Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00592436
Recruitment Status : Terminated (New protocol developed for recruitment of children for all child studies)
First Posted : January 14, 2008
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease
Pediatric ADHD

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 663 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
Study Start Date : March 2003
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Screening Protocol [ Time Frame: Screening ]
    This is a prescreening for potential participation in research studies.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with symptoms of ADHD

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00592436

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital

Additional Information:
Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital Identifier: NCT00592436     History of Changes
Other Study ID Numbers: 2003-P-000239
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders