NCT01272726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

January 6, 2011

Last Update Submit

May 31, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (1)

  • To determine if women who think they have ADHD actually have ADHD.

    24 hours

Study Arms (1)

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

Interventions

EducationBEHAVIORAL

Education on the genetics of ADHD and treatment options for ADHD

Also known as: Attention Deficit Hyperactivity Disorder, Hyperactivity Disorder, Attention Deficit Disorder, Mental Health
ADHD

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women in and around the Sioux Falls area.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (6)

  • Murphy KR, Adler LA. Assessing attention-deficit/hyperactivity disorder in adults: focus on rating scales. J Clin Psychiatry. 2004;65 Suppl 3:12-7.

    PMID: 15046530BACKGROUND
  • 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.

    PMID: 10889551BACKGROUND
  • 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.

    PMID: 2387786BACKGROUND
  • 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.

    PMID: 7771916BACKGROUND
  • 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.

    PMID: 11351800BACKGROUND
  • 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.

    PMID: 10986810BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Educational StatusMental Health

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsHealth

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Gareth Davies, PhD

    Avera Institute of Human Behavioral Genetics

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Regulatory Specialist

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 10, 2011

Study Start

March 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations