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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA041486-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual | Active Comparator | Intensive Outpatient Program (IOP) addiction treatment |
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| Experimental | Experimental | Secondary Prevention Intervention (PARS) plus Treatment as Usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventing Addiction Related Suicide (PARS) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Suicidal Behavior Questionnaire - Revised | The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment. Total score with higher indicating the worse outcome of suicide risk from lowest (3) to highest (18); non-clinical cutoff 7 and above | Six months |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Anne Comtois, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeside-Milam | Auburn | Washington | 98002 | United States | ||
| Lakeside-Milam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35385090 | Derived | 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. |
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Recruitment completed between October 2017 and September 2019
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 4 Months TAU, 20 Months PARS | Group 1: 90 day Intensive Outpatient Program - 4 months Treatment as Usual (Control Condition), 20 months PARS (Experimental Condition). |
| FG001 | Group 2: 8 Months TAU, Then 16 Months PARS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1 (Months 1-4) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2019 | Mar 17, 2024 |
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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.
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| Intensive Outpatient Program standard session | Behavioral | 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. |
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| Edmonds |
| Washington |
| 98026 |
| United States |
| Evergreen Recovery Centers | Everett | Washington | 98201 | United States |
| Lakeside-Milam | Everett | Washington | 98204 | United States |
| Olalla Recovery Centers | Gig Harbor | Washington | 98335 | United States |
| Lakeside-Milam | Issaquah | Washington | 98027 | United States |
| Lakeside-Milam | Kirkland | Washington | 98033 | United States |
| Northwest Integrated Health | Lakewood | Washington | 98499 | United States |
| Evergreen Recovery Centers | Lynnwood | Washington | 98036 | United States |
| Lakeside-Milam | Puyallup | Washington | 98371 | United States |
| Northwest Integrated Health | Puyallup | Washington | 98374 | United States |
| Lakeside-Milam | Renton | Washington | 98055 | United States |
| Lakeside-Milam | Seattle | Washington | 98102 | United States |
| THS | Seattle | Washington | 98104 | United States |
| Lakeside-Milam | Tacoma | Washington | 98405 | United States |
| Northwest Integrated Health | Tacoma | Washington | 98406 | United States |
Group 2: 90 day Intensive Outpatient Program - 8 months Treatment as Usual (Control Condition), 16 months PARS (Experimental Condition)
| FG002 | Group 3: 12 Months TAU,12months PARS | Group 3: 90 day Intensive Outpatient Program - 12 months Treatment as Usual (Control Condition), 12 months PARS (Experimental Condition) |
| FG003 | Group 4: 16 Months TAU, 8 Months PARS | Group 4: 90 day Intensive Outpatient Program - 8 months Treatment as Usual (Control Condition), 16 months PARS (Experimental Condition) |
| FG004 | Group 5: 20 Months TAU, 4 Months PARS | Group 5: 90 day Intensive Outpatient Program - 20 months Treatment as Usual (Control Condition), 4 months PARS (Experimental Condition) |
| COMPLETED |
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| NOT COMPLETED |
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| Step 2 (Months 5-8) |
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| Step 3 (Months 9-12) |
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| Step 4 (Months 13-16) |
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| Step 5 (Months 17-20) |
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| Step 6 (Months 21-24) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment As Usual | Intensive Outpatient Program (IOP) addiction treatment 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. |
| BG001 | Experimental | Secondary Prevention Intervention (PARS) plus Treatment as Usual 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 40 participants did not provide their age | Count of Participants | Participants |
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| Age, Continuous | 40 participants did not provide their age | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. Previous research demonstrated validity pre- and post-suicide training and test-retest reliability from baseline to post-treatment in the TAU condition ranged from 0.46-0.62. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| PARS Attitude Scale | The PARS Attitude Scale, also adapted from the Staff Suicide Prevention Survey (SSPS), consists of 6 items evaluating 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. Internal consistency based on the pilot sample was 0.73-0.97 and in this full sample was 0.59-0.73. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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 trial 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. Internal consistency based on the pilot sample was 0.82-0.87 and in this full sample was 0.52-0.76. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Missing data for 107 participants. | Posted | Mean | Standard Deviation | units on a scale | Six months |
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| Primary | 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. | Missing data from 95 participants | Posted | Mean | Standard Deviation | units on a scale | Six months |
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| Primary | 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. | Missing data for 121 participants. | Posted | Mean | Standard Deviation | units on a scale | Six months |
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| Secondary | Suicidal Behavior Questionnaire - Revised | The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment. Total score with higher indicating the worse outcome of suicide risk from lowest (3) to highest (18); non-clinical cutoff 7 and above | Intent-to-treat | Posted | Mean | Standard Deviation | units on a scale | Six months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment As Usual | Intensive Outpatient Program (IOP) addiction treatment 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. | 4 | 478 | 4 | 478 | 0 | 478 |
| EG001 | Experimental | Secondary Prevention Intervention (PARS) plus Treatment as Usual 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 | 1 | 428 | 1 | 428 | 0 | 428 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt, Psychiatric Hospitalization or Any Death | Injury, poisoning and procedural complications | Systematic Assessment | NIH definition of SAE |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Anne Comtois | Center for Suicide Prevention and Recovery, University of Washington | 206-744-1752 | uwcspar@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2016 | Jul 23, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Between 18 and 65 years |
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| >=65 years |
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| Men |
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| Transexual or Non-Conforming Transgender or nonconforming |
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| Unknown |
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