MedDataX Logo

International Adoption and Stress Response Study

NCT ID: NCT00203944

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-07-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Adoption Stress Response Child Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

international adopted infants

international adoptees making their first visit to international adoption clinic

Behavioral, Development

Intervention Type BEHAVIORAL

Control infants

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral, Development

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Children greater than 1 year old
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Larry Gray, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11685A

Identifier Type: -

Identifier Source: org_study_id