Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Massachusetts General Hospital
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital Identifier:
First received: December 28, 2007
Last updated: November 5, 2014
Last verified: November 2014

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.

Pediatric ADHD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Screening Protocol [ Time Frame: Screening ] [ Designated as safety issue: No ]
    This is a prescreening for potential participation in research studies.

Estimated Enrollment: 750
Study Start Date: March 2003
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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.


Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00592436

Contact: Leah Feinberg, BS 617-726-4651

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

Additional Information:
No publications provided

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
Study First Received: December 28, 2007
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood processed this record on March 26, 2015