Expired Study
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Chicago, Illinois 60637


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.


Study summary:

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.


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


Study is Available At:


Original ID:

11685A


NCT ID:

NCT00203944


Secondary ID:


Study Acronym:


Brief Title:

International Adoption and Stress Response Study


Official Title:

International Adoption and Stress Response Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

1 Year


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

39


Enrollment Type:

Actual


Overall Contact Information

Official Name:Larry Gray, M.D.
Principal Investigator
University of Chicago

Study Dates

Start Date:July 2002
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:October 2013
Last Changed Date:October 8, 2013
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cortisol response levels
Time Frame:At clinic visit before and after intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Behavioral, Development
Arm Name:international adopted infants

Study Arms

Study Arm Type:Other
Arm Name:Control infants
Study Arm Type:Other
Arm Name:international adopted infants
Description:international adoptees making their first visit to international adoption clinic

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago

Samples and Retentions

Study Population: infants from international adoption clinic for adoptees and U of C pediatric follow-up clinic for controls
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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