Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
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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 |
| 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 |
Children with symptoms of ADHD
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
Contacts and Locations| Contact: Katie McDermott, BS | 617-726-4651 | kmmcdermott@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| 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: | April 22, 2013 |
| 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 May 16, 2013