- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272726
Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women
May 31, 2012 updated by: Tammy Jung, Avera McKennan Hospital & University Health Center
The goal of this research study is to measure what percentage of women who suspect they have symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards.
The study will also evaluate the influence education on the genetics of ADHD has on a woman in her deciding to receive behavioral health treatment for ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) affects approximately 10-12% of school-aged children in the United States, making it one of the most common psychiatric disorders in children.
It is characterized as inattention and hyperactivity-impulsivity, which has persisted for at least 6 months to a degree that is maladaptive and inconsistent with developmental level (DSM-IV-TR).
ADHD is a non-fluctuating illness unlike many other psychiatric co-morbid conditions.
Study Type
Observational
Enrollment (Actual)
60
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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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Research Institute
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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
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women in and around the Sioux Falls area.
Description
Inclusion Criteria:
- Subjects must be females, 18 through 59 years of age
- Subjects must think they have ADHD or have been previously diagnosed with ADHD but may not have received any treatment for ADHD
- Subjects must be able to participate in the informed consent process and give their written consent to participate in the study
Exclusion Criteria:
- Subjects who have been treated (at any time) for ADHD will be excluded from the study
- Potential subjects consuming greater than 21 units of alcohol (1 unit=12.0 ounces beer, 1.5 ounces hard liquor or 5.0 ounces wine) a week will be excluded from the study
- Potential subjects currently experiencing suicidal ideation or who have been hospitalized within the past six months for suicidal ideation will be excluded from the study
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ADHD
Women with symptoms of ADHD.
Women who either think they may have ADHD or have been previously diagnosed with ADHD but have not been treated for it.
|
Education on the genetics of ADHD and treatment options for ADHD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine if offering relative risk genotyping for ADHD, and educating around the genetic and environmental contributions to ADHD, may lead to greater health care acceptance in women who struggle with ADHD.
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine if women who think they have ADHD actually have ADHD.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Timothy Soundy, MD, Avera McKennan Hospital & University Health Center
- Principal Investigator: Kent Andre, MD, Avera McKennan Hospital & University Health Center
- Principal Investigator: Nicole Christensen, MD, Avera McKennan Hospital & University Health Center
- Study Chair: Gareth Davies, PhD, Avera Institute of Human Behavioral Genetics
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.
General Publications
- Murphy KR, Adler LA. Assessing attention-deficit/hyperactivity disorder in adults: focus on rating scales. J Clin Psychiatry. 2004;65 Suppl 3:12-7.
- Barr CL, Feng Y, Wigg K, Bloom S, Roberts W, Malone M, Schachar R, Tannock R, Kennedy JL. Identification of DNA variants in the SNAP-25 gene and linkage study of these polymorphisms and attention-deficit hyperactivity disorder. Mol Psychiatry. 2000 Jul;5(4):405-9. doi: 10.1038/sj.mp.4000733.
- Biederman J, Faraone SV, Keenan K, Knee D, Tsuang MT. Family-genetic and psychosocial risk factors in DSM-III attention deficit disorder. J Am Acad Child Adolesc Psychiatry. 1990 Jul;29(4):526-33. doi: 10.1097/00004583-199007000-00004.
- Biederman J, Milberger S, Faraone SV, Kiely K, Guite J, Mick E, Ablon S, Warburton R, Reed E. Family-environment risk factors for attention-deficit hyperactivity disorder. A test of Rutter's indicators of adversity. Arch Gen Psychiatry. 1995 Jun;52(6):464-70. doi: 10.1001/archpsyc.1995.03950180050007.
- Faraone SV, Doyle AE. The nature and heritability of attention-deficit/hyperactivity disorder. Child Adolesc Psychiatr Clin N Am. 2001 Apr;10(2):299-316, viii-ix.
- Smalley SL, McGough JJ, Del'Homme M, NewDelman J, Gordon E, Kim T, Liu A, McCracken JT. Familial clustering of symptoms and disruptive behaviors in multiplex families with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1135-43. doi: 10.1097/00004583-200009000-00013.
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, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 6, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Estimate)
June 1, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARI-1260-ADHD
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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