Trial Outcomes & Findings for Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma (NCT NCT03845985)
NCT ID: NCT03845985
Last Updated: 2024-03-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Change from baseline to immediate post-intervention at 12 weeks
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
Baseline characteristics by cohort
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=9 Participants
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.
|
Assessment-only Waitlist Control
n=7 Participants
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.67 years
STANDARD_DEVIATION 12.43 • n=99 Participants
|
42.71 years
STANDARD_DEVIATION 12.16 • n=107 Participants
|
43.81 years
STANDARD_DEVIATION 11.94 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
% Drinking Days per Month
|
40.37 percent drinking days per month
STANDARD_DEVIATION 47.74 • n=99 Participants
|
49.52 percent drinking days per month
STANDARD_DEVIATION 46.60 • n=107 Participants
|
44.38 percent drinking days per month
STANDARD_DEVIATION 45.89 • n=206 Participants
|
|
% Binge Drinking Days per Month
|
16.30 percent binge drinking days per month
STANDARD_DEVIATION 34.98 • n=99 Participants
|
1.43 percent binge drinking days per month
STANDARD_DEVIATION 2.62 • n=107 Participants
|
9.79 percent binge drinking days per month
STANDARD_DEVIATION 26.71 • n=206 Participants
|
|
Total # of Drinks per Month
|
57.89 drinks per month
STANDARD_DEVIATION 89.05 • n=99 Participants
|
42.80 drinks per month
STANDARD_DEVIATION 49.14 • n=107 Participants
|
51.29 drinks per month
STANDARD_DEVIATION 72.49 • n=206 Participants
|
|
Past 30-Day PTSD Severity Score
|
1.61 units on a scale
STANDARD_DEVIATION 0.76 • n=99 Participants
|
2.29 units on a scale
STANDARD_DEVIATION 0.68 • n=107 Participants
|
1.91 units on a scale
STANDARD_DEVIATION 0.78 • n=206 Participants
|
|
Brief Comprehensive Effects of Alcohol Score
Risk and Aggression/Liquid Courage/Sociability Subscale Score
|
2.32 units on a scale
STANDARD_DEVIATION 0.99 • n=99 Participants
|
2.67 units on a scale
STANDARD_DEVIATION 0.51 • n=107 Participants
|
2.49 units on a scale
STANDARD_DEVIATION 0.80 • n=206 Participants
|
|
Brief Comprehensive Effects of Alcohol Score
Self-Perception/Cognitive and Behavioral Impairment Subscale
|
1.92 units on a scale
STANDARD_DEVIATION 0.82 • n=99 Participants
|
2.68 units on a scale
STANDARD_DEVIATION 0.81 • n=107 Participants
|
2.25 units on a scale
STANDARD_DEVIATION 0.88 • n=206 Participants
|
|
Brief Comprehensive Effects of Alcohol Score
Sexuality Subscale
|
2.31 units on a scale
STANDARD_DEVIATION 1.44 • n=99 Participants
|
1.57 units on a scale
STANDARD_DEVIATION 0.61 • n=107 Participants
|
1.97 units on a scale
STANDARD_DEVIATION 1.16 • n=206 Participants
|
|
Brief Comprehensive Effects of Alcohol Score
Tension Reduction
|
3.22 units on a scale
STANDARD_DEVIATION 0.67 • n=99 Participants
|
2.93 units on a scale
STANDARD_DEVIATION 0.96 • n=107 Participants
|
3.09 units on a scale
STANDARD_DEVIATION 0.80 • n=206 Participants
|
|
Penn Alcohol Craving Scale Score
|
9.22 units on a scale
STANDARD_DEVIATION 7.85 • n=99 Participants
|
15.43 units on a scale
STANDARD_DEVIATION 3.36 • n=107 Participants
|
11.94 units on a scale
STANDARD_DEVIATION 6.89 • n=206 Participants
|
|
Trauma Symptom Checklist 40 Total Severity Score
|
0.81 units on a scale
STANDARD_DEVIATION 0.34 • n=99 Participants
|
1.47 units on a scale
STANDARD_DEVIATION 0.46 • n=107 Participants
|
1.10 units on a scale
STANDARD_DEVIATION 0.51 • n=206 Participants
|
|
BASIS-24 Total Severity Score
|
1.25 units on a scale
STANDARD_DEVIATION 0.44 • n=99 Participants
|
1.60 units on a scale
STANDARD_DEVIATION 0.44 • n=107 Participants
|
1.40 units on a scale
STANDARD_DEVIATION 0.46 • n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to immediate post-intervention at 12 weeksPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
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
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment
|
-20.00 percent drinking days per month
Standard Deviation 29.06
|
-11.11 percent drinking days per month
Standard Deviation 67.68
|
PRIMARY outcome
Timeframe: Change from baseline to one-month follow-up at 16 weeksPopulation: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.
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
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=2 Participants
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.
|
Assessment-only Waitlist Control
n=5 Participants
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.
|
|---|---|---|
|
Change From Baseline Percent Drinking Days Per Month at One-month Follow-up
|
-26.67 percent drinking days per month
Standard Deviation 37.71
|
-13.33 percent drinking days per month
Standard Deviation 27.99
|
PRIMARY outcome
Timeframe: Change from baseline to immediate post-intervention at 12 weeksPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
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
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment
|
17.78 percent binge drinking days per month
Standard Deviation 74.93
|
-0.56 percent binge drinking days per month
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: Change from baseline to one-month follow-up at 16 weeksPopulation: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.
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
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=2 Participants
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.
|
Assessment-only Waitlist Control
n=5 Participants
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.
|
|---|---|---|
|
Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up
|
-23.33 percent binge drinking days per month
Standard Deviation 33.00
|
-0.67 percent binge drinking days per month
Standard Deviation 1.49
|
PRIMARY outcome
Timeframe: Change from baseline to immediate post-intervention at 12 weeksPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
Change from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment
|
122.67 drinks per month
Standard Error 272.56
|
-9.17 drinks per month
Standard Error 40.12
|
PRIMARY outcome
Timeframe: Change from baseline to one-month follow-up at 16 weeksPopulation: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.
Change from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=2 Participants
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.
|
Assessment-only Waitlist Control
n=5 Participants
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.
|
|---|---|---|
|
Change From Baseline Number of Drinks Per Month at One-month Follow-up
|
-33.50 drinks per month
Standard Deviation 47.38
|
-22.90 drinks per month
Standard Deviation 28.04
|
PRIMARY outcome
Timeframe: Change from baseline to immediate post-intervention at 12 weeksPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5
|
-0.30 units on a scale
Standard Deviation 0.05
|
-0.53 units on a scale
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: Change from baseline to one-month follow-up at 16 weeksPopulation: Analysis includes only those participants who completed the one-month follow-up/16 week assessment.
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=1 Participants
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.
|
Assessment-only Waitlist Control
n=5 Participants
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.
|
|---|---|---|
|
Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5
|
-0.40 units on a scale
Standard Deviation NA
Only 1 participant analyzed in this arm for this outcome.
|
-0.22 units on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-upPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
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.
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
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|---|---|---|
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The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
Sexuality Subscale
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.95
|
|
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
Tension Reduction Subscale
|
1.83 units on a scale
Standard Deviation 0.58
|
-0.17 units on a scale
Standard Deviation 0.82
|
|
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
Risk and Aggression/Liquid Courage/Sociability Subscale
|
0.38 units on a scale
Standard Deviation 1.19
|
0.05 units on a scale
Standard Deviation 0.73
|
|
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
Self-Perception/Cognitive and Behavioral Impairment Subscale
|
-0.33 units on a scale
Standard Deviation 0.38
|
0.00 units on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-upPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
Total score = sum of all 5 items. Minimum = 0; Maximum = 30. Higher values indicate higher severity of alcohol craving.
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Penn Alcohol Craving Scale (PACS)
|
1.33 score on a scale
Standard Deviation 14.05
|
-4.83 score on a scale
Standard Deviation 7.62
|
SECONDARY outcome
Timeframe: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-upPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
Sum of all items divided by 40 items. Minimum = 0; Maximum = 3. Higher values indicate more severe trauma symptoms.
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=3 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Trauma Symptom Checklist - 40 (TSC-40)
|
-0.22 units on a scale
Standard Deviation 0.31
|
-0.15 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-upPopulation: Analysis includes only those participants who completed the immediate post-intervention/12 week assessment.
Sum of all items divided by 24 items. Minimum = 0; Maximum = 4. Higher values indicate worsening behavior or more severe behavioral health symptoms.
Outcome measures
| Measure |
Seeking Safety + Signs of Safety Toolkit
n=2 Participants
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.
|
Assessment-only Waitlist Control
n=6 Participants
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.
|
|---|---|---|
|
Behavior and Symptom Identification Scale - 24 (BASIS-24)
|
-0.16 units on a scale
Standard Deviation 0.65
|
.06 units on a scale
Standard Deviation 0.22
|
Adverse Events
Seeking Safety + Signs of Safety Toolkit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Assessment-only Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa L. Anderson, Associate Professor of Psychiatry
UMass Chan Medical School
Phone: 508-856-5820
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place