Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-22 @ 7:45 PM
Study NCT ID:
NCT06530758
Status:
COMPLETED
Last Update Posted:
2024-12-30
First Post:
2024-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Format of the Adult ADHD Self-Report Scale Impact the Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 587}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screen positive rate', 'timeFrame': 'Through study completion, estimated to be 2 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 - 65 years old\n* Patients who are registering for their appointment at the family medicine clinic\n* Patients who are expected to be in the reception area for ≥5 minutes before going to a clinic room\n\nExclusion Criteria:\n\n* 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)'}, 'identificationModule': {'nctId': 'NCT06530758', 'briefTitle': 'Does the Format of the Adult ADHD Self-Report Scale Impact the Results', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Does the Format of the Adult ADHD Self-Report Scale Impact the Results: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pro00144202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASRS without shading and with grouping', 'description': '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).', 'interventionNames': ['Other: Altered ASRS format, without shading and with grouping']}, {'type': 'EXPERIMENTAL', 'label': 'ASRS with shading and without grouping', 'description': '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).', 'interventionNames': ['Other: Altered ASRS format, with shading and without grouping']}, {'type': 'EXPERIMENTAL', 'label': 'ASRS without shading and without grouping', 'description': '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).', 'interventionNames': ['Other: Altered ASRS format, without shading and without grouping']}, {'type': 'NO_INTERVENTION', 'label': 'Standard ASRS: with shading and with grouping', 'description': '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).'}], 'interventions': [{'name': 'Altered ASRS format, without shading and with grouping', 'type': 'OTHER', 'description': 'Participants will be asked to complete the ASRS form without shading and with grouping.', 'armGroupLabels': ['ASRS without shading and with grouping']}, {'name': 'Altered ASRS format, with shading and without grouping', 'type': 'OTHER', 'description': 'Participants will be asked to complete the ASRS form with shading and without grouping.', 'armGroupLabels': ['ASRS with shading and without grouping']}, {'name': 'Altered ASRS format, without shading and without grouping', 'type': 'OTHER', 'description': 'Participants will be asked to complete the ASRS form without shading and without grouping.', 'armGroupLabels': ['ASRS without shading and without grouping']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Shifa Medical Clinic', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Roni Kraut', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}