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Preventing Addiction Related Suicide (PARS) (PARS)

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ClinicalTrials.gov Identifier: NCT03166709
Recruitment Status : Completed
First Posted : May 25, 2017
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kate Comtois, University of Washington

Brief Summary:
The goal of this study is to evaluate the effectiveness and utility of the investigator's National Institute on Drug Abuse (NIDA) R21 developed "Preventing Addiction Related Suicide" (PARS) program by utilizing a novel stepped wedge design to evaluate PARS as a selected prevention program to increase help-seeking by clients in community addiction treatment.

Condition or disease Intervention/treatment Phase
Suicide Substance-Related Disorders Behavioral: Preventing Addiction Related Suicide (PARS) Behavioral: Intensive Outpatient Program standard session Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 907 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stepped wedge - 15 sites randomly divided into 5 groups which are then randomly ordered into 5 steps. Step 1 is all control. During steps 2-6 one group implements the experimental condition in assigned order until all groups are doing experimental condition.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Addiction Related Suicide (PARS) - Controlled Trial of Secondary Suicide Prevention
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : May 28, 2020
Actual Study Completion Date : May 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Treatment As Usual
Intensive Outpatient Program (IOP) addiction treatment
Behavioral: Intensive Outpatient Program standard session
Intensive Outpatient Program (IOP) substance abuse group session focused on depression, grief, or managing emotions. Site-specific session topic is what that IOP usually provides and was chosen by agency leads prior to start of study.

Experimental: Experimental
Secondary Prevention Intervention (PARS) plus Treatment as Usual
Behavioral: Preventing Addiction Related Suicide (PARS)
PARS is a module designed for a single session of an Intensive Outpatient Program (IOP) including a specified combination of didactic presentations and group discussions. PARS topics include: Goals and Objectives; Suicide Overview; The Strong Link Between Addiction and Suicide; Suicide Myths and Facts; Common Triggers of Suicidal Thoughts and Behaviors; Warning Signs of Suicide; Suicide Risk Factors; Suicide Protective Factors; How You Can Prevent Addiction Related Suicide; Action Steps to Take if You or Someone You Know Becomes Suicidal




Primary Outcome Measures :
  1. PARS Behavior Scale [ Time Frame: Six months ]
    The PARS Behavior Scale assesses for help-seeking behavior of self and others.

  2. PARS Suicide Knowledge Scale [ Time Frame: Six months ]
    The PARS Knowledge Scale assesses factual understanding of warning signs, triggers, and interventions for suicide.

  3. PARS Attitude Scale [ Time Frame: Six months ]
    The PARS Attitude Scale evaluates stigma and bias toward suicidal acts or persons, as well as perceptions that suicide is preventable if appropriate action is taken.


Secondary Outcome Measures :
  1. Suicidal Behavior Questionnaire - Revised [ Time Frame: Six months ]
    The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Enrolled client in one of the community treatment settings
  2. Over 18 years of age (no maximum age)
  3. Ability to understand written and spoken English

Exclusion Criteria:

1. Any clinical medical/psychiatric condition, severity of that condition, or life situation that in the opinion of the counselors or Drs. Comtois or Ries would compromise safe and voluntary study participation (e.g., psychosis, custody conflict). This is expected to be a rare circumstance and will be known prior to the recruitment session. If a counselor does not want someone involved, they will not be. If counselor is unsure, Dr. Comtois or Ries will facilitate decision with counselor ahead of time to assist in the decision.


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): NCT03166709


Locations
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United States, Washington
Lakeside-Milam
Auburn, Washington, United States, 98002
Lakeside-Milam
Edmonds, Washington, United States, 98026
Evergreen Recovery Centers
Everett, Washington, United States, 98201
Lakeside-Milam
Everett, Washington, United States, 98204
Olalla Recovery Centers
Gig Harbor, Washington, United States, 98335
Lakeside-Milam
Issaquah, Washington, United States, 98027
Lakeside-Milam
Kirkland, Washington, United States, 98033
Northwest Integrated Health
Lakewood, Washington, United States, 98499
Evergreen Recovery Centers
Lynnwood, Washington, United States, 98036
Lakeside-Milam
Puyallup, Washington, United States, 98371
Northwest Integrated Health
Puyallup, Washington, United States, 98374
Lakeside-Milam
Renton, Washington, United States, 98055
Lakeside-Milam
Seattle, Washington, United States, 98102
THS
Seattle, Washington, United States, 98104
Lakeside-Milam
Tacoma, Washington, United States, 98405
Northwest Integrated Health
Tacoma, Washington, United States, 98406
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Katherine Anne Comtois, PhD, MPH University of Washington
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Responsible Party: Kate Comtois, Professor, Dept of Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT03166709    
Other Study ID Numbers: STUDY00001966
1R01DA041486-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders