- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181857
Risk of Attention Deficit Hyperactivity Disorder (ADHD) in the Children of Adults With ADHD Not Otherwise Specified (NOS)
Risk of Attention Deficit Hyperactivity Disorder in the Children of Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified: A Pilot Study
Study Overview
Status
Conditions
Detailed Description
We plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. We hypothesize the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.
The proposed study includes a one-time fifteen minute survey derived from the ADHD module of the Kiddie Schedule for Affective Disorders - Epidemiological Version (KSADS-E) with the proband of an ADHD NOS study regarding his/her children, in order to assess possible ADHD symptoms of that child. We also ask "school questions" regarding certain aspects of a child's educational experience.
Study Type
Enrollment (Actual)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Must be a biological child of an ADHD NOS proband. The proband must meet the following criterion:
- Age: above 18 years
- Sex: male or female
- Intelligence quotient (IQ) above 80
Met criteria for the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:
- having at least 6 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity but < 5 items from either list in childhood, or
- having 5 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity, but not having the 6 current symptoms in either category. This second category will be included independent of the presence or absence of ADHD symptoms in childhood.
- Had a Clinical Global Impression: ADHD score of 4 (moderately ill) or higher illness severity at a clinical evaluation.
- Has at least one biological offspring
Exclusion Criteria:
- No adequate informant is available to answer the survey questions.
- Sensorimotor deficits. (These include deficits that would impede the survey process, e.g. profound deafness, blindness, inadequate command of the English language, or profound disorders of language.)
- Psychosis, autism, schizophrenia.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Children of Adults with ADHD NOS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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ADHD Diagnosis
Time Frame: at evaluation
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at evaluation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Craig Surman, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-P-002687
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.
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