Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 3:04 PM
Study NCT ID:
NCT05207956
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2021-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
App for Strengthening Services In Specialized Therapeutic Support
Sponsor:
Organization:
Raw JSON
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'7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Non-binary/ third gender', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Prefer not to disclose', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Work experience, Years', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '4.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-11', 'size': 295117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-11T09:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2021-11-24', 'resultsFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-04', 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Difference in Data Collection Consistency Between Groups Across Three Weeks', 'timeFrame': 'Three-week trial period', 'description': 'Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period. These metrics were captured via web analytics in partnership with our digital health company.'}, {'measure': 'The Difference in Data Collection Completion Between Groups Across Three Weeks', 'timeFrame': 'Three-week trial period', 'description': 'Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period. These metrics were captured via web analytics in partnership with our digital health company.'}, {'measure': 'The Difference in Data Collection Timeliness Between Groups Across Three Weeks', 'timeFrame': 'Three-week trial period', 'description': 'Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period. These metrics were captured via web analytics in partnership with our digital health company.'}], 'secondaryOutcomes': [{'measure': 'Intentions for Implementors', 'timeFrame': 'Assessed at baseline and end of 3-week trial period', 'description': 'We adapted scales to measure mechanisms affecting data collection, including intentions, using social psychology methods (Armitage \\& Connor, 2001). The intentions measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger intentions to take data. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.'}, {'measure': 'System Usability Scale', 'timeFrame': 'Three-week trial period', 'description': 'We used the System Usability Scale (SUS; Brooke, 1996) to measure aides\' reactions to various statements regarding the app\'s usability with 10 items that use a 5-point scale from (1) strongly disagree to (5) strongly agree. The SUS has high internal consistent reliability (Cronbach\'s alpha = .91) and demonstrated sensitivity to change (Lewis, 2018). We adapted the original questionnaire to replace "system" with "app" across all items. The SUS is calculated as a proportion score out of 100, with higher scores indicating higher usability (≥85 = Excellent; ≥71 = Good; ≥51 = Okay (Bangor et al.).'}, {'measure': 'Attitudes for Implementors', 'timeFrame': 'Assessed at baseline and end of 3-week trial period', 'description': 'We adapted scales to measure mechanisms affecting data collection, including attitudes, using social psychology methods (Armitage \\& Connor, 2001). The attitudes measure had one item, which was rated from 1=good to 7=bad (meaning that taking data would be bad). Attitudes had 2 items. These items were averaged to create the scale score which could range from 1 to 7 for each measure. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.'}, {'measure': 'Perceived Norms for Implementors', 'timeFrame': 'Assessed at baseline and end of 3-week trial period', 'description': 'We adapted scales to measure mechanisms affecting data collection, including perceived norms, using social psychology methods (Armitage \\& Connor, 2001). The perceived norms measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger influence of norms on taking data. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.'}, {'measure': 'Descriptive Norms for Implementors', 'timeFrame': 'Assessed at baseline and end of 3-week trial period', 'description': 'We adapted scales to measure mechanisms affecting data collection, including descriptive norms, using social psychology methods (Armitage \\& Connor, 2001). The perceived norms measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger influence of norms on taking data. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.'}, {'measure': 'Self-Efficacy for Implementors', 'timeFrame': 'Assessed at baseline and end of 3-week trial period', 'description': 'We adapted scales to measure mechanisms affecting data collection, including self-efficacy, using social psychology methods (Armitage \\& Connor, 2001). The self-efficacy measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger self-efficacy about taking data. Self-Efficacy had 2 items. These items were averaged to create the scale score which could range from 1 to 7 for each measure. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Data collection', 'autism', 'Behavioral Health Technician (BHT)', 'behavioral economics', 'implementation', 'implementation strategy', 'implementation science', 'Therapeutic Support Staff (TSS)'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': "In partnership with a digital health software company, the University research team created two versions of a mobile application to help behavioral health technicians (BHT's) who work with students with autism collect data. The first version comprises a basic electronic platform for data collection. The second version has the same basic electronic platform for data collection, plus additional features designed to increase motivation to collect data and ease the burden of data collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be working as a paraprofessionals or behavioral health technicians\n* Currently providing individual support to children with autism\n* Currently providing services in Philadelphia preschools, schools, day cares, or homes.\n\nExclusion Criteria:\n\n* n/a'}, 'identificationModule': {'nctId': 'NCT05207956', 'acronym': 'ASSISTS', 'briefTitle': 'App for Strengthening Services In Specialized Therapeutic Support', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'App for Strengthening Services In Specialized Therapeutic Support', 'orgStudyIdInfo': {'id': '849995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Electronic Platform', 'description': 'A basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection.', 'interventionNames': ['Behavioral: Behavioral economics strategies', 'Other: Electronic platform']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electronic Platform Not Enhanced', 'description': 'A basic electronic platform for data collection.', 'interventionNames': ['Other: Electronic platform']}], 'interventions': [{'name': 'Behavioral economics strategies', 'type': 'BEHAVIORAL', 'description': 'Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.', 'armGroupLabels': ['Enhanced Electronic Platform']}, {'name': 'Electronic platform', 'type': 'OTHER', 'description': 'Electronic platform to collect data', 'armGroupLabels': ['Electronic Platform Not Enhanced', 'Enhanced Electronic Platform']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}