Attention Deficit Hyperactivity DisorderNCT01272726
Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women
An observational study of Attention Deficit Hyperactivity Disorder, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women in and around the Sioux Falls area.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Education
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Also called Attention Deficit Hyperactivity Disorder, Hyperactivity Disorder, Attention Deficit Disorder, Mental Health
Education on the genetics of ADHD and treatment options for ADHD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
To determine if women who think they have ADHD actually have ADHD.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammy Jung, Avera McKennan Hospital & University Health Center
- Investigators
- Timothy Soundy, MD, Principal investigator, Avera McKennan Hospital & University Health CenterKent Andre, MD, Principal investigator, Avera McKennan Hospital & University Health CenterNicole Christensen, MD, Principal investigator, Avera McKennan Hospital & University Health CenterGareth Davies, PhD, Study chair, Avera Institute of Human Behavioral Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272726
- Sponsor's protocol ID
- ARI-1260-ADHD
- Status last verified
- May 2012
- First submitted
- 6 Jan 2011
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15046530Barr 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.
PubMed 10889551Biederman 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.
PubMed 2387786Biederman 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.
PubMed 7771916Faraone 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.
PubMed 11351800Smalley 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.
PubMed 10986810
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women
- ClinicalTrials.gov ID
- NCT01272726
- Acronym / sponsor ID
- ARI-1260-ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Behavioral: EducationWomen 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women in and around the Sioux Falls area.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationAlso: Attention Deficit Hyperactivity Disorder, Hyperactivity Disorder, Attention Deficit Disorder, Mental HealthEducation on the genetics of ADHD and treatment options for ADHD | Behavioural | ADHD |
Primary outcome
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
1 secondary outcome
To determine if women who think they have ADHD actually have ADHD.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Background: PubMed 15046530Murphy KR, Adler LA. Assessing attention-deficit/hyperactivity disorder in adults: focus on rating scales. J Clin Psychiatry. 2004;65 Suppl 3:12-7.
- Background: PubMed 10889551Barr 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.
- Background: PubMed 2387786Biederman 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.
- Background: PubMed 7771916Biederman 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.
- Background: PubMed 11351800Faraone 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.
- Background: PubMed 10986810Smalley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Soundy, MD principal investigator
Avera McKennan Hospital & University Health Center
Kent Andre, MD principal investigator
Avera McKennan Hospital & University Health Center
Nicole Christensen, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272726, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.