- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530758
Does the Format of the Adult ADHD Self-Report Scale Impact the Results
Does the Format of the Adult ADHD Self-Report Scale Impact the Results: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
The ASRS is used widely to screen for ADHD in adults. It has 18 questions, with response options "never," "rarely," "sometimes," "often," and "very often." The 6 questions considered most predictive of ADHD are grouped together in Part A and questions that are meant to provide additional cues are grouped together in Part B. The options that are considered a positive response vary between questions; for some questions the option is at least "sometimes," while for others it is at least "often." The positive response options are shaded on the ASRS. A person is considered to have a positive screen if 4 of the 6 questions in Part A are positive.
The objective of this trial is to determine if the shading and grouping on the ASRS impacts screening results. This trial has a 2x2 factorial design set in a family medicine clinic(s). When a patients check in for an appointment, clinic staff will offer them a survey that includes 1) demographic questions and 2) 1 of the 4 versions of the ASRS, the version they receive is randomized (with programming). Most patients will take approximately 5 minutes to complete the survey prior to them seeing the family physician.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada
- Shifa Medical Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 19 - 65 years old
- Patients who are registering for their appointment at the family medicine clinic
- Patients who are expected to be in the reception area for ≥5 minutes before going to a clinic room
Exclusion Criteria:
- Any patients who do not have the capacity to complete the form (e.g., cognitive impairment, unable to read English, unable to use a computer)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ASRS without shading and with grouping
These participants will receive the ASRS form that does not have shading for the screen positive response options and has the questions grouped (ie, the headings "Part A" and "Part B" will remain on the form).
|
Participants will be asked to complete the ASRS form without shading and with grouping.
|
|
Experimental: ASRS with shading and without grouping
These participants will receive the ASRS form that has the screen positive response options shaded and has the questions ungrouped (ie, the headings "Part A" and "Part B" are removed).
|
Participants will be asked to complete the ASRS form with shading and without grouping.
|
|
Experimental: ASRS without shading and without grouping
These participants will receive the ASRS form that does not have shading for the screen positive response options and has the questions ungrouped (ie, the headings "Part A" and "Part B" are removed).
|
Participants will be asked to complete the ASRS form without shading and without grouping.
|
|
No Intervention: Standard ASRS: with shading and with grouping
These participants will receive the standard ASRS form.
This form has the positive response options for each question shaded and has the questions grouped (ie, the headings "Part A" and "Part B" will remain on the form).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screen positive rate
Time Frame: Through study completion, estimated to be 2 months
|
Poisson regression to determine the relative risk of a screen positive among the different versions of the form.
We will include the following covariates: shading, grouping, shading x grouping, suspect ADHD without diagnosis, ADHD diagnosis, sex, and age.
|
Through study completion, estimated to be 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roni Kraut, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00144202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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