Attention-Deficit/Hyperactivity Disorder (ADHD)NCT00711724
Comparison of Self and Clinician Administered Rating Scales in Patients With ADHD
An observational study of Attention-Deficit/Hyperactivity Disorder (ADHD), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective is to establish the concurrent validity of the clinician administered Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Mar 2009
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who are enrolled in the study Protocol 2003-P-001313: "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA."
Who may be able to join
- Diagnosis of ADHD
- Age 13-65* *Parental consent and patient's assent will be obtained for minors participating in this protocol (only adolescents aged 13-18 yrs old will be included in the MGH site)
Who cannot join
- Inability to reliably report ADHD symptoms at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: Comparison of Self and Clinician Administered Rating Scales in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
The primary objective is to establish the concurrent validity of the clinician administered Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Adolescent
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MGH 1 | Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ADHD-RS and ASRS v1.1 Symptom Checklist scales
Measured: Weeks 1, 2, 3, 4, 5, 6, 7, or 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Paul Hammerness, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711724
- Sponsor's protocol ID
- 2007-P-000911
- Status last verified
- Jun 2010
- First submitted
- 3 Jul 2008
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self and Clinician Administered Rating Scales in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00711724
- Acronym / sponsor ID
- 2007-P-000911
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Jul 2008 (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 primary objective is to establish the concurrent validity of the clinician administered Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGH 1 | – | –Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who are enrolled in the study Protocol 2003-P-001313: "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA."
Key inclusion criteria (2 listed)
- Diagnosis of ADHD
- Age 13-65* *Parental consent and patient's assent will be obtained for minors participating in this protocol (only adolescents aged 13-18 yrs old will be included in the MGH site)
Key exclusion criteria (1 listed)
- Inability to reliably report ADHD symptoms at the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ADHD-RS and ASRS v1.1 Symptom Checklist scales
Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, or 8
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 23 Jun 2010.
- Related InfoLink provided by the sponsor.
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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.
Paul Hammerness, MD principal investigator
Massachusetts General Hospital
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 (ADHD), run by Massachusetts General Hospital 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 2 inclusion and 1 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 23 Jun 2010. 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?
The ADHD-RS and ASRS v1.1 Symptom Checklist scales (time frame: Weeks 1, 2, 3, 4, 5, 6, 7, or 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2010.