, 42 mos and 8 years
language sample from interview
Changes in Caregiving Environment
Time frame: baseline, 30 mos and 42 mos
Observational Record of Caregiving Environment
Changes in Indiscriminate Behavior
Time frame: 54 mos, 8 years and 12 years
Stranger at the Door
Changes in Emotion Discrimination
Time frame: baseline, 30 mos, 42 mos and 8 years
Event-related Potentials
Changes in Face Recognition
Time frame: baseline, 30 mos, 42 mos and 8 years
Event-related Potentials
Changes in Brain Structure
Time frame: 8 years, 16 years, 21 years
MRI
Changes in Problem Behaviors
Time frame: baseline, 30 mos and 42 mos
Infant Toddler Social Emotional Assessment
Changes in Social Communication and Interaction
Time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Social Communication Questionnaire
Changes in Genetics
Time frame: 8 years, 12 years, 16 years
Buccal Swab
2 secondary outcomes
Changes in Emotional Reactivity/Temperament
Time frame: baseline, 30 mos and 42 mos
Motor Skills
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 39797613Arnett AB, Antunez M, Zeanah C, Fox NA, Nelson CA. Physical and neurophysiological maturation associated with ADHD among previously institutionalized children: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Jul;66(7):967-979. doi: 10.1111/jcpp.14110. Epub 2025 Jan 11.
- Derived from this study: PubMed 38500494Guyon-Harris KL, Plamondon A, Humphreys KL, Wade M, Gleason MM, Tibu F, Nelson CA, Fox NA, Zeanah CH. Structure of Psychopathology in Romanian Preschool-Aged Children in an Epidemiological and a High-Risk Sample. JAACAP Open. 2023 Nov;1(3):173-183. doi: 10.1016/j.jaacop.2023.06.004. Epub 2023 Jul 19.
- Derived from this study: PubMed 37211832King LS, Guyon-Harris KL, Valadez EA, Radulescu A, Fox NA, Nelson CA, Zeanah CH, Humphreys KL. A Comprehensive Multilevel Analysis of the Bucharest Early Intervention Project: Causal Effects on Recovery From Early Severe Deprivation. Am J Psychiatry. 2023 Aug 1;180(8):573-583. doi: 10.1176/appi.ajp.20220672. Epub 2023 May 22.
- Derived from this study: PubMed 33370132Humphreys KL, Guyon-Harris KL, Tibu F, Wade M, Nelson CA, Fox NA, Zeanah CH. Psychiatric outcomes following severe deprivation in early childhood: Follow-up of a randomized controlled trial at age 16. J Consult Clin Psychol. 2020 Dec;88(12):1079-1090. doi: 10.1037/ccp0000613.
- Derived from this study: PubMed 33327936Humphreys KL, Machlin LS, Guyon-Harris KL, Nelson CA, Fox NA, Zeanah CH. Psychosocial deprivation and receptive language ability: a two-sample study. J Neurodev Disord. 2020 Dec 16;12(1):36. doi: 10.1186/s11689-020-09341-2.
- Derived from this study: PubMed 31008902Slopen N, Tang A, Nelson CA, Zeanah CH, McDade TW, McLaughlin KA, Fox NA. The Consequences of Foster Care Versus Institutional Care in Early Childhood on Adolescent Cardiometabolic and Immune Markers: Results From a Randomized Controlled Trial. Psychosom Med. 2019 Jun;81(5):449-457. doi: 10.1097/PSY.0000000000000696.
- Derived from this study: PubMed 30844465Wade M, Fox NA, Zeanah CH, Nelson CA, Drury SS. Telomere Length and Psychopathology: Specificity and Direction of Effects Within the Bucharest Early Intervention Project. J Am Acad Child Adolesc Psychiatry. 2020 Jan;59(1):140-148.e3. doi: 10.1016/j.jaac.2019.02.013. Epub 2019 Mar 4.
- Derived from this study: PubMed 30267045Wade M, Fox NA, Zeanah CH, Nelson CA. Effect of Foster Care Intervention on Trajectories of General and Specific Psychopathology Among Children With Histories of Institutional Rearing: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Nov 1;75(11):1137-1145. doi: 10.1001/jamapsychiatry.2018.2556.
- Derived from this study: PubMed 30172435Johnson DE, Tang A, Almas AN, Degnan KA, McLaughlin KA, Nelson CA, Fox NA, Zeanah CH, Drury SS. Caregiving Disruptions Affect Growth and Pubertal Development in Early Adolescence in Institutionalized and Fostered Romanian Children: A Randomized Clinical Trial. J Pediatr. 2018 Dec;203:345-353.e3. doi: 10.1016/j.jpeds.2018.07.027. Epub 2018 Aug 29.
- Derived from this study: PubMed 29389015Humphreys KL, Miron D, McLaughlin KA, Sheridan MA, Nelson CA, Fox NA, Zeanah CH. Foster care promotes adaptive functioning in early adolescence among children who experienced severe, early deprivation. J Child Psychol Psychiatry. 2018 Jul;59(7):811-821. doi: 10.1111/jcpp.12865. Epub 2018 Feb 1.
- Derived from this study: PubMed 26598472Humphreys KL, McGoron L, Sheridan MA, McLaughlin KA, Fox NA, Nelson CA 3rd, Zeanah CH. High-Quality Foster Care Mitigates Callous-Unemotional Traits Following Early Deprivation in Boys: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):977-83. doi: 10.1016/j.jaac.2015.09.010. Epub 2015 Oct 9.
- Derived from this study: PubMed 26303560Humphreys KL, Gleason MM, Drury SS, Miron D, Nelson CA 3rd, Fox NA, Zeanah CH. Effects of institutional rearing and foster care on psychopathology at age 12 years in Romania: follow-up of an open, randomised controlled trial. Lancet Psychiatry. 2015 Jul;2(7):625-34. doi: 10.1016/S2215-0366(15)00095-4. Epub 2015 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles A Nelson, Ph.D. principal investigator
Children's Hospital Boston/Harvard University
Nathan A. Fox, Ph.D. principal investigator
University of Maryland
Charles H. Zeanah, M.D. principal investigator
Tulane University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foster Care Placement in people with Cognitive Ability, General and Psychiatric and/or Mood Disorders, run by Charles Alexander Nelson III at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EEG Coherence Brain Function (time frame: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747396, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.