Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

This study is currently recruiting participants.
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592436
First received: December 28, 2007
Last updated: October 21, 2013
Last verified: October 2013

December 28, 2007
October 21, 2013
March 2003
December 2020   (final data collection date for primary outcome measure)
Screening Protocol [ Time Frame: Screening ] [ Designated as safety issue: No ]
This is a prescreening for potential participation in research studies.
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Complete list of historical versions of study NCT00592436 on ClinicalTrials.gov Archive Site
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Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies.

The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Children with symptoms of ADHD

Pediatric ADHD
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1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and females ages 6-17
  2. Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child

Exclusion Criteria:

  1. History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention
  2. Any significant medical condition, in the judgment of the investigator
  3. Mental retardation
  4. Pregnancy or lactation
  5. Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence
  6. Sensory difficulties such as deafness or blindness
Both
6 Years to 17 Years
No
Contact: Rebecca Grossman, BA 617-643-1432 rgrossman1@partners.org
United States
 
NCT00592436
2003-P-000239
No
Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP