nctId: NCT06278922 id: STUDY00001149 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 overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2028-09-30 date: 2028-09-30 date: 2024-02-26 date: 2024-02-26 name: University of Massachusetts, Worcester class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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. conditions: PTSD conditions: Alcohol; Use, Problem studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The PI and all Co-Is will be masked to study condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Seeking Safety + Signs of Safety toolkit name: Treatment as usual measure: Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5 measure: Change from Baseline Past 30-day PTSD Severity to Three-month Follow-up as Measured by the PCL-5 measure: Change from Baseline Past 30-day PTSD Severity to Six-month Follow-up as Measured by the PCL-5 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 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 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 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 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 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 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 measure: Change from Baseline Substance-related Problems at Immediate Post-Treatment as Measured by the Short Inventory of Problems Revised (SIPS-R) measure: Change from Baseline Alcohol Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Drug Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Marijuana Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Tobacco Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Psychosocial Functioning at Immediate Post-Treatment as Measured by the Outcome Questionnaire (OQ-30.2) for Adults sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT 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 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