protocolSection identificationModule nctId: NCT06278922, orgStudyIdInfo id: STUDY00001149, secondaryIdInfos id: R01AA031010, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031010, briefTitle: Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2028-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The U.S. Deaf community - a group of more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome., conditionsModule conditions: PTSD, conditions: Alcohol; Use, Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The PI and all Co-Is will be masked to study condition., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Seeking Safety + Signs of Safety toolkit, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Number of Drinks Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Number of Drinks Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Number of Drinks Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5, primaryOutcomes measure: Change from Baseline Past 30-day PTSD Severity to Three-month Follow-up as Measured by the PCL-5, primaryOutcomes measure: Change from Baseline Past 30-day PTSD Severity to Six-month Follow-up as Measured by the PCL-5, secondaryOutcomes measure: Change from Baseline Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for Alcohol Use Disorder to Immediate Post-Treatment as measured by the DSM-5 AUD Assessment Tool, secondaryOutcomes measure: Change from Baseline Percent Days of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Number of Instances of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Percent Days of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Number of Instances of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Percent Days of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Number of Instances of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Substance-related Problems at Immediate Post-Treatment as Measured by the Short Inventory of Problems Revised (SIPS-R), secondaryOutcomes measure: Change from Baseline Alcohol Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Drug Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Marijuana Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Tobacco Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Psychosocial Functioning at Immediate Post-Treatment as Measured by the Outcome Questionnaire (OQ-30.2) for Adults, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-16, uploadDate: 2024-02-16T10:27, filename: Prot_SAP_000.pdf, size: 2163767, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-08-21, uploadDate: 2024-02-16T10:29, filename: ICF_001.pdf, size: 85664, hasResults: False