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Endocrine and Psychological Evaluation of Adopted Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00368043
First received: August 23, 2006
Last updated: November 11, 2014
Last verified: June 2014
  Purpose

The deleterious effects of institutionalized care on the health and growth and development of children have been described. Early studies have shown that the effects of institutionalized care on a child's growth and development may not be fully reversible. The exact mechanism through which these early stresses affect bio-behavioral outcomes has yet to be determined. A likely mechanism in which environmental influences could regulate both biological and psychosocial development may be through the hypothalamic pituitary adrenal axis (HPA). Recent advances in the area of brain research have enriched our understanding of the importance of early life experiences on physical, cognitive, developmental, mental and behavioral health outcomes. Children adopted from orphanages in countries as diverse as the former Soviet Union and Guatemala provide an opportunity to learn more about the effect of deprivation on neuro-endocrine function, physical growth, and developmental outcomes, including cognitive, and behavioral measures.

This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child, ages 10 months to 4 years, which may help elucidate the etiology of the complex findings in this population. We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls. Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system. HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels, increased cortisol and/or catecholamine excretion in 24 hours urine measurements, and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders. In addition, we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome.


Condition
Psychosocial Adjustment

Study Type: Observational
Official Title: Biobehavioral Study of Recently Adopted Children

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 38
Study Start Date: August 2006
Detailed Description:

The deleterious effects of institutionalized care on the health and growth and development of children have been described. Early studies have shown that the effects of institutionalized care on a child's growth and development may not be fully reversible. The exact mechanism through which these early stresses affect bio-behavioral outcomes has yet to be determined. A likely mechanism in which environmental influences could regulate both biological and psychosocial development may be through the hypothalamic pituitary adrenal axis (HPA). Recent advances in the area of brain research have enriched our understanding of the importance of early life experiences on physical, cognitive, developmental, mental and behavioral health outcomes. Children adopted from orphanages in countries as diverse as the former Soviet Union and Guatemala provide an opportunity to learn more about the effect of deprivation on neuro-endocrine function, physical growth, and developmental outcomes, including cognitive and behavioral measures.

This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child, ages 10 months to 4 years, which may help elucidate the etiology of the complex findings in this population. We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls. Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system. HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels, increased cortisol and/or catecholamine excretion in 24 hours urine measurements, and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders. In addition, we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome.

  Eligibility

Ages Eligible for Study:   10 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A. The patient sample will be children ages 10 months to 4 years old (pre-pubertal, Tanner I) referred to the International Adoption Center or Johns Hopkins University Medical Center for an initial evaluation within two to four weeks after they arrive from their country of origin (Eastern Europe/Russia).

A total of 60 children, ages 10 months to 6 years, will be recruited for a control group and will be frequency matched with the adopted subjects into four strata: 10 to 42 month old boys, 10 to 42 month old girls, 43 to 72 month old boys, and 43 to 72 month old girls.

The controls will be healthy children with no history of medical or psychological disorders

The controls will be healthy children with no history of medical or psychological disorders.

EXCLUSION CRITERIA:

  1. Children with known documented growth hormone deficiency, and/or history of chronic illness such as renal failure, severe chronic lung disease (restrictive, obstructive) diabetes, hypothyroidism.
  2. Children with known genetic or chromosomal abnormalities.
  3. Children with medical conditions known to be associated with permanent developmental delay (i.e. fetal alcohol syndrome).
  4. Children with chronic medication use.
  5. Children with behavior problems receiving psychiatric treatment
  6. Children with documented infectious diseases (AIDS, Hepatitis, etc).
  7. Children with clinical signs of puberty; only children in Tanner-I pubertal stage will be allowed in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368043

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret F Keil, C.R.N.P. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier: NCT00368043     History of Changes
Other Study ID Numbers: 060223, 06-CH-0223
Study First Received: August 23, 2006
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pituitary
Adrenal
Growth
Cortisol
Stress Response
Adoption
Thyroid Hormone
Psychosocial Adjustment
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on November 20, 2014