Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06705205
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short, Animated Storytelling (SAS) for Addiction Stigma Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Addiction Stigma Scale Score as measured by the Attribution Questionnaire (AQ)', 'timeFrame': 'Immediately post-intervention on Day 1 and after two weeks', 'description': 'Participants complete an 18-item shortened version of the validated AQ. The AQ-18 will be scored along a 9-point Likert scale indicating the extent to which participants agree with the item ranging from "not at all" to "very much" with a maximum score of 27 for each 3-item construct. Higher scores indicate greater stigma.'}], 'secondaryOutcomes': [{'measure': 'Change in Optimism Scale Score', 'timeFrame': 'Immediately post-intervention on Day 1 and after two weeks', 'description': 'Participants complete the Brief García\'s Interactive Optimism Scale (BIOS-G). The BIOS-G is an instrument designed to assess an individual\'s level of general optimism towards their life and other people. The scale includes 4 statements for which respondents indicate their level of agreement from 1 ("Of course not") to 4 ("Yes, of course"). Higher scores indicate a greater level of optimism.'}, {'measure': 'Change in Attitude Thermometer Score', 'timeFrame': 'Immediately post-intervention on Day 1 and after two weeks', 'description': 'Participants will indicate their warmth towards subject using a self-report stigma thermometer. Using a scale scores from zero to 100, with higher scores indicating more empathy or more favorable attitudes.'}, {'measure': 'Change in Levels of Hope using a visual analogue scale (VAS)', 'timeFrame': 'Immediately post-intervention on Day 1 and after two weeks', 'description': 'Participants self-report levels of hope using a VAS, a longstanding, validated tool for assessing related constructs of stress and subjective well-being. The scale goes from zero to 100 and higher scores indicate higher levels of hope.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Stigma Towards People With Addiction']}, 'referencesModule': {'references': [{'pmid': '40324168', 'type': 'DERIVED', 'citation': 'Adam M, Klapow M, Greuel M, Seeff M, Rohr JK, Gordon A, Amsalem D, Barnighausen T. Short, Animated Storytelling Video to Reduce Addiction Stigma in 13,500 Participants Across Multiple Countries Through an Online Approach: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 5;14:e73382. doi: 10.2196/73382.'}]}, 'descriptionModule': {'briefSummary': 'Stigma towards people with addiction is a well-documented problem that negatively impacts help-seeking, treatment and recovery. Social contact with people recovering from addiction can promote empathy and reduce stigma, but social contact is difficult to scale. Short, animated storytelling (SAS) is a novel health communication approach that scales easily because it can leapfrog barriers associated with language, culture, literacy and education levels. This study will investigate if a SAS video intervention can be used to reduce stigma, boost optimism and hope, and increasing empathy towards people with addiction. The study will also explore mechanisms of action of SAS interventions, by measuring the contribution of sound design to the effect of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with basic English proficiency between the ages of 18-49\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06705205', 'acronym': 'SAS', 'briefTitle': 'Short, Animated Storytelling (SAS) for Addiction Stigma Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Short, Animated Storytelling Video to Reduce Addiction Stigma: Protocol for a Multi-country, Online, Randomized, Controlled Trial With 13,500 Participants', 'orgStudyIdInfo': {'id': '76457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAS video full intervention group', 'description': 'Participants view the full SAS video intervention with sound on Day 1.', 'interventionNames': ['Other: SAS video']}, {'type': 'EXPERIMENTAL', 'label': 'SAS video partial intervention (without sound)', 'description': 'Participants view the partial SAS video intervention without sound on Day 1.', 'interventionNames': ['Other: SAS video']}, {'type': 'NO_INTERVENTION', 'label': 'Active Control Group', 'description': 'Participants read written information about addiction prevalence'}], 'interventions': [{'name': 'SAS video', 'type': 'OTHER', 'otherNames': ['short animated storytelling video'], 'description': 'The intervention is a short, animated storytelling video, with soundtrack, aimed at reducing addiction stigma.', 'armGroupLabels': ['SAS video full intervention group', 'SAS video partial intervention (without sound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Maya Adam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'All data will be made available via the Stanford Medicine Research Repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexander von Humboldt Association', 'class': 'OTHER'}, {'name': 'Stanford Center for Digital Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor of Pediatrics', 'investigatorFullName': 'Maya Adam', 'investigatorAffiliation': 'Stanford University'}}}}