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Preventing Addiction Related Suicide (PARS) (PARS)

Primary Purpose

Suicide, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preventing Addiction Related Suicide (PARS)
Intensive Outpatient Program standard session
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lakeside-Milam
  • Lakeside-Milam
  • Evergreen Recovery Centers
  • Lakeside-Milam
  • Olalla Recovery Centers
  • Lakeside-Milam
  • Lakeside-Milam
  • Northwest Integrated Health
  • Evergreen Recovery Centers
  • Lakeside-Milam
  • Northwest Integrated Health
  • Lakeside-Milam
  • Lakeside-Milam
  • THS
  • Lakeside-Milam
  • Northwest Integrated Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment As Usual

Experimental

Arm Description

Intensive Outpatient Program (IOP) addiction treatment

Secondary Prevention Intervention (PARS) plus Treatment as Usual

Outcomes

Primary Outcome Measures

PARS Behavior Scale
The PARS Behavior Scale assesses for help-seeking behavior of self and others.
PARS Suicide Knowledge Scale
The PARS Knowledge Scale assesses factual understanding of warning signs, triggers, and interventions for suicide.
PARS Attitude Scale
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

Suicidal Behavior Questionnaire - Revised
The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment.

Full Information

First Posted
May 22, 2017
Last Updated
June 30, 2020
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03166709
Brief Title
Preventing Addiction Related Suicide (PARS)
Acronym
PARS
Official Title
Preventing Addiction Related Suicide (PARS) - Controlled Trial of Secondary Suicide Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Studies consistently show suicide and suicidal behaviors are highly related to substance use disorders (SUDs). Recent reviews find that the risk of suicide is 10-17 times higher for people using multiple drugs, injecting drugs, and for alcohol use disorders. SUDs are also related to suicidal thoughts and suicide attempts. Clients admitted for alcohol treatment report a much higher rate of lifetime suicide attempts (40-43%) than a nationally representative sample of adults (4.6%). Further, prospective data shows that individuals in addiction treatment had five times the odds of suicide attempt over five years compared to those not in treatment, emphasizing addiction treatment as a key opportunity for instituting suicide prevention strategies. Based on Stage I guidelines for developing and adapting behavioral interventions and information from a Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Improvement Protocol (TIP50) on suicide and addiction, we developed the Preventing Addiction Related Suicide (PARS) program. To maximize the chances of implementation, PARS was developed to be a community-friendly program with a team of community partners (i.e., administrators, counselors, clients) who advised on its scope, duration, and approach. Community leaders reviewed PARS throughout its development and pilot testing was conducted in their community treatment settings. Thus, PARS is simultaneously based on evidence-based practice and the goals and needs of community treatment settings. Importantly, PARS is a selected prevention program and not intervention for suicidality per se-it is designed for all clients in addiction treatment as a standard part of care. PARS' goal is increased help-seeking by addiction treatment clients as well as by clients' friends and family if and when they themselves become suicidal. Reaching out for help leads to care that can address and resolve suicidality. PARS is the only published selected prevention program for this high-risk population. PARS is a psychoeducational program taught as a single three-hour module integrated into a standard group therapy-oriented Intensive Outpatient Program (IOP), the most common form of community addiction treatment. Pilot testing of PARS in three community agencies demonstrated significant post-intervention increases in accurate information about suicide and decreases in maladaptive attitudes toward suicide. These changes at post-intervention were maintained at 1-month follow-up. Even more compelling, 1-month follow-up assessments demonstrated that the likelihood of positive help seeking for suicidality doubled for the month after PARS compared to the month before. Clients were significantly more likely to ask suicidal friends (from 9% to 22%) and family (9% to 17%) to seek help as well as to seek help themselves (4% to 9%). Given these promising Stage I results in Stage III settings, we propose a fully-powered Stage III effectiveness trial of PARS compared to Treatment-as-Usual (TAU) using a stepped wedge design with 900 clients enrolled in 15 community addiction treatment sites. We will collect outcome data post-intervention and at 1, 3, and 6 months follow-up. We propose the following research aims: Aim 1: Compare the effectiveness of IOP integrating PARS to TAU to change beliefs about suicide and suicide prevention. Hypothesis 1a: Clients who receive PARS will know more accurate information about suicide. Hypothesis 1b: Clients who receive PARS will have less maladaptive attitudes about suicide. Aim 2: Compare the effectiveness of IOP integrating PARS to TAU to increase help-seeking behaviors for clients and for clients' friends or family at risk of suicide. Hypothesis 1c: Clients who receive PARS will show greater help-seeking for themselves and others Aim 3: Evaluate whether changes in beliefs about suicide and suicide prevention-particularly regarding warning signs for suicide, including addiction, intoxication, and relapse, as well as beliefs that suicide is preventable when action is taken-are possible mechanisms by which PARS increases help-seeking behavior. Hypothesis 2: The effect of PARS vs. TAU on changes in help-seeking will be mediated by improved information and attitudes. Exploratory Aim 4: Evaluate possible clinic-level dose effects of PARS administration such that participant outcomes improve the longer PARS is implemented within clinics. Exploratory Aim 5: Compare the effects of PARS vs. TAU on clients' suicidality and substance use in the follow-up period. By integrating PARS into IOP group treatment, community treatment agencies are in a unique position to act as key players in the national suicide prevention strategy by providing suicide prevention information, improving attitudes regarding suicide, and increasing help-seeking skills for one of the most high-risk populations for suicide. This proposal is innovative in its focus, the development of PARS in community settings, as well as the use of a stepped wedge design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Substance-Related Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
907 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Intensive Outpatient Program (IOP) addiction treatment
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Secondary Prevention Intervention (PARS) plus Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
Preventing Addiction Related Suicide (PARS)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Intensive Outpatient Program standard session
Intervention Description
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.
Primary Outcome Measure Information:
Title
PARS Behavior Scale
Description
The PARS Behavior Scale assesses for help-seeking behavior of self and others.
Time Frame
Six months
Title
PARS Suicide Knowledge Scale
Description
The PARS Knowledge Scale assesses factual understanding of warning signs, triggers, and interventions for suicide.
Time Frame
Six months
Title
PARS Attitude Scale
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Suicidal Behavior Questionnaire - Revised
Description
The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrolled client in one of the community treatment settings Over 18 years of age (no maximum age) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Anne Comtois, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeside-Milam
City
Auburn
State/Province
Washington
ZIP/Postal Code
98002
Country
United States
Facility Name
Lakeside-Milam
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Evergreen Recovery Centers
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Lakeside-Milam
City
Everett
State/Province
Washington
ZIP/Postal Code
98204
Country
United States
Facility Name
Olalla Recovery Centers
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Facility Name
Lakeside-Milam
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States
Facility Name
Lakeside-Milam
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Northwest Integrated Health
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Evergreen Recovery Centers
City
Lynnwood
State/Province
Washington
ZIP/Postal Code
98036
Country
United States
Facility Name
Lakeside-Milam
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98371
Country
United States
Facility Name
Northwest Integrated Health
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98374
Country
United States
Facility Name
Lakeside-Milam
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Lakeside-Milam
City
Seattle
State/Province
Washington
ZIP/Postal Code
98102
Country
United States
Facility Name
THS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Lakeside-Milam
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Northwest Integrated Health
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98406
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35385090
Citation
Ries RK, Livengood AL, Huh D, Kerbrat AH, Fruhbauerova M, Turner B, Comtois KA. Effectiveness of a Suicide Prevention Module for Adults in Substance Use Disorder Treatment: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e222945. doi: 10.1001/jamanetworkopen.2022.2945.
Results Reference
derived

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Preventing Addiction Related Suicide (PARS)

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