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International Adoption and Stress Response Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00203944
First Posted: September 20, 2005
Last Update Posted: October 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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 Intervention
Stress Behavioral: Behavioral, Development

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: International Adoption and Stress Response Study

Resource links provided by NLM:


Further study details as provided by University of Chicago:

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

Enrollment: 39
Study Start Date: July 2002
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
international adopted infants
international adoptees making their first visit to international adoption clinic
Behavioral: Behavioral, Development
Control infants

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.

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children greater than 1 year old
  Contacts and Locations
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


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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00203944     History of Changes
Other Study ID Numbers: 11685A
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by University of Chicago:
Adoption
Stress Response
Child Development