Psychosocial AdjustmentNCT00368043
Endocrine and Psychological Evaluation of Adopted Children
An observational study of Psychosocial Adjustment, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Adjustment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2006to 30 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- Children with known genetic or chromosomal abnormalities.
- Children with medical conditions known to be associated with permanent developmental delay (i.e. fetal alcohol syndrome).
- Children with chronic medication use.
- Children with behavior problems receiving psychiatric treatment
- Children with documented infectious diseases (AIDS, Hepatitis, etc).
- Children with clinical signs of puberty; only children in Tanner-I pubertal stage will be allowed in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Biobehavioral Study of Recently Adopted Children
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.
Read the 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.
- Conditions
- Psychosocial Adjustment
- Keywords
- Pituitary, Adrenal, Growth, Cortisol, Stress Response, Adoption, Thyroid Hormone, Psychosocial Adjustment, Healthy Volunteer, HV
- Medical subject headings
- Pituitary Diseases, Fractures, Stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study start18 Aug 2006
- Study completion30 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychosocial AdjustmentStudies 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
- Observational
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Margaret F Keil, C.R.N.P., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368043
- Sponsor's protocol ID
- 060223
- Other IDs
- 06-CH-0223
- Status last verified
- 30 Mar 2015
- First submitted
- 23 Aug 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Aguila MC, Pickle RL, Yu WH, McCann SM. Roles of somatostatin and growth hormone-releasing factor in ether stress inhibition of growth hormone release. Neuroendocrinology. 1991 Nov;54(5):515-20. doi: 10.1159/000125946.
PubMed 1684229Albers LH, Johnson DE, Hostetter MK, Iverson S, Miller LC. Health of children adopted from the former Soviet Union and Eastern Europe. Comparison with preadoptive medical records. JAMA. 1997 Sep 17;278(11):922-4.
PubMed 9302245American Academy of Pediatrics Committee on Early Childhood, Adoption & Dependent Care: Initial medical evaluation of an adopted child. Pediatrics. 1991 Sep;88(3):642-4. No abstract available.
PubMed 1881750
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Study of Recently Adopted Children
- ClinicalTrials.gov ID
- NCT00368043
- Acronym / sponsor ID
- 060223
- Conditions
- Psychosocial Adjustment
- Keywords
- Pituitary, Adrenal, Growth, Cortisol, Stress Response, Adoption, Thyroid Hormone, Psychosocial Adjustment
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 18 Aug 2006
- Study completion
- 30 Mar 2015
- First posted
- 24 Aug 2006 (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 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.
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.
Study design
Who may qualify
- Ages
- 10 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Children with known genetic or chromosomal abnormalities.
- Children with medical conditions known to be associated with permanent developmental delay (i.e. fetal alcohol syndrome).
- Children with chronic medication use.
- Children with behavior problems receiving psychiatric treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 1684229Aguila MC, Pickle RL, Yu WH, McCann SM. Roles of somatostatin and growth hormone-releasing factor in ether stress inhibition of growth hormone release. Neuroendocrinology. 1991 Nov;54(5):515-20. doi: 10.1159/000125946.
- Background: PubMed 9302245Albers LH, Johnson DE, Hostetter MK, Iverson S, Miller LC. Health of children adopted from the former Soviet Union and Eastern Europe. Comparison with preadoptive medical records. JAMA. 1997 Sep 17;278(11):922-4.
- Background: PubMed 1881750American Academy of Pediatrics Committee on Early Childhood, Adoption & Dependent Care: Initial medical evaluation of an adopted child. Pediatrics. 1991 Sep;88(3):642-4. No abstract available.
Related trials for Psychosocial Adjustment
Active, not recruiting
The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
Cancer, Social Functioning
Enrolling by invitation
Stage-Matched Psychosocial Intervention for Parent Caregivers of Children With Leukemia in Pakistan
Childhood Leukemia
Not yet recruitingObservational study
A Longitudinal Study on Family Adaptation and Relationship Dynamics in Pediatric Rare Diseases
Rare Diseases
Not yet recruiting
The Effect of Group and Mobile Wellness Coaching Given to Women With Breast Cancer on the Disease
Breast Cancer Females
Recruiting
Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness
Severe Mental Illness, Schizophrenia
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.
Margaret F Keil, C.R.N.P. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosocial Adjustment, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 United States. 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?
The study was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368043, which also lists 3 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 17 Dec 2019.