Preventing Addiction Related Suicide (PARS)

Substance-Related Disorders Clinical Trial

— PARS  

Official title:

Preventing Addiction Related Suicide (PARS) - Controlled Trial of Secondary Suicide Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166709
• Other study ID #: STUDY00001966
• Secondary ID: 1R01DA041486-01A
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: May 28, 2020

Study information

• Verified date: June 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance-Related Disorders
• Suicide

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Lakeside-Milam	Auburn	Washington
United States	Lakeside-Milam	Edmonds	Washington
United States	Evergreen Recovery Centers	Everett	Washington
United States	Lakeside-Milam	Everett	Washington
United States	Olalla Recovery Centers	Gig Harbor	Washington
United States	Lakeside-Milam	Issaquah	Washington
United States	Lakeside-Milam	Kirkland	Washington
United States	Northwest Integrated Health	Lakewood	Washington
United States	Evergreen Recovery Centers	Lynnwood	Washington
United States	Lakeside-Milam	Puyallup	Washington
United States	Northwest Integrated Health	Puyallup	Washington
United States	Lakeside-Milam	Renton	Washington
United States	Lakeside-Milam	Seattle	Washington
United States	THS	Seattle	Washington
United States	Lakeside-Milam	Tacoma	Washington
United States	Northwest Integrated Health	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PARS Behavior Scale	The PARS Behavior Scale assesses for help-seeking behavior of self and others.	Six months
Primary	PARS Suicide Knowledge Scale	The PARS Knowledge Scale assesses factual understanding of warning signs, triggers, and interventions for suicide.	Six months
Primary	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.	Six months
Secondary	Suicidal Behavior Questionnaire - Revised	The Suicidal Behavior Questionnaire - Revised assesses suicide attempts, ideation, communication, and intent since the last assessment.	Six months