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Behavioral Intervention

Seeking Safety + Signs of Safety toolkit for Alcoholism

N/A
Waitlist Available
Led By Melissa L Anderson, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/pre-intervention, week 4, week 8, week 12/post-intervention, and week 16/one-month follow-up
Awards & highlights

Study Summary

This study is evaluating whether a new therapy toolkit may help improve alcohol use disorder and post-traumatic stress disorder for individuals who are deaf.

Eligible Conditions
  • Alcoholism
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/pre-intervention, week 4, week 8, week 12/post-intervention, and week 16/one-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/pre-intervention, week 4, week 8, week 12/post-intervention, and week 16/one-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment
Change From Baseline Number of Drinks Per Month at One-month Follow-up
Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5
+5 more
Secondary outcome measures
Behavior and Symptom Identification Scale - 24 (BASIS-24)
Penn Alcohol Craving Scale (PACS)
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
+1 more
Other outcome measures
Client Feedback on Intervention as Assessed by Seeking Safety End of Treatment Questionnaire at week 12
Client Satisfaction with Intervention as Assessed by the Client Satisfaction Questionnaire (CSQ-8) at 12 weeks
Client Satisfaction with Treatment Sessions as Assessed by Seeking Safety End of Session Questionnaire
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Seeking Safety + Signs of Safety toolkitExperimental Treatment1 Intervention
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.
Group II: Assessment-only Waitlist ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seeking Safety + Signs of Safety toolkit
2019
N/A
~20

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
342 Previous Clinical Trials
976,594 Total Patients Enrolled
9 Trials studying Alcoholism
2,981 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,495 Total Patients Enrolled
422 Trials studying Alcoholism
985,192 Patients Enrolled for Alcoholism
Melissa L Anderson, PhDPrincipal InvestigatorUniversity of Massachusetts, Worcester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
Melissa L. Anderson 2019. "Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03845985.
~3 spots leftby Apr 2025
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