NCT01037569

Brief Summary

Background:

  • Children who enter the foster care system are all too often exposed to illicit drugs in the home. Children from these homes, known as drug endangered children, are not routinely tested for harmful substances. Any short- and long-term physical or developmental problems they may experience as a result of this exposure often go undetected and untreated.
  • Children who are placed into protective custody are not always screened by physicians or nurse practitioners. Although drug-endangered children under 18 years of age automatically receive a urine toxicology screen to determine the types and levels of illicit drugs in their systems, this procedure has difficulties and limitations that may affect the quality of the data. Researchers are interested in developing more effective methods of analyzing the presence or absence of illicit environmental drug exposure in children. Objectives: \- To determine the most effective method of identifying long-term illicit stimulant drug exposure in drug-endangered children. Eligibility: \- Children under 18 years of age who are being placed into protective custody after having been found in a home where drugs are manufactured, used, or sold. Design:
  • Researchers will gain verbal consent for the procedure for children who are 7 years of age or older. Children younger than 7 years of age will not be required to give verbal consent for sample collection.
  • Researchers will collect standard urine samples for toxicological screening. Part of the sample will be sent to the National Institute on Drug Abuse for evaluation; the rest will remain with the local authority.
  • In addition to this standard procedure, researchers will collect a hair sample by cutting a small amount of hair from the crown of the head as close to the root as possible (and not pulling any hair out of the child's head).
  • Researchers will also use an oral swab to collect a saliva sample from the inside cheek of each child.
  • No clinical care will be provided under this protocol....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Typical duration 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 10, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2011

Completed
Last Updated

July 2, 2017

Status Verified

March 22, 2011

First QC Date

December 19, 2009

Last Update Submit

June 30, 2017

Conditions

Keywords

Toxicological ScreeningDrugsAlternative MatricesUrineChildren

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children under the age of 18 (the vast majority - 87 percent - of children examined at the Center are under the age of 6);
  • children placed into protective custody by Sacramento County CPS or law enforcement;
  • children examined at the CAARE Center; and
  • children found in a home where drugs are manufactured, used and/or sold.

You may not qualify if:

  • anyone who has reached the age of majority;
  • those found to have parents who are not drug abusers;
  • those where there was no definitive evidence of environmental drug exposure (i.e., suspicious parent, but no drugs were found in the home); or
  • any child, drug exposed or not, who is examined in the UCD Emergency Department (after hours - 9:00 pm to 7:00 am - and weekends).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 19, 2009

First Posted

December 23, 2009

Study Start

July 10, 2007

Study Completion

March 22, 2011

Last Updated

July 2, 2017

Record last verified: 2011-03-22

Locations