Attention Deficit Hyperactivity DisorderNCT06530758
Does the Format of the Adult ADHD Self-Report Scale Impact the Results
A study testing Altered ASRS format, without shading and with grouping, Altered ASRS format, with shading and without grouping and Altered ASRS format, without shading and without grouping in people with Attention Deficit Hyperactivity Disorder, run by University of Alberta at 1 site in Canada.
Trial summary
The World Health Organization Adult ADHD Self-Report Scale v1.1 (ASRS) is frequently used in family medicine clinics to screen for ADHD. Numerous studies have found the ASRS has a low positive predictive value. Compounding this concern is the format of the ASRS. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Altered ASRS format, without shading and with grouping, Altered ASRS format, with shading and without grouping and Altered ASRS format, without shading and without grouping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2024to 31 Oct 2024
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Format of the Adult ADHD Self-Report Scale Impact the Results: a Randomized Controlled Trial
The World Health Organization Adult ADHD Self-Report Scale v1.1 (ASRS) is frequently used in family medicine clinics to screen for ADHD. Numerous studies have found the ASRS has a low positive predictive value. Compounding this concern is the format of the ASRS. Specifically, the answers on the ASRS that lead to screen positive results are shaded in gray and grouped together, which may make it easy for patients to discern which responses should be selected for a positive screen.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Altered ASRS format, without shading and with grouping, Altered ASRS format, with shading and without grouping, Altered ASRS format, without shading and without grouping
- 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.
Altered ASRS format, without shading and with groupingOther
Participants will be asked to complete the ASRS form without shading and with grouping.
Altered ASRS format, with shading and without groupingOther
Participants will be asked to complete the ASRS form with shading and without grouping.
Altered ASRS format, without shading and without groupingOther
Participants will be asked to complete the ASRS form without shading and without grouping.
| Study group | Role | What they receive |
|---|---|---|
| ASRS without shading and with grouping | Experimental | 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). Receives: Other: Altered ASRS format, without shading and with grouping |
| ASRS with shading and without grouping | Experimental | 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). Receives: Other: Altered ASRS format, with shading and without grouping |
| ASRS without shading and without grouping | Experimental | 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). Receives: Other: Altered ASRS format, without shading and without grouping |
| Standard ASRS: with shading and with grouping | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Screen positive rate
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.
Measured: Through study completion, estimated to be 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start29 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roni Kraut, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530758
- Sponsor's protocol ID
- Pro00144202
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kraut RY, Ono C, Garrison S, Kamal O, Doroshuk ML, Vandermeer B, Amanna G, Babenko O. Does the format of the adult ADHD self-report scale influence screen-positive rates? A randomized controlled trial in primary care. Front Psychiatry. 2026 Jan 2;16:1646293. doi: 10.3389/fpsyt.2025.1646293. eCollection 2025.
PubMed 41551194
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Format of the Adult ADHD Self-Report Scale Impact the Results: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06530758
- Acronym / sponsor ID
- Pro00144202
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 31 Jul 2024 (actual)
- 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 World Health Organization Adult ADHD Self-Report Scale v1.1 (ASRS) is frequently used in family medicine clinics to screen for ADHD. Numerous studies have found the ASRS has a low positive predictive value. Compounding this concern is the format of the ASRS. Specifically, the answers on the ASRS that lead to screen positive results are shaded in gray and grouped together, which may make it easy for patients to discern which responses should be selected for a positive screen.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASRS without shading and with grouping | Experimental | Other: Altered ASRS format, without shading and with groupingThese 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). |
| ASRS with shading and without grouping | Experimental | Other: Altered ASRS format, with shading and without groupingThese 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). |
| ASRS without shading and without grouping | Experimental | Other: Altered ASRS format, without shading and without groupingThese 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). |
| Standard ASRS: with shading and with grouping | No intervention | –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). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| Altered ASRS format, without shading and with groupingParticipants will be asked to complete the ASRS form without shading and with grouping. | Other | ASRS without shading and with grouping |
| Altered ASRS format, with shading and without groupingParticipants will be asked to complete the ASRS form with shading and without grouping. | Other | ASRS with shading and without grouping |
| Altered ASRS format, without shading and without groupingParticipants will be asked to complete the ASRS form without shading and without grouping. | Other | ASRS without shading and without grouping |
Primary outcome
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.
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 13 Apr 2026.
- Results publication: PubMed 41551194Kraut RY, Ono C, Garrison S, Kamal O, Doroshuk ML, Vandermeer B, Amanna G, Babenko O. Does the format of the adult ADHD self-report scale influence screen-positive rates? A randomized controlled trial in primary care. Front Psychiatry. 2026 Jan 2;16:1646293. doi: 10.3389/fpsyt.2025.1646293. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Roni Kraut principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altered ASRS format, without shading and with grouping, Altered ASRS format, with shading and without grouping and Altered ASRS format, without shading and without grouping in people with Attention Deficit Hyperactivity Disorder, run by University of Alberta at 1 site in Canada.
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 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 13 Apr 2026. 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 Canada. 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?
Screen positive rate (time frame: Through study completion, estimated to be 2 months). 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 NCT06530758, which also lists 1 linked publication.
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 13 Apr 2026.