A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric ADHD
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 663
- Locations
- 1
- Primary Endpoint
- Screening Protocol
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Joseph Biederman, MD
Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Males and females ages 6-17
- •Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child
Exclusion Criteria
- •History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention
- •Any significant medical condition, in the judgment of the investigator
- •Mental retardation
- •Pregnancy or lactation
- •Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence
- •Sensory difficulties such as deafness or blindness
Outcomes
Primary Outcomes
Screening Protocol
Time Frame: Screening
This is a prescreening for potential participation in research studies.