Trial Outcomes & Findings for Preventing Addiction Related Suicide (PARS) (NCT NCT03166709)
NCT ID: NCT03166709
Last Updated: 2025-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
906 participants
Primary outcome timeframe
Six months
Results posted on
2025-08-14
Participant Flow
Recruitment completed between October 2017 and September 2019
Unit of analysis: Site
Participant milestones
| Measure |
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).
|
Group 2: 8 Months TAU, Then 16 Months PARS
Group 2: 90 day Intensive Outpatient Program - 8 months Treatment as Usual (Control Condition), 16 months PARS (Experimental Condition)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|---|
|
Step 1 (Months 1-4)
STARTED
|
29 3
|
38 3
|
39 3
|
42 3
|
38 3
|
|
Step 1 (Months 1-4)
COMPLETED
|
23 3
|
24 3
|
23 3
|
25 3
|
27 3
|
|
Step 1 (Months 1-4)
NOT COMPLETED
|
6 0
|
14 0
|
16 0
|
17 0
|
11 0
|
|
Step 2 (Months 5-8)
STARTED
|
23 3
|
34 3
|
21 3
|
37 3
|
34 3
|
|
Step 2 (Months 5-8)
COMPLETED
|
19 3
|
28 3
|
16 3
|
23 3
|
25 3
|
|
Step 2 (Months 5-8)
NOT COMPLETED
|
4 0
|
6 0
|
5 0
|
14 0
|
9 0
|
|
Step 3 (Months 9-12)
STARTED
|
23 3
|
28 3
|
26 3
|
27 3
|
24 3
|
|
Step 3 (Months 9-12)
COMPLETED
|
19 3
|
17 3
|
19 3
|
12 3
|
18 3
|
|
Step 3 (Months 9-12)
NOT COMPLETED
|
4 0
|
11 0
|
7 0
|
15 0
|
6 0
|
|
Step 4 (Months 13-16)
STARTED
|
27 3
|
29 3
|
26 3
|
26 3
|
34 3
|
|
Step 4 (Months 13-16)
COMPLETED
|
22 3
|
23 3
|
17 3
|
13 3
|
26 3
|
|
Step 4 (Months 13-16)
NOT COMPLETED
|
5 0
|
6 0
|
9 0
|
13 0
|
8 0
|
|
Step 5 (Months 17-20)
STARTED
|
34 3
|
32 3
|
31 3
|
29 3
|
29 3
|
|
Step 5 (Months 17-20)
COMPLETED
|
25 3
|
21 3
|
24 3
|
17 3
|
21 3
|
|
Step 5 (Months 17-20)
NOT COMPLETED
|
9 0
|
11 0
|
7 0
|
12 0
|
8 0
|
|
Step 6 (Months 21-24)
STARTED
|
41 3
|
27 3
|
25 3
|
22 3
|
31 3
|
|
Step 6 (Months 21-24)
COMPLETED
|
27 3
|
13 3
|
18 3
|
11 3
|
20 3
|
|
Step 6 (Months 21-24)
NOT COMPLETED
|
14 0
|
14 0
|
7 0
|
11 0
|
11 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
40 participants did not provide their age
Baseline characteristics by cohort
| Measure |
Treatment As Usual
n=478 Participants
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.
|
Experimental
n=428 Participants
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
|
Total
n=906 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=450 Participants • 40 participants did not provide their age
|
0 Participants
n=416 Participants • 40 participants did not provide their age
|
0 Participants
n=866 Participants • 40 participants did not provide their age
|
|
Age, Categorical
Between 18 and 65 years
|
445 Participants
n=450 Participants • 40 participants did not provide their age
|
411 Participants
n=416 Participants • 40 participants did not provide their age
|
856 Participants
n=866 Participants • 40 participants did not provide their age
|
|
Age, Categorical
>=65 years
|
5 Participants
n=450 Participants • 40 participants did not provide their age
|
5 Participants
n=416 Participants • 40 participants did not provide their age
|
10 Participants
n=866 Participants • 40 participants did not provide their age
|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 12.4 • n=450 Participants • 40 participants did not provide their age
|
37.7 years
STANDARD_DEVIATION 11.7 • n=416 Participants • 40 participants did not provide their age
|
37.5 years
STANDARD_DEVIATION 12.0 • n=866 Participants • 40 participants did not provide their age
|
|
Sex/Gender, Customized
Women
|
201 Participants
n=478 Participants
|
149 Participants
n=428 Participants
|
350 Participants
n=906 Participants
|
|
Sex/Gender, Customized
Men
|
269 Participants
n=478 Participants
|
271 Participants
n=428 Participants
|
540 Participants
n=906 Participants
|
|
Sex/Gender, Customized
Transexual or Non-Conforming Transgender or nonconforming
|
2 Participants
n=478 Participants
|
2 Participants
n=428 Participants
|
4 Participants
n=906 Participants
|
|
Sex/Gender, Customized
Unknown
|
6 Participants
n=478 Participants
|
6 Participants
n=428 Participants
|
12 Participants
n=906 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=478 Participants
|
42 Participants
n=428 Participants
|
73 Participants
n=906 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
439 Participants
n=478 Participants
|
378 Participants
n=428 Participants
|
817 Participants
n=906 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=478 Participants
|
8 Participants
n=428 Participants
|
16 Participants
n=906 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
16 Participants
n=478 Participants
|
10 Participants
n=428 Participants
|
26 Participants
n=906 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=478 Participants
|
7 Participants
n=428 Participants
|
18 Participants
n=906 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=478 Participants
|
2 Participants
n=428 Participants
|
8 Participants
n=906 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=478 Participants
|
17 Participants
n=428 Participants
|
33 Participants
n=906 Participants
|
|
Race (NIH/OMB)
White
|
347 Participants
n=478 Participants
|
326 Participants
n=428 Participants
|
673 Participants
n=906 Participants
|
|
Race (NIH/OMB)
More than one race
|
62 Participants
n=478 Participants
|
46 Participants
n=428 Participants
|
108 Participants
n=906 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=478 Participants
|
20 Participants
n=428 Participants
|
40 Participants
n=906 Participants
|
|
Region of Enrollment
United States
|
478 participants
n=478 Participants
|
428 participants
n=428 Participants
|
906 participants
n=906 Participants
|
|
PARS Suicide Knowledge Scale
|
7.42 units on a scale
STANDARD_DEVIATION 1.68 • n=478 Participants
|
7.76 units on a scale
STANDARD_DEVIATION 1.70 • n=428 Participants
|
7.58 units on a scale
STANDARD_DEVIATION 1.69 • n=906 Participants
|
|
PARS Attitude Scale
|
12.81 units on a scale
STANDARD_DEVIATION 3.25 • n=478 Participants
|
12.58 units on a scale
STANDARD_DEVIATION 3.38 • n=428 Participants
|
12.70 units on a scale
STANDARD_DEVIATION 3.32 • n=906 Participants
|
|
PARS Help-Seeking Scale
|
0.63 units on a scale
STANDARD_DEVIATION 1.45 • n=478 Participants
|
0.48 units on a scale
STANDARD_DEVIATION 1.14 • n=428 Participants
|
0.56 units on a scale
STANDARD_DEVIATION 1.32 • n=906 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: Missing data for 107 participants.
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.
Outcome measures
| Measure |
Experimental
n=388 Participants
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
|
Treatment As Usual
n=411 Participants
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.
|
|---|---|---|
|
PARS Help-Seeking Scale
|
0.53 units on a scale
Standard Deviation 1.66
|
0.57 units on a scale
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Six monthsPopulation: Missing data from 95 participants
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.
Outcome measures
| Measure |
Experimental
n=391 Participants
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
|
Treatment As Usual
n=420 Participants
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.
|
|---|---|---|
|
PARS Suicide Knowledge Scale
|
8.24 units on a scale
Standard Deviation 1.83
|
7.47 units on a scale
Standard Deviation 1.89
|
PRIMARY outcome
Timeframe: Six monthsPopulation: Missing data for 121 participants.
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.
Outcome measures
| Measure |
Experimental
n=382 Participants
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
|
Treatment As Usual
n=403 Participants
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.
|
|---|---|---|
|
PARS Attitude Scale
|
11.14 units on a scale
Standard Deviation 3.88
|
12.29 units on a scale
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Intent-to-treat
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
Outcome measures
| Measure |
Experimental
n=428 Participants
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
|
Treatment As Usual
n=478 Participants
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.
|
|---|---|---|
|
Suicidal Behavior Questionnaire - Revised
|
4.82 units on a scale
Standard Deviation 2.41
|
4.54 units on a scale
Standard Deviation 2.19
|
Adverse Events
Treatment As Usual
Serious events: 4 serious events
Other events: 0 other events
Deaths: 4 deaths
Experimental
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment As Usual
n=478 participants at risk
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.
|
Experimental
n=428 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Suicide Attempt, Psychiatric Hospitalization or Any Death
|
0.84%
4/478 • Number of events 4 • 6 months
|
0.23%
1/428 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Katherine Anne Comtois
Center for Suicide Prevention and Recovery, University of Washington
Phone: 206-744-1752
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place