NCT00203944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

6.5 years

First QC Date

September 13, 2005

Last Update Submit

October 8, 2013

Conditions

Stress

Keywords

AdoptionStress ResponseChild Development

Outcome Measures

Primary Outcomes (1)

  • Cortisol response levels

    At clinic visit before and after intervention

Study Arms (2)

international adopted infants

international adoptees making their first visit to international adoption clinic

Behavioral: Behavioral, Development

Control infants

Interventions

Behavioral, DevelopmentBEHAVIORAL
international adopted infants

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infants from international adoption clinic for adoptees and U of C pediatric follow-up clinic for controls

You may qualify if:

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

You may not qualify if:

  • Children greater than 1 year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Growth and Development

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Physiological Phenomena

Study Officials

  • Larry Gray, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2002

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

US(1)