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Evaluating "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

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ClinicalTrials.gov Identifier: NCT03845985
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Melissa L. Anderson, University of Massachusetts, Worcester

Brief Summary:
The U.S. Deaf community - 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 as compared to the general population. Although there are validated treatments for alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments for any behavioral health condition that have been validated for use with Deaf clients. To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The study team's ongoing aims are to conduct a two-arm pilot RCT of "Signs of Safety" and to collect data on feasibility, preliminary clinical outcomes, and potential mediators and moderators of outcome.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Post Traumatic Stress Disorder Behavioral: Seeking Safety + Signs of Safety toolkit Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants will be randomly assigned to one of two conditions: (1) Seeking Safety + Signs of Safety toolkit, or (2) assessment-only waitlist control. Randomization will occur within each study site and stratified by gender. The Biostatistician will generate a computerized random number series and place numbers in individual sealed opaque envelopes. The RC will open an envelope to randomly assign a treatment condition to the participant. Both the PI and Co-I/Outcomes Assessor will be blind to study condition. (Note: the Co-I/Outcomes Assessor will remain blind to study condition until the end of the post-treatment assessment, at which point she will administer a client satisfaction measure that will unblind the Co-I to which subjects are in the waitlist control group.)
Primary Purpose: Treatment
Official Title: Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Seeking Safety + Signs of Safety toolkit
Participants randomized to receive the intervention will be provided 12 one-hour weekly individual treatment sessions with one of four ASL-fluent study clinicians in Massachusetts. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16.
Behavioral: Seeking Safety + Signs of Safety toolkit

Seeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., "Coping with Triggers," "Asking for Help").

"Signs of Safety" is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters.


No Intervention: Assessment-only Waitlist Control
Participants randomized to the waitlist control condition will be offered the opportunity to receive the 12-session Seeking Safety + Signs of Safety toolkit intervention after an approximate 16 week waiting period. This 16 week waiting period is equivalent to the current waitlist to receive psychotherapy services through the PI's outpatient clinic. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16.



Primary Outcome Measures :
  1. Change from Baseline Percent Drinking Days Per Week at Immediate Post-Treatment [ Time Frame: Change from baseline to immediate post-intervention at 12 weeks ]
    Change from baseline percent drinking days per week (i.e., days with 1+ drink) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback

  2. Change from Baseline Percent Drinking Days Per Week at One-month Follow-up [ Time Frame: Change from baseline to one-month follow-up at 16 weeks ]
    Change from baseline percent drinking days per week (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

  3. Change from Baseline Percent Binge Drinking Days Per Week at Immediate Post-Treatment [ Time Frame: Change from baseline to immediate post-intervention at 12 weeks ]
    Change from baseline percent binge drinking days per week (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback

  4. Change from Baseline Percent Binge Drinking Days Per Week at One-month Follow-up [ Time Frame: Change from baseline to one-month follow-up at 16 weeks ]
    Change from baseline percent binge drinking days per week (i.e., days with 5+ drinks for men, 4+ for women) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

  5. Change from Baseline Mean Number of Drinking Days Per Week at Immediate Post-Treatment [ Time Frame: Change from baseline to immediate post-intervention at 12 weeks ]
    Change from baseline mean number of drinking days per week at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback

  6. Change from Baseline Mean Number of Drinking Days Per Week at One-month Follow-up [ Time Frame: Change from baseline to one-month follow-up at 16 weeks ]
    Change from baseline mean number of drinking days per week at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

  7. Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5 [ Time Frame: Change from baseline to immediate post-intervention at 12 weeks ]
    PTSD Checklist for DSM-5 (PCL-5) is a 20-item measure of DSM-5 PTSD symptoms that is reliably used to monitor symptom change.

  8. Change from Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5 [ Time Frame: Change from baseline to one-month follow-up at 16 weeks ]
    PTSD Checklist for DSM-5 (PCL-5) is a 20-item measure of DSM-5 PTSD symptoms that is reliably used to monitor symptom change.


Secondary Outcome Measures :
  1. The Brief Comprehensive Effects of Alcohol questionnaire (B-CEOA) [ Time Frame: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up ]
    The Brief Comprehensive Effects of Alcohol questionnaire (B-CEOA) is a 15-item measure of positive and negative expectancy and valuations of various possible consequences of drinking. Respondents indicate their degree of agreement that an effect will likely occur if they drink, using a 1-4 scale (1 = disagree, 4 = agree). The B-CEOA questionnaire comprise a reduced four-scale model, as follows: (1) Risk and Aggression/Liquid Courage/Sociability, (2) Self-Perception/Cognitive and Behavioral Impairment, (3) Sexuality, and (4) Tension Reduction. The score for each scale is calculated by averaging the item scores, i.e., totaling the item scores and dividing by the number of items in the scale. The range of scores for each of the four scales are 1-4. Higher scores indicate more agreement.

  2. Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up ]
    The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6. Higher scores indicate greater alcohol cravings.

  3. Alcohol Use Disorder Identification Test (AUDIT) [ Time Frame: Screening ]
    The AUDIT is a 10-item screening tool to assess problematic alcohol consumption, drinking behaviors, and alcohol-related problems. A total score of 8 or more indicates harmful drinking behavior.

  4. Trauma Symptom Checklist - 40 (TSC-40) [ Time Frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up ]
    The TSC-40 is a 40-item measure of the long-term effects of complex trauma. Respondents are asked to rate how often they have experienced each symptom in the last two months using a 4-point frequency rating scale ranging from 0 ("never") to 3 ("often"). In addition to yielding a total score (ranging from 0 to 120), the TSC-40 has six subscales: Anxiety, Depression, Dissociation, Sexual Abuse Trauma Index, Sexual Problems, and Sleep Disturbances.The score for each subscale is the sum of the relevant items. Higher scores indicate higher trauma symptoms.

  5. Behavior and Symptom Identification Scale - 24 (BASIS-24) [ Time Frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up ]
    The Behavior and Symptom Identification Scale - 24 (BASIS-24) is a 24-item measure of psychiatric and substance-related symptoms and level of functioning. The 24 questions are scored on a 5-point scale (from 0 to 4) and each subscale and overall mean scores also range from 0 to 4, with 0 being the lowest severity of symptoms and 4 being the highest severity of symptoms. The overall BASIS-24 score is a weighted sum that is computed by multiplying the rating for each question by its weight and totaling the weighted ratings for each question. The score for each subscale is a weighted sum that is computed by multiplying the rating for each question in the subscale by its weight and totaling the weighted ratings for all questions in the subscale. The six subscales for the following domains of psychiatric and substance abuse symptoms and functioning include: Depression and Functioning, Relationships, Self-Harm, Emotional Lability, Psychosis, and Substance Abuse.

  6. Coping Skills as Assessed by the Coping Self-Efficacy Scale [ Time Frame: Baseline/Pre-Intervention, Week 4, Week 8, Week 12/Post-Intervention, Week 16/One-month Follow-up ]
    The Coping Self-Efficacy Scale is a 26-item measure of perceived ability to cope with past-month challenges. Respondents are asked to rate on an 11-point scale the extent to which they believe they could perform behaviors important to adaptive coping. Anchor points on the scale are 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). A total score is created by summing the item ratings.

  7. Self-Compassion Scale - Short Form [ Time Frame: Baseline/Pre-Intervention, Week 4, Week 8, Week 12/Intervention, Week 16/One-month Follow-up ]
    The Self-Compassion Scale - Short Form is a 12-item measure of self-compassion in instances of perceived failure, inadequacy, or suffering. It includes six subscales: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Over-identified. Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, note the reverse scores (the negative subscale items - self-judgment, isolation, and over-identification)- then compute a total mean.

  8. Understanding Health Information as Assessed by Ask, Understand, Remember Assessment (AURA) [ Time Frame: Baseline/Pre-Intervention, Week 4, Week 8, Week 12/Post-Intervention, Week 16/One-month Follow-up ]
    The AURA is a 4-item measure of one's ability to obtain, understand, and remember health information communicated by a provider. Respondents are asked if they agree or disagree with the 4 statements using a 4-point scale (1-disagree a lot, 2-disagree a little, 3-agree a little, 4-agree a lot). Scores range from 4-16 with higher scores indicating a more positive outcome.

  9. Motivation for Treatment for Individuals with Alcohol Use Disorder as Assessed by Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A) [ Time Frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up ]
    The SOCRATES 8A is a 19-item measure assessing readiness for change among individuals with Alcohol Use Disorder. Respondents rate the level of agreement or disagreement on a scale of 1 (strongly disagree) to 5 (strongly agree). The instrument yields three factorially-derived scale scores: Recognition (scores range 7-35), Ambivalence (scores range 4-20), and Taking Steps (scores range 8-40). Higher scores indicate more positive outcomes.

  10. Client-Reported Healthcare Provider Cultural Competency [ Time Frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up ]
    The Healthcare Provider Cultural Competency is a 9-item measure rating a provider's ability to interact with patients from one's cultural group. All nine items are answered using appropriately labeled 7-point scales ranging from 1 (Not at all) to 7 (Knows a lot). A combined cultural competency score is calculated by summing together scores for the items.


Other Outcome Measures:
  1. Client Satisfaction with Treatment Sessions as Assessed by Seeking Safety End of Session Questionnaire [ Time Frame: Weeks 1 - 12 ]
    Participants in the intervention group will complete a questionnaire at the end of each weekly therapy session to assess level of helpfulness and satisfaction with the session. The questionnaire includes four questions (e.g., How helpful was today's session for you?) that are rated on a 4-point scale from 0 (Not at all) to 3 (A great deal), and two open-ended questions for comments and feedback on the session. Scores range from 0-12, with higher scores indicating greater satisfaction with the session.

  2. Client Feedback on Intervention as Assessed by Seeking Safety End of Treatment Questionnaire at week 12 [ Time Frame: Week 12 ]
    Participants in the intervention group will complete a questionnaire after completing the intervention to assess level of helpfulness and satisfaction with the treatment overall. The questionnaire uses a 7-point rating scale from -3 (Greatly harmful) to 0 (Neutral) to 3 (Greatly helpful) for questions regarding the helpfulness of the treatment and includes open-ended questions for feedback and comments.

  3. Client Satisfaction with Intervention as Assessed by the Client Satisfaction Questionnaire (CSQ-8) at 12 weeks [ Time Frame: Week 12 ]
    The Client Satisfaction Questionnaire (CSQ-8) is an 8-item instrument used to assess general client satisfaction levels regarding a service. Items are rated on a 4-point scale. Scores are summed across items. Items B, D, E, and H are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

  4. Therapist Fidelity as Assessed by "Signs of Safety" Fidelity Scale [ Time Frame: Weeks 4, 8, 12 ]
    All intervention sessions will be videotaped, with 25% (3 sessions per participant) rated for fidelity on an ongoing basis by the Fidelity Consultant. One tape will be randomly selected from sessions 1 - 4; one from 5 - 8; and one from 9 - 12. The session tapes will be rated using the "Signs of Safety" Fidelity Scale to assess therapist integrity with regards to the following domains: (1) Focus on Deaf experience, (2) Comparison of Deaf and hearing people's recovery, (3) Communication access, (4) Validation of Deaf experience, (5) Respect for Deaf culture, (6) Attention to body language, and (7) Attention to language. Questions are rated on a 4-point scale with higher scores indicating greater integrity and fidelity.

  5. Therapist Adherence to Intervention as Assessed by Seeking Safety Adherence Scale [ Time Frame: Weeks 4, 8, 12 ]
    All intervention sessions will be videotaped, with 25% (3 sessions per participant) rated for adherence on an ongoing basis by the Fidelity Consultant. One tape will be randomly selected from sessions 1 - 4; one from 5 - 8; and one from 9 - 12. The session tapes will be rated using the Seeking Safety Adherence Scale to assess adherence in three domains: (1) Format (e.g., did they clinician follow the session structure of Seeking Safety?), (2) Content (e.g., Did the clinician use the Seeking Safety content?), (3) Process (e.g., Did the clinician use strong general clinical skills?). Questions are rated on a 4-point scale with higher scores indicating greater adherence to the intervention.

  6. Participant Adherence to Intervention [ Time Frame: Post-Intervention at Week 12 ]
    Participant Adherence will be measured using the number of sessions completed, comprehension of session content, and rates of participants' treatment enactment (i.e., completing "homework" between sessions).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identification as a Deaf ASL user
  • Age 18 or older
  • Problematic alcohol consumption, drinking behaviors, and alcohol-related problems (past-month referent time period; Alcohol Use Disorder Identification Test score ≥ 8 for men or ≥ 6 for women)
  • Subthreshold or full PTSD on the PTSD Checklist for DSM-5 (past-month referent time period; "subthreshold" = endorsement of at least two B-E criteria at a severity of "moderate" or higher)
  • Ability to attend weekly study sessions at one of three study locations (Eastern, Central, or Western MA)
  • Ability to access a videophone (the standard telecommunication device for the Deaf community)

Exclusion Criteria:

  • Participation in concurrent therapies (Note: Participants in both study conditions will be asked to refrain from concurrent formal psychotherapy; however, aligning with the Seeking Safety model, AA/NA/DRA attendance will be encouraged and attendance will be tracked as a potential outcome mediator).
  • Members of the following special populations: Adults unable to consent; Individuals younger than 18; Prisoners; Pregnant women (Note: We will not knowingly include pregnant women as participants; however, we will not assess participants' pregnancy status.)

Exclusion criteria are intentionally minimal to recruit a diverse sample. Other behavioral health comorbidities (e.g., mood/anxiety disorders, substance use disorders other than AUD) will not be excluded, given high rates of comorbidity.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845985


Contacts
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Contact: Emma G Pici-D'Ottavio, BA 508-856-8276 emma.picidottavio@umassmed.edu
Contact: Melissa L Anderson, PhD 508-856-5820 melissa.anderson@umassmed.edu

Locations
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United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Melissa L Anderson, PhD         
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Melissa L Anderson, PhD University of Massachusetts, Worcester
  Study Documents (Full-Text)

Documents provided by Melissa L. Anderson, University of Massachusetts, Worcester:

Publications:
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Responsible Party: Melissa L. Anderson, Psychologist and Clinical Researcher, Assistant Professor of Psychiatry, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03845985     History of Changes
Other Study ID Numbers: H00016364
R34AA026929 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data after deidentification that underlie the reported results (text, tables, figures, and appendices) will be available beginning 9 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by an independent review committee may use the data for individual participant data meta-analysis. Proposals may be submitted up to 36 months follow article publication. Please contact the Principal Investigator for information regarding submitting proposals and accessing data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available beginning 9 months and ending 36 months following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee may use the data for individual participant data meta-analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melissa L. Anderson, University of Massachusetts, Worcester:
psychotherapy
trauma
addiction
Deaf

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Alcohol Drinking
Alcoholism
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders