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Preventing Addiction Related Suicide (PARS)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03166709
Acronym
PARS
Enrollment
906
Registered
2017-05-25
Start date
2017-10-11
Completion date
2020-05-28
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-Related Disorders, Suicide

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.

Interventions

BEHAVIORALPreventing 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

BEHAVIORALIntensive 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
PARS Help-Seeking ScaleSix monthsThe 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.
PARS Suicide Knowledge ScaleSix monthsThe 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.
PARS Attitude ScaleSix monthsThe 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.

Secondary

MeasureTime frameDescription
Suicidal Behavior Questionnaire - RevisedSix monthsThe 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

Countries

United States

Participant flow

Recruitment details

Recruitment completed between October 2017 and September 2019

Participants by arm

ArmCount
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.
478
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
428
Total906

Baseline characteristics

CharacteristicTreatment As UsualExperimentalTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants5 Participants10 Participants
Age, Categorical
Between 18 and 65 years
445 Participants411 Participants856 Participants
Age, Continuous37.3 years
STANDARD_DEVIATION 12.4
37.7 years
STANDARD_DEVIATION 11.7
37.5 years
STANDARD_DEVIATION 12
Ethnicity (NIH/OMB)
Hispanic or Latino
31 Participants42 Participants73 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
439 Participants378 Participants817 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants8 Participants16 Participants
PARS Attitude Scale12.81 units on a scale
STANDARD_DEVIATION 3.25
12.58 units on a scale
STANDARD_DEVIATION 3.38
12.70 units on a scale
STANDARD_DEVIATION 3.32
PARS Help-Seeking Scale0.63 units on a scale
STANDARD_DEVIATION 1.45
0.48 units on a scale
STANDARD_DEVIATION 1.14
0.56 units on a scale
STANDARD_DEVIATION 1.32
PARS Suicide Knowledge Scale7.42 units on a scale
STANDARD_DEVIATION 1.68
7.76 units on a scale
STANDARD_DEVIATION 1.7
7.58 units on a scale
STANDARD_DEVIATION 1.69
Race (NIH/OMB)
American Indian or Alaska Native
16 Participants10 Participants26 Participants
Race (NIH/OMB)
Asian
11 Participants7 Participants18 Participants
Race (NIH/OMB)
Black or African American
16 Participants17 Participants33 Participants
Race (NIH/OMB)
More than one race
62 Participants46 Participants108 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants20 Participants40 Participants
Race (NIH/OMB)
White
347 Participants326 Participants673 Participants
Region of Enrollment
United States
478 participants428 participants906 participants
Sex/Gender, Customized
Men
269 Participants271 Participants540 Participants
Sex/Gender, Customized
Transexual or Non-Conforming Transgender or nonconforming
2 Participants2 Participants4 Participants
Sex/Gender, Customized
Unknown
6 Participants6 Participants12 Participants
Sex/Gender, Customized
Women
201 Participants149 Participants350 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 4781 / 428
other
Total, other adverse events
0 / 4780 / 428
serious
Total, serious adverse events
4 / 4781 / 428

Outcome results

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.

Time frame: Six months

Population: Missing data for 121 participants.

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualPARS Attitude Scale12.29 units on a scaleStandard Deviation 3.6
ExperimentalPARS Attitude Scale11.14 units on a scaleStandard Deviation 3.88
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.

Time frame: Six months

Population: Missing data for 107 participants.

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualPARS Help-Seeking Scale0.57 units on a scaleStandard Deviation 1.54
ExperimentalPARS Help-Seeking Scale0.53 units on a scaleStandard Deviation 1.66
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.

Time frame: Six months

Population: Missing data from 95 participants

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualPARS Suicide Knowledge Scale7.47 units on a scaleStandard Deviation 1.89
ExperimentalPARS Suicide Knowledge Scale8.24 units on a scaleStandard Deviation 1.83
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

Time frame: Six months

Population: Intent-to-treat

ArmMeasureValue (MEAN)Dispersion
Treatment As UsualSuicidal Behavior Questionnaire - Revised4.54 units on a scaleStandard Deviation 2.19
ExperimentalSuicidal Behavior Questionnaire - Revised4.82 units on a scaleStandard Deviation 2.41

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026