International Adoption and Stress Response Study

Stress Clinical Trial

Official title:

International Adoption and Stress Response Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203944
• Other study ID #: 11685A
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 8, 2013
• Start date: July 2002
• Est. completion date: January 2009

Study information

• Verified date: October 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Behavioral, Development

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol response levels		At clinic visit before and after intervention	No