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International Adoption and Stress Response Study

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ClinicalTrials.gov Identifier: NCT00203944
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 9, 2013
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
This study aims to provide information about the emotional and physiological responses of post-institutionalized children in both a stressful situation (immunization) and a play situation.

Condition or disease Intervention/treatment
Stress Behavioral: Behavioral, Development

Detailed Description:

During the last decade, international adoptions have doubled in the United States. Because many of these infants and children have experienced institutionalization and poor caretaking before their adoption, international adoptees have special medical and emotional needs that must be met by both their parents and pediatricians. Currently, most clinical information about these children has focused on their physical health status so that protocols for evaluation and treatment can be established. Some systematic research has also focused on their overall developmental status including both cognitive and motor capabilities. These studies show that most of the children are developmentally delayed upon arrival to the U.S. Furthermore, follow-up studies have found international adoptees to score (on the average) significantly lower in cognitive functioning than their nonadopted peers even after spending substantial time in their adopting homes and falling mostly within the normal range. Not surprisingly, children's level of functioning at older ages is related to the length of time spent in institutional care.

These findings are consistent with an emerging literature on the lingering effects of early adversity on children's development. Potent adverse circumstances may include the unbuffered effects of poverty, experience in an institutional setting, physical or sexual abuse, and parental negligence Regardless of the source, children who are not protected from these disadvantageous situations demonstrate changes in their behavior as well as their biophysiological regulation.

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: International Adoption and Stress Response Study
Study Start Date : July 2002
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption
U.S. FDA Resources

Group/Cohort Intervention/treatment
international adopted infants
international adoptees making their first visit to international adoption clinic
Behavioral: Behavioral, Development
Control infants

Primary Outcome Measures :
  1. Cortisol response levels [ Time Frame: At clinic visit before and after intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
infants from international adoption clinic for adoptees and U of C pediatric follow-up clinic for controls

Inclusion Criteria:

  • Infants less than 1 year old
  • Adopted infants
  • Control group of non-adopted infants

Exclusion Criteria:

  • Children greater than 1 year old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203944

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Larry Gray, M.D. University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00203944     History of Changes
Other Study ID Numbers: 11685A
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by University of Chicago:
Stress Response
Child Development