Clinical trial NCT03166709: Preventing Addiction Related Suicide (PARS)
Official title: Preventing Addiction Related Suicide (PARS) - Controlled Trial of Secondary Suicide Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Substance-Related Disorders
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-05-25
Enrollment: 907
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: PARS Behavior Scale
timeFrame: Six months
measure: PARS Suicide Knowledge Scale
timeFrame: Six months
measure: PARS Attitude Scale
timeFrame: Six months
Secondary outcomes:
measure: Suicidal Behavior Questionnaire - Revised
timeFrame: Six months
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Lakeside-Milam
state: Washington
city: Edmonds
country: United States
facility: Lakeside-Milam
state: Washington
city: Everett
country: United States
facility: Evergreen Recovery Centers
state: Washington
city: Everett
country: United States
facility: Lakeside-Milam
state: Washington
city: Gig Harbor
country: United States
facility: Olalla Recovery Centers
state: Washington
city: Issaquah
country: United States
facility: Lakeside-Milam
state: Washington
city: Kirkland
country: United States
facility: Lakeside-Milam
state: Washington
city: Lakewood
country: United States
facility: Northwest Integrated Health
state: Washington
city: Lynnwood
country: United States
facility: Evergreen Recovery Centers
state: Washington
city: Puyallup
country: United States
facility: Lakeside-Milam
state: Washington
city: Puyallup
country: United States
facility: Northwest Integrated Health
state: Washington
city: Renton
country: United States
facility: Lakeside-Milam
state: Washington
city: Seattle
country: United States
facility: Lakeside-Milam
state: Washington
city: Seattle
country: United States
facility: THS
state: Washington
city: Tacoma
country: United States
facility: Lakeside-Milam
state: Washington
city: Tacoma
country: United States
facility: Northwest Integrated Health
state: Washington
Study officials:
affiliation: University of Washington
name: Katherine Anne Comtois, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.