Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278922
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-17
Brief Title:
Evaluating Signs of Safety A Deaf-Accessible Therapy Toolkit for AUD and Trauma
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Evaluating Signs of Safety A Deaf-Accessible Therapy Toolkit for AUD and Trauma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The US Deaf community - a group of more than 500000 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
Detailed Description:
In partnership with Deaf-owned agency National Deaf Therapy the study team will conduct the first-ever full-scale psychotherapy trial conducted in the Deaf community - Evaluating Signs of Safety A Deaf-Accessible Therapy Toolkit for AUD and Trauma The US Deaf community - more than 500000 Americans who communicate using American Sign Language ASL - experiences nearly triple the rate of lifetime problem drinking compared to the general population 330 vs 123 and twice the rate of trauma exposure Among Deaf people in treatment for alcohol use disorder AUD 74 report lifetime physical emotional or sexual abuse and 44 report past-year abuse Comorbid AUDPTSD impairs multiple domains of functioning especially for Deaf individuals who show poorer functional outcomes than hearing individuals in socialization employment and physical health
Hearing individuals have access to several validated treatments for comorbid AUDPTSD yet there are no evidence-based treatments to treat any behavioral health condition with Deaf clients Available treatments fail to meet Deaf clients unique language access needs Deaf peoples median English literacy level falls at the fourth grade and health-related vocabulary among Deaf sign language users parallels non-English-speaking US immigrants Available treatment resources therefore require plain text revisions filmed ASL translations or education through storytelling to better match Deaf clients language needs
Leveraging extensive community engagement to address these barriers the Principal Investigators team of Deaf and hearing researchers clinicians filmmakers actors artists and Deaf people with AUDPTSD developed and pilot tested Signs of Safety a Deaf-accessible toolkit to be used with the Seeking Safety treatment protocol Seeking Safety is a manualized non-exposure-based cognitive behavioral therapy for trauma and addiction Among evidence-based treatments for AUDPTSD Seeking Safety is the optimal choice for Deaf clients - its focus on psychoeducation and simple coping skills is an ideal match for Deaf peoples language and literacy disparities which prohibit the use of narrative verbal problem-solving and cognitive processing strategies that other AUDPTSD therapies require Yet Seeking Safetys client materials rely on written English and are therefore not well understood by Deaf clients As such the Signs of Safety toolkit provides a supplemental therapist guide and population-specific client materials eg visual handouts filmed ASL teaching stories
Preliminary data from the Signs of Safety single-arm pilot and randomized feasibility pilot showed reductions in alcohol use frequency and PTSD severity from baseline to follow-up on the Reliable Change Index The delivery of the experimental intervention was deemed feasible by study therapists and was well-received by participants especially when moved to a virtual platform In response to the COVID-19 pandemic the study team overhauled in-person study methods to implement a virtual clinical trial - an acceleration of the inevitable development needed to scale Signs of Safety to a national level This adaptation also established a crucial collaboration with National Deaf Therapy NDT by far the nations largest provider of Deaf mental health services currently serving clients across 21 states This collaboration paired with comprehensive feasibility data the study team collected by testing a variety of virtual methods serves as the foundation of the study teams proposed aims
The study team will conduct a nationwide full-scale virtual clinical trial of Signs of Safety Leveraging the existing infrastructure and robust referral network of NDT the study team will enroll 144 Deaf adults with past-month PTSD and problem drinking Primary clinical outcomes at immediate post-treatment and post-treatment follow-up are past 30-day alcohol use frequencyquantity Alcohol Timeline Followback and past 30-day PTSD severity PTSD Checklist for DSM-5 Assessment will occur at baseline mid-treatment immediate post-treatment three-month post-treatment follow-up and six-month post-treatment follow-up Participants residing in states served by NDT n 96 will be randomized to receive either 1 a 12-session protocol of Seeking Safety Signs of Safety or 2 12 sessions of therapy as usual TAU general open-ended non-manualized supportive counseling provided by an NDT therapist The study team will enroll an additional 48 Deaf adults into a contemporaneous no-treatment control arm These individuals will be recruited from the existing NDT waitlist comprised of Deaf individuals residing in the states not yet served by NDT but voluntarily awaiting NDT services Additionally the study team will analyze potential moderators and mediators that lead to positive outcome Identified from the literatures on Seeking Safety alcohol treatment research and Deaf mental health research mechanisms of change are coping self-efficacy self-compassion motivation for treatment and access to health information
They study teams proposed aims build upon eight years of empirical work moving the program of research from Stage IB two-arm feasibility and pilot testing to Stage IIIII real world efficacy This clinical trial will potentially validate the first-ever evidence-based therapy for Deaf people as well as provide future behavioral health researchers with a vital roadmap for conducting community-engaged clinical trials with Deaf people
Hearing individuals have access to several validated treatments for comorbid AUDPTSD yet there are no evidence-based treatments to treat any behavioral health condition with Deaf clients Available treatments fail to meet Deaf clients unique language access needs Deaf peoples median English literacy level falls at the fourth grade and health-related vocabulary among Deaf sign language users parallels non-English-speaking US immigrants Available treatment resources therefore require plain text revisions filmed ASL translations or education through storytelling to better match Deaf clients language needs
Leveraging extensive community engagement to address these barriers the Principal Investigators team of Deaf and hearing researchers clinicians filmmakers actors artists and Deaf people with AUDPTSD developed and pilot tested Signs of Safety a Deaf-accessible toolkit to be used with the Seeking Safety treatment protocol Seeking Safety is a manualized non-exposure-based cognitive behavioral therapy for trauma and addiction Among evidence-based treatments for AUDPTSD Seeking Safety is the optimal choice for Deaf clients - its focus on psychoeducation and simple coping skills is an ideal match for Deaf peoples language and literacy disparities which prohibit the use of narrative verbal problem-solving and cognitive processing strategies that other AUDPTSD therapies require Yet Seeking Safetys client materials rely on written English and are therefore not well understood by Deaf clients As such the Signs of Safety toolkit provides a supplemental therapist guide and population-specific client materials eg visual handouts filmed ASL teaching stories
Preliminary data from the Signs of Safety single-arm pilot and randomized feasibility pilot showed reductions in alcohol use frequency and PTSD severity from baseline to follow-up on the Reliable Change Index The delivery of the experimental intervention was deemed feasible by study therapists and was well-received by participants especially when moved to a virtual platform In response to the COVID-19 pandemic the study team overhauled in-person study methods to implement a virtual clinical trial - an acceleration of the inevitable development needed to scale Signs of Safety to a national level This adaptation also established a crucial collaboration with National Deaf Therapy NDT by far the nations largest provider of Deaf mental health services currently serving clients across 21 states This collaboration paired with comprehensive feasibility data the study team collected by testing a variety of virtual methods serves as the foundation of the study teams proposed aims
The study team will conduct a nationwide full-scale virtual clinical trial of Signs of Safety Leveraging the existing infrastructure and robust referral network of NDT the study team will enroll 144 Deaf adults with past-month PTSD and problem drinking Primary clinical outcomes at immediate post-treatment and post-treatment follow-up are past 30-day alcohol use frequencyquantity Alcohol Timeline Followback and past 30-day PTSD severity PTSD Checklist for DSM-5 Assessment will occur at baseline mid-treatment immediate post-treatment three-month post-treatment follow-up and six-month post-treatment follow-up Participants residing in states served by NDT n 96 will be randomized to receive either 1 a 12-session protocol of Seeking Safety Signs of Safety or 2 12 sessions of therapy as usual TAU general open-ended non-manualized supportive counseling provided by an NDT therapist The study team will enroll an additional 48 Deaf adults into a contemporaneous no-treatment control arm These individuals will be recruited from the existing NDT waitlist comprised of Deaf individuals residing in the states not yet served by NDT but voluntarily awaiting NDT services Additionally the study team will analyze potential moderators and mediators that lead to positive outcome Identified from the literatures on Seeking Safety alcohol treatment research and Deaf mental health research mechanisms of change are coping self-efficacy self-compassion motivation for treatment and access to health information
They study teams proposed aims build upon eight years of empirical work moving the program of research from Stage IB two-arm feasibility and pilot testing to Stage IIIII real world efficacy This clinical trial will potentially validate the first-ever evidence-based therapy for Deaf people as well as provide future behavioral health researchers with a vital roadmap for conducting community-engaged clinical trials with Deaf people
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA031010 | NIH | None | httpsreporternihgovquickSearchR01AA031010 |