Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT06291233
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-30
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interview TIME: Training Inspired Minds for Employment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Competitive Employment based on self-report employment surveys', 'timeFrame': 'Approximately 9 months after randomization', 'description': 'Self-report employment surveys completed. Employment will be tracked as 0 (no job) and 1 (job). Higher scores indicate a better outcome.'}, {'measure': 'Change in Job Interview Skills from Mock Interview Rating Scale (MIRS)', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'Interviewing skills will be measured using a role-play measure in which subjects act out two job interview scenarios with trained actors. Interviews will be video recorded and scored. There is one pre-test score and one post-test score. There are 15 questions on a scale from 1 to 7 (scores range from 15 to 105), with higher scores indicating a better outcome (better interview skills).'}, {'measure': 'Time to Employment', 'timeFrame': 'Approximately 9 months after randomization', 'description': 'The number of days between randomization and obtaining employment using a questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Change in Interview Anxiety using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA)', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'This is a 13 item self-report using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA). After reviewing the brief PRSPA, the study team selected and reframed 13 items using a three-point Likert-type scale (0 = "not at all," 1 = "sometimes," and 2 = "often"). Higher scores indicated higher anxiety, and scores could range from 0 to 26.'}, {'measure': 'Change in Interview Motivation', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'This is a 10 item self-report using a five-point Likert scale (1 = Not at all true, 5 = Very true). Higher scores indicate higher job interview motivation, a better outcome, and scores range from 10 to 50)'}, {'measure': 'Change in Work Readiness using the Work Readiness Scale (WRS)', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'Change in work readiness using the Work Readiness Scale (WRS) which is a 13 item self-report using a five-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree) with higher scores indicating a higher readiness to work, a positive outcome. Scores range from 13 to 65.'}, {'measure': 'Change in Work Motivation using the Work Motivation Scale (WMS)', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'Change in work motivation using the Work Motivation Scale (WMS) which is a 12-item self-report using a four-point Likert scale (1 = Disagree to 4 = Strongly Agree) with higher scores indicating a higher motivation to work, a better outcome. Scores range from 13 to 52.'}, {'measure': 'Change in Social Cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A)', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'Change in social cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A). There are 21 videos shown to participants and are scored as either correct (1) or incorrect (0). A total score is provided and can range from 0 to 21, with higher scores indicating a higher social cognition ability, a better outcome.'}, {'measure': 'Change in Interview Knowledge', 'timeFrame': 'Pre-Test (baseline), post-test (approximately 6 weeks)', 'description': 'Change in interview knowledge by using a 10-item survey designed to assess basic knowledge about job interviews. There are multiple choice questions, and answers are marked as either correct (1) or incorrect (0). Higher scores indicate better interview knowledge, a positive outcome. Scores range from 0 to 10.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Job interview skills', 'Students'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.\n\nParticipants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group).', 'detailedDescription': 'Participants will have assessments that will be done over the computer or in-person at school or program site. Assessments will be about participants background, employment history, mood and feelings, autistic traits, memory, mental health issues, such as depression and anxiety, and other things. Some assessments will be audio and/or video recorded.\n\nPlease note that there will be teachers and staff consented (approximately n=32) to deliver the intervention, however, will not count for the clinical trial. Therefore, the information will not be added to the anticipated enrollment numbers in study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants have a diagnosis on the autism spectrum\n* Participants are enrolled in pre-employment transition services\n* Participants have at least a third-grade reading level\n* Are unemployed or employed and job-seeking\n\nExclusion Criteria:\n\n\\- Not enrolled in pre-employment transition services'}, 'identificationModule': {'nctId': 'NCT06291233', 'briefTitle': 'Interview TIME: Training Inspired Minds for Employment', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Hybrid Effectiveness-Implementation RCT of Virtual Interview Training for Autistic Transition-Age Youth', 'orgStudyIdInfo': {'id': 'HUM00236812'}, 'secondaryIdInfos': [{'id': '1R01MH132656-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH132656-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Interview Training', 'interventionNames': ['Behavioral: Virtual Interview Training (VIT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Services-as-usual', 'interventionNames': ['Behavioral: Services-as-usual']}], 'interventions': [{'name': 'Virtual Interview Training (VIT)', 'type': 'BEHAVIORAL', 'description': 'Teachers will administer the intervention (Virtual Interview Training) with the student participants. University of Michigan research staff will train all teachers (including sites in California) and will provide support as necessary throughout the intervention delivery process. Surveys will be captures several times throughout delivery as delivery is expected to be anywhere between 4 to 6 weeks long.', 'armGroupLabels': ['Virtual Interview Training']}, {'name': 'Services-as-usual', 'type': 'BEHAVIORAL', 'description': "Participants will receive services-as-usual at participants school or program for approximately 6 weeks. Those that are in the active control group will receive access to the e-learning content of the Rita/Travis intervention (not the practice interviews) and will be able to review the e-learning content with teacher's supervision. In addition, this group will review a series of video conversations with autistic adults about navigating the pathway to a career. Surveys will be collected at different time points after randomization.", 'armGroupLabels': ['Services-as-usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92054', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Classical Academy', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92054', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Outside the Lens', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92110', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Transition Resources for Adult Community Education', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92182', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'The Institute for Effective Education', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92182', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'The San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91977', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Mount Miguel High School', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Urban Autism Solutions', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ann Arbor Academy', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48357', 'city': 'Highland', 'state': 'Michigan', 'country': 'United States', 'facility': 'Milford High School', 'geoPoint': {'lat': 42.63809, 'lon': -83.61717}}, {'zip': '48146', 'city': 'Lincoln Park', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lincoln Park', 'geoPoint': {'lat': 42.25059, 'lon': -83.17854}}, {'zip': '48383', 'city': 'White Lake', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland High School', 'geoPoint': {'lat': 42.6917, 'lon': -83.55411}}, {'zip': '07936-3147', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'zip': '07424', 'city': 'Little Falls', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Banyan High School', 'geoPoint': {'lat': 40.86899, 'lon': -74.2082}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Alpine Learning Group', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}], 'overallOfficials': [{'name': 'Matthew Smith', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': "The data will be made available within 6 months of the study's conclusion and will remain available for at least 5 years.", 'ipdSharing': 'YES', 'description': "Survey data from the randomized control trial (RCT) participants will be deposited into the National Institute of Mental Health (NIMH) Data Archive repository. This will include basic demographic information and self reported data from validated measures that can be found within the NIMH Data Archive Repository's data dictionaries. Identifiable information will not be available for access.", 'accessCriteria': 'According to the NIMH Data Archive Repository, researchers who want to access the data may create a username and password and submit a Data Access Request for permission to access the data. Please see the following website for more details: https://nda.nih.gov/nda/access-data-info'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Matthew Smith', 'investigatorAffiliation': 'University of Michigan'}}}}