NCT03166709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
906

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 14, 2025

Completed
Last Updated

August 14, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

May 22, 2017

Results QC Date

March 17, 2024

Last Update Submit

July 24, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • PARS Help-Seeking Scale

    The PARS Help-Seeking Scale consists of 4 items assessing help-seeking behavior in the context of suicidal thoughts or feelings (e.g., calling a crisis/suicide hotline) developed for our pilot trial22 based on prior suicide prevention programs. Participants reported the frequency of past-month help-seeking on behalf of self or others, including friends and family members, from "never" (=0) to "more than 3 times" (=4). Responses were summed to create a score from 0 to 16 with higher numbers indicating the better outcome of increased help-seeking.

    Six months

  • PARS Suicide Knowledge Scale

    The PARS Suicide Knowledge Scale is an 11-item measure adapted from the Staff Suicide Prevention Survey (SSPS) assessing factual understanding of suicide and closely mapped to the content of PARS. Correct responses were summed to create a score from 0 to 11 with higher scores representing the better outcome of greater suicide knowledge.

    Six months

  • PARS Attitude Scale

    The PARS Attitude Scale, adapted from the Staff Suicide Prevention Survey (SSPS), consists of 6 items evaluating maladaptive attitudes about suicide stigma and prevention. Responses on a 5-point scale from "strongly disagree" (=1) to "strongly agree" (=5) were summed to create a score from 6 to 30 where lower scores indicate a better outcome.

    Six months

Secondary Outcomes (1)

  • Suicidal Behavior Questionnaire - Revised

    Six months

Study Arms (2)

Treatment As Usual

ACTIVE COMPARATOR

Intensive Outpatient Program (IOP) addiction treatment

Behavioral: Intensive Outpatient Program standard session

Experimental

EXPERIMENTAL

Secondary Prevention Intervention (PARS) plus Treatment as Usual

Behavioral: Preventing Addiction Related Suicide (PARS)

Interventions

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

Experimental

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.

Treatment As Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Lakeside-Milam

Auburn, Washington, 98002, United States

Location

Lakeside-Milam

Edmonds, Washington, 98026, United States

Location

Evergreen Recovery Centers

Everett, Washington, 98201, United States

Location

Lakeside-Milam

Everett, Washington, 98204, United States

Location

Olalla Recovery Centers

Gig Harbor, Washington, 98335, United States

Location

Lakeside-Milam

Issaquah, Washington, 98027, United States

Location

Lakeside-Milam

Kirkland, Washington, 98033, United States

Location

Northwest Integrated Health

Lakewood, Washington, 98499, United States

Location

Evergreen Recovery Centers

Lynnwood, Washington, 98036, United States

Location

Lakeside-Milam

Puyallup, Washington, 98371, United States

Location

Northwest Integrated Health

Puyallup, Washington, 98374, United States

Location

Lakeside-Milam

Renton, Washington, 98055, United States

Location

Lakeside-Milam

Seattle, Washington, 98102, United States

Location

THS

Seattle, Washington, 98104, United States

Location

Lakeside-Milam

Tacoma, Washington, 98405, United States

Location

Northwest Integrated Health

Tacoma, Washington, 98406, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SuicideSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Katherine Anne Comtois
Organization
Center for Suicide Prevention and Recovery, University of Washington

Study Officials

  • Katherine Anne Comtois, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dept of Psychology

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 25, 2017

Study Start

October 11, 2017

Primary Completion

May 28, 2020

Study Completion

May 28, 2020

Last Updated

August 14, 2025

Results First Posted

August 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations