Clinical trial NCT01272726: Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women
Official title: Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in and around the Sioux Falls area.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 hours
Secondary outcomes:
measure: To determine if women who think they have ADHD actually have ADHD.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Timothy Soundy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Avera McKennan Hospital & University Health Center
name: Kent Andre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Avera McKennan Hospital & University Health Center
name: Nicole Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Avera Institute of Human Behavioral Genetics
name: Gareth Davies, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.