Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
May 5, 2015 updated by: Joseph Biederman, MD, Massachusetts General Hospital
A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
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.
Study Overview
Status
Terminated
Conditions
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
Enrollment (Actual)
663
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with symptoms of ADHD
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Screening Protocol
Time Frame: Screening
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This is a prescreening for potential participation in research studies.
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Screening
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
December 28, 2007
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003-P-000239
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.