Substance-Related Disorders, Suicide
Conditions
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
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 (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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| PARS Help-Seeking Scale | Six months | 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. |
| PARS Suicide Knowledge Scale | Six months | 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. |
| PARS Attitude Scale | Six months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicidal Behavior Questionnaire - Revised | Six months | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment completed between October 2017 and September 2019
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 906 |
Baseline characteristics
| Characteristic | Treatment As Usual | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 445 Participants | 411 Participants | 856 Participants |
| Age, Continuous | 37.3 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 Participants | 42 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 439 Participants | 378 Participants | 817 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 16 Participants |
| PARS Attitude Scale | 12.81 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 Scale | 0.63 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 Scale | 7.42 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 Participants | 10 Participants | 26 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 17 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 62 Participants | 46 Participants | 108 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 20 Participants | 40 Participants |
| Race (NIH/OMB) White | 347 Participants | 326 Participants | 673 Participants |
| Region of Enrollment United States | 478 participants | 428 participants | 906 participants |
| Sex/Gender, Customized Men | 269 Participants | 271 Participants | 540 Participants |
| Sex/Gender, Customized Transexual or Non-Conforming Transgender or nonconforming | 2 Participants | 2 Participants | 4 Participants |
| Sex/Gender, Customized Unknown | 6 Participants | 6 Participants | 12 Participants |
| Sex/Gender, Customized Women | 201 Participants | 149 Participants | 350 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 478 | 1 / 428 |
| other Total, other adverse events | 0 / 478 | 0 / 428 |
| serious Total, serious adverse events | 4 / 478 | 1 / 428 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment As Usual | PARS Attitude Scale | 12.29 units on a scale | Standard Deviation 3.6 |
| Experimental | PARS Attitude Scale | 11.14 units on a scale | Standard Deviation 3.88 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment As Usual | PARS Help-Seeking Scale | 0.57 units on a scale | Standard Deviation 1.54 |
| Experimental | PARS Help-Seeking Scale | 0.53 units on a scale | Standard Deviation 1.66 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment As Usual | PARS Suicide Knowledge Scale | 7.47 units on a scale | Standard Deviation 1.89 |
| Experimental | PARS Suicide Knowledge Scale | 8.24 units on a scale | Standard Deviation 1.83 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment As Usual | Suicidal Behavior Questionnaire - Revised | 4.54 units on a scale | Standard Deviation 2.19 |
| Experimental | Suicidal Behavior Questionnaire - Revised | 4.82 units on a scale | Standard Deviation 2.41 |