Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 12, 2014
Last verified: May 2014
  Purpose

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
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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00592436

Contacts
Contact: Rebecca Grossman, BA 617-643-1432 rgrossman1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT00592436     History of Changes
Other Study ID Numbers: 2003-P-000239
Study First Received: December 28, 2007
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
pediatric
children

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014