Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tammy Jung, Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01272726
First received: January 6, 2011
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: Education

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if women who think they have ADHD actually have ADHD. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

saliva


Enrollment: 60
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Education
Education on the genetics of ADHD and treatment options for ADHD
Other Names:
  • Attention Deficit Hyperactivity Disorder
  • Hyperactivity Disorder
  • Attention Deficit Disorder
  • Mental Health

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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women in and around the Sioux Falls area.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272726

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
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
  More Information

Publications:
Responsible Party: Tammy Jung, Regulatory Specialist, Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01272726     History of Changes
Other Study ID Numbers: ARI-1260-ADHD
Study First Received: January 6, 2011
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014