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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03845985
Enrollment
16
Registered
2019-02-19
Start date
2019-06-03
Completion date
2022-07-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Post Traumatic Stress Disorder

Keywords

psychotherapy, trauma, addiction, Deaf

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.

Detailed description

The U.S. Deaf community - 500,000+ Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking compared to the general population and twice the rate of trauma exposure. Although there are validated treatments for comorbid alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments to treat any behavioral health condition with Deaf clients. Current treatments fail to meet Deaf clients' unique linguistic and cultural needs. Deaf people's median English reading level falls at the fourth grade, and many have low health literacy due to reduced incidental learning (e.g., inability to communicate with hearing parents, overhear family conversations, or understand spoken health information on TV/radio/public service announcements). Written treatment materials, therefore, require plain text revisions, ASL translations, or ASL narrative storytelling. Equally important are materials that incorporate Deaf values and social norms, increasing clinicians' cultural competence and enhancing client engagement. To address these barriers, the Principal Investigator conducted a pilot study to develop a prototype of Signs of Safety: a Deaf-accessible toolkit to be used alongside a widely-disseminated protocol for addiction/PTSD - Seeking Safety. Seeking Safety has demonstrated efficacy for reduction of AUD and PTSD symptoms in hearing populations. Among available evidence-based protocols, Seeking Safety is the optimal choice to adapt for Deaf clients - its focus on simple coping skills that simultaneously target AUD and PTSD (or either alone) is an ideal match for Deaf people's language and learning deficits, which prohibit use of verbal problem-solving and cognitive processing strategies that other psychotherapies require. Yet, Seeking Safety's client materials rely on written English and are not well understood by Deaf clients. As such, the Signs of Safety 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. Data from the Principal Investigator's Signs of Safety single-arm pilot study (n = 13) show significant reductions in alcohol use frequency and PTSD severity from baseline to immediate post-treatment follow-up. Participants also reported high levels of satisfaction with the model, and provided detailed feedback about how to further improve Signs of Safety for a professional-quality, second iteration. The proposed study builds upon the Principal Investigator's pilot work by generating a final, professional iteration of Signs of Safety to be used in future efficacy work. Based on pilot results, the study team created a second iteration of the Signs of Safety toolkit, including re-filming ASL teaching stories, re-designing visual handouts, and revising the therapist companion guide. The study team will then develop a training program for Signs of Safety and certify four study clinicians. The study team proposes to conduct a two-arm pilot RCT of Signs of Safety. The study team aims to enroll 60 Deaf adults with past-month PTSD and past-month alcohol consumption to participate in 12 weekly individual treatment sessions. The pilot RCT will compare the 12-session protocol of Seeking Safety + Signs of Safety toolkit with an assessment-only waitlist control. Across conditions, assessment will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. The study team will analyze key aspects of feasibility for both study arms (e.g., recruitment, retention, assessment process). Primary clinical outcomes at immediate post-treatment and one-month follow-up are past 30-day alcohol use frequency/quantity and past 30-day PTSD severity. Exploratory analyses will be conducted to examine potential moderators and mediators of change (e.g., motivation for treatment, provider cultural competency, coping skills, self-compassion, understanding of health information) leading to positive outcome. Results from this study will produce feasibility and preliminary efficacy data to support for a full-scale RCT to evaluate Signs of Safety, and a community-engaged model for conducting RCTs with Deaf participants.

Interventions

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Self-identification as a Deaf ASL user * Age 18 or older * Past-month alcohol consumption, as measured by the Alcohol Use Disorder Identification Test * 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.)

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5Change from baseline to one-month follow-up at 16 weeksTotal Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-upChange from baseline to one-month follow-up at 16 weeksChange from baseline percent binge drinking days per month (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
Change From Baseline Number of Drinks Per Month at Immediate Post-TreatmentChange from baseline to immediate post-intervention at 12 weeksChange from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Number of Drinks Per Month at One-month Follow-upChange from baseline to one-month follow-up at 16 weeksChange from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5Change from baseline to immediate post-intervention at 12 weeksTotal Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Change From Baseline Percent Drinking Days Per Month at Immediate Post-TreatmentChange from baseline to immediate post-intervention at 12 weeksChange from baseline percent drinking days per month (i.e., days with 1+ drink) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Percent Drinking Days Per Month at One-month Follow-upChange from baseline to one-month follow-up at 16 weeksChange from baseline percent drinking days per month (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-TreatmentChange from baseline to immediate post-intervention at 12 weeksChange from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback

Secondary

MeasureTime frameDescription
Penn Alcohol Craving Scale (PACS)Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-upTotal score = sum of all 5 items. Minimum = 0; Maximum = 30. Higher values indicate higher severity of alcohol craving.
Trauma Symptom Checklist - 40 (TSC-40)Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-upSum of all items divided by 40 items. Minimum = 0; Maximum = 3. Higher values indicate more severe trauma symptoms.
Behavior and Symptom Identification Scale - 24 (BASIS-24)Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-upSum of all items divided by 24 items. Minimum = 0; Maximum = 4. Higher values indicate worsening behavior or more severe behavioral health symptoms.
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-upAll four subscales: Min. = 1, Max. = 4. Risk and Aggression/Liquid Courage/Sociability Subscale: Higher values indicate greater outcome expectancies of drinking alcohol on risk-taking, aggression, courage, and sociability. Self-Perception/Cognitive and Behavioral Impairment Subscale: Higher values indicate greater outcome expectancies on distorted self-perception and impaired behavior. Sexuality Subscale: Higher values indicate greater outcome expectancies on sexual behavior. Tension Reduction Subscale: Higher values indicate greater outcome expectancies on tension reduction.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
9
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.
7
Total16

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up21
Overall StudyPhysician Decision10
Overall StudyWithdrawal by Subject41

Baseline characteristics

CharacteristicAssessment-only Waitlist ControlSeeking Safety + Signs of Safety ToolkitTotal
Age, Continuous42.71 years
STANDARD_DEVIATION 12.16
44.67 years
STANDARD_DEVIATION 12.43
43.81 years
STANDARD_DEVIATION 11.94
BASIS-24 Total Severity Score1.60 units on a scale
STANDARD_DEVIATION 0.44
1.25 units on a scale
STANDARD_DEVIATION 0.44
1.40 units on a scale
STANDARD_DEVIATION 0.46
% Binge Drinking Days per Month1.43 percent binge drinking days per month
STANDARD_DEVIATION 2.62
16.30 percent binge drinking days per month
STANDARD_DEVIATION 34.98
9.79 percent binge drinking days per month
STANDARD_DEVIATION 26.71
Brief Comprehensive Effects of Alcohol Score
Risk and Aggression/Liquid Courage/Sociability Subscale Score
2.67 units on a scale
STANDARD_DEVIATION 0.51
2.32 units on a scale
STANDARD_DEVIATION 0.99
2.49 units on a scale
STANDARD_DEVIATION 0.8
Brief Comprehensive Effects of Alcohol Score
Self-Perception/Cognitive and Behavioral Impairment Subscale
2.68 units on a scale
STANDARD_DEVIATION 0.81
1.92 units on a scale
STANDARD_DEVIATION 0.82
2.25 units on a scale
STANDARD_DEVIATION 0.88
Brief Comprehensive Effects of Alcohol Score
Sexuality Subscale
1.57 units on a scale
STANDARD_DEVIATION 0.61
2.31 units on a scale
STANDARD_DEVIATION 1.44
1.97 units on a scale
STANDARD_DEVIATION 1.16
Brief Comprehensive Effects of Alcohol Score
Tension Reduction
2.93 units on a scale
STANDARD_DEVIATION 0.96
3.22 units on a scale
STANDARD_DEVIATION 0.67
3.09 units on a scale
STANDARD_DEVIATION 0.8
% Drinking Days per Month49.52 percent drinking days per month
STANDARD_DEVIATION 46.6
40.37 percent drinking days per month
STANDARD_DEVIATION 47.74
44.38 percent drinking days per month
STANDARD_DEVIATION 45.89
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants6 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Past 30-Day PTSD Severity Score2.29 units on a scale
STANDARD_DEVIATION 0.68
1.61 units on a scale
STANDARD_DEVIATION 0.76
1.91 units on a scale
STANDARD_DEVIATION 0.78
Penn Alcohol Craving Scale Score15.43 units on a scale
STANDARD_DEVIATION 3.36
9.22 units on a scale
STANDARD_DEVIATION 7.85
11.94 units on a scale
STANDARD_DEVIATION 6.89
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants8 Participants15 Participants
Sex: Female, Male
Female
5 Participants6 Participants11 Participants
Sex: Female, Male
Male
2 Participants3 Participants5 Participants
Total # of Drinks per Month42.80 drinks per month
STANDARD_DEVIATION 49.14
57.89 drinks per month
STANDARD_DEVIATION 89.05
51.29 drinks per month
STANDARD_DEVIATION 72.49
Trauma Symptom Checklist 40 Total Severity Score1.47 units on a scale
STANDARD_DEVIATION 0.46
0.81 units on a scale
STANDARD_DEVIATION 0.34
1.10 units on a scale
STANDARD_DEVIATION 0.51

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 7
other
Total, other adverse events
0 / 90 / 7
serious
Total, serious adverse events
0 / 90 / 7

Outcome results

Primary

Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment

Change from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback

Time frame: Change from baseline to immediate post-intervention at 12 weeks

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Number of Drinks Per Month at Immediate Post-Treatment122.67 drinks per monthStandard Error 272.56
Assessment-only Waitlist ControlChange From Baseline Number of Drinks Per Month at Immediate Post-Treatment-9.17 drinks per monthStandard Error 40.12
p-value: 0.491t-test, 2 sided
Primary

Change From Baseline Number of Drinks Per Month at One-month Follow-up

Change from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

Time frame: Change from baseline to one-month follow-up at 16 weeks

Population: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Number of Drinks Per Month at One-month Follow-up-33.50 drinks per monthStandard Deviation 47.38
Assessment-only Waitlist ControlChange From Baseline Number of Drinks Per Month at One-month Follow-up-22.90 drinks per monthStandard Deviation 28.04
p-value: 0.715t-test, 2 sided
Primary

Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5

Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.

Time frame: Change from baseline to one-month follow-up at 16 weeks

Population: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5-0.40 units on a scale
Assessment-only Waitlist ControlChange From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5-0.22 units on a scaleStandard Deviation 0.98
p-value: 0.875t-test, 2 sided
Primary

Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5

Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.

Time frame: Change from baseline to immediate post-intervention at 12 weeks

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5-0.30 units on a scaleStandard Deviation 0.05
Assessment-only Waitlist ControlChange From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5-0.53 units on a scaleStandard Deviation 0.86
p-value: 0.665t-test, 2 sided
Primary

Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment

Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback

Time frame: Change from baseline to immediate post-intervention at 12 weeks

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment17.78 percent binge drinking days per monthStandard Deviation 74.93
Assessment-only Waitlist ControlChange From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment-0.56 percent binge drinking days per monthStandard Deviation 1.36
p-value: 0.713t-test, 2 sided
Primary

Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up

Change from baseline percent binge drinking days per month (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

Time frame: Change from baseline to one-month follow-up at 16 weeks

Population: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up-23.33 percent binge drinking days per monthStandard Deviation 33
Assessment-only Waitlist ControlChange From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up-0.67 percent binge drinking days per monthStandard Deviation 1.49
p-value: 0.509t-test, 2 sided
Primary

Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment

Change from baseline percent drinking days per month (i.e., days with 1+ drink) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback

Time frame: Change from baseline to immediate post-intervention at 12 weeks

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment-20.00 percent drinking days per monthStandard Deviation 29.06
Assessment-only Waitlist ControlChange From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment-11.11 percent drinking days per monthStandard Deviation 67.68
p-value: 0.838t-test, 2 sided
Primary

Change From Baseline Percent Drinking Days Per Month at One-month Follow-up

Change from baseline percent drinking days per month (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

Time frame: Change from baseline to one-month follow-up at 16 weeks

Population: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitChange From Baseline Percent Drinking Days Per Month at One-month Follow-up-26.67 percent drinking days per monthStandard Deviation 37.71
Assessment-only Waitlist ControlChange From Baseline Percent Drinking Days Per Month at One-month Follow-up-13.33 percent drinking days per monthStandard Deviation 27.99
p-value: 0.62t-test, 2 sided
Secondary

Behavior and Symptom Identification Scale - 24 (BASIS-24)

Sum of all items divided by 24 items. Minimum = 0; Maximum = 4. Higher values indicate worsening behavior or more severe behavioral health symptoms.

Time frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitBehavior and Symptom Identification Scale - 24 (BASIS-24)-0.16 units on a scaleStandard Deviation 0.65
Assessment-only Waitlist ControlBehavior and Symptom Identification Scale - 24 (BASIS-24).06 units on a scaleStandard Deviation 0.22
p-value: 0.709t-test, 2 sided
Secondary

Penn Alcohol Craving Scale (PACS)

Total score = sum of all 5 items. Minimum = 0; Maximum = 30. Higher values indicate higher severity of alcohol craving.

Time frame: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitPenn Alcohol Craving Scale (PACS)1.33 score on a scaleStandard Deviation 14.05
Assessment-only Waitlist ControlPenn Alcohol Craving Scale (PACS)-4.83 score on a scaleStandard Deviation 7.62
p-value: 0.407t-test, 2 sided
Secondary

The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)

All four subscales: Min. = 1, Max. = 4. Risk and Aggression/Liquid Courage/Sociability Subscale: Higher values indicate greater outcome expectancies of drinking alcohol on risk-taking, aggression, courage, and sociability. Self-Perception/Cognitive and Behavioral Impairment Subscale: Higher values indicate greater outcome expectancies on distorted self-perception and impaired behavior. Sexuality Subscale: Higher values indicate greater outcome expectancies on sexual behavior. Tension Reduction Subscale: Higher values indicate greater outcome expectancies on tension reduction.

Time frame: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Risk and Aggression/Liquid Courage/Sociability Subscale0.38 units on a scaleStandard Deviation 1.19
Seeking Safety + Signs of Safety ToolkitThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Self-Perception/Cognitive and Behavioral Impairment Subscale-0.33 units on a scaleStandard Deviation 0.38
Seeking Safety + Signs of Safety ToolkitThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Sexuality Subscale0.00 units on a scaleStandard Deviation 0
Seeking Safety + Signs of Safety ToolkitThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Tension Reduction Subscale1.83 units on a scaleStandard Deviation 0.58
Assessment-only Waitlist ControlThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Tension Reduction Subscale-0.17 units on a scaleStandard Deviation 0.82
Assessment-only Waitlist ControlThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Risk and Aggression/Liquid Courage/Sociability Subscale0.05 units on a scaleStandard Deviation 0.73
Assessment-only Waitlist ControlThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Sexuality Subscale0.00 units on a scaleStandard Deviation 0.95
Assessment-only Waitlist ControlThe Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)Self-Perception/Cognitive and Behavioral Impairment Subscale0.00 units on a scaleStandard Deviation 1.18
Comparison: Comparison of the Risk and Aggression/Liquid Courage/Sociability Subscalep-value: 0.61t-test, 2 sided
Comparison: Comparison of the Self-Perception/Cognitive and Behavioral Impairment Subscalep-value: 0.658t-test, 2 sided
Comparison: Comparison of the Sexuality Subscalep-value: 1t-test, 2 sided
Comparison: Comparison of the Tension Reduction Subscalep-value: 0.007t-test, 2 sided
Secondary

Trauma Symptom Checklist - 40 (TSC-40)

Sum of all items divided by 40 items. Minimum = 0; Maximum = 3. Higher values indicate more severe trauma symptoms.

Time frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up

Population: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.

ArmMeasureValue (MEAN)Dispersion
Seeking Safety + Signs of Safety ToolkitTrauma Symptom Checklist - 40 (TSC-40)-0.22 units on a scaleStandard Deviation 0.31
Assessment-only Waitlist ControlTrauma Symptom Checklist - 40 (TSC-40)-0.15 units on a scaleStandard Deviation 0.83
p-value: 0.893t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026