Trial Outcomes & Findings for Technology-Assisted Systems Change for Suicide Prevention (NCT NCT04720911)
NCT ID: NCT04720911
Last Updated: 2024-10-31
Results Overview
Suicide Attempt is based upon participant response to "Actual Suicide Attempt" question within the "Suicidal and Self-Injury Behavior" subsection of the Columbia Suicide Severity Rating Scale (C-SSRS). The question is a yes/no with a "checking of the box" selection meaning yes, Actual Suicide Attempt and blank/unchecked means no, no Actual Suicide Attempt". We also reviewed the medical chart for ED presentations to ascertain whether the participant presented to the ED for a suicide attempt. The timeframe applied was past three months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
3 months
Results posted on
2024-10-31
Participant Flow
The study was conducted at a large teaching hospital in the northeast United States, whose emergency department includes a dedicated psychiatric area. Recruitment took place at one emergency department at an academic medical center in the northeast U.S. between February 1 and September 15 2022.
Participant milestones
| Measure |
In-person TASCS
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
In-person TASCS: In-person clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.
Follow-up care: Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
|
Telehealth TASCS
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
Telehealth TASCS: Telehealth clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.
Follow-up care: Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
|
Self-administered TASCS
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
Self-administered TASCS: Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.
Follow-up care: Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
In-person TASCS
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
In-person TASCS: In-person clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.
Follow-up care: Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
|
Telehealth TASCS
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
Telehealth TASCS: Telehealth clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.
Follow-up care: Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
|
Self-administered TASCS
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
Self-administered TASCS: Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.
Follow-up care: Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Technology-Assisted Systems Change for Suicide Prevention
Baseline characteristics by cohort
| Measure |
Experimental: In-person TASCS
n=15 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=15 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=16 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
24 years
n=7 Participants
|
27 years
n=5 Participants
|
26.5 years
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Interpersonal Needs Questionnaire perceived burdensomeness subscale
|
18.27 units on a scale
STANDARD_DEVIATION 10.47 • n=5 Participants
|
20.67 units on a scale
STANDARD_DEVIATION 9.11 • n=7 Participants
|
19.31 units on a scale
STANDARD_DEVIATION 11.06 • n=5 Participants
|
19.41 units on a scale
STANDARD_DEVIATION 10.09 • n=4 Participants
|
|
Interpersonal Needs Questionnaire thwarted belongingness subscale
|
30.93 units on a scale
STANDARD_DEVIATION 15.43 • n=5 Participants
|
38.60 units on a scale
STANDARD_DEVIATION 9.08 • n=7 Participants
|
31.38 units on a scale
STANDARD_DEVIATION 13.88 • n=5 Participants
|
33.59 units on a scale
STANDARD_DEVIATION 13.28 • n=4 Participants
|
|
Behavioral Inhibition & Activation Scales (BIS/BAS) Drive subscale
|
10.33 units on a scale
STANDARD_DEVIATION 3.37 • n=5 Participants
|
10.73 units on a scale
STANDARD_DEVIATION 3.01 • n=7 Participants
|
12.38 units on a scale
STANDARD_DEVIATION 2.50 • n=5 Participants
|
11.17 units on a scale
STANDARD_DEVIATION 3.04 • n=4 Participants
|
|
Suicide-related impulsivity
|
2.63 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
3.10 units on a scale
STANDARD_DEVIATION 1.37 • n=7 Participants
|
3.25 units on a scale
STANDARD_DEVIATION 1.44 • n=5 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 1.36 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSuicide Attempt is based upon participant response to "Actual Suicide Attempt" question within the "Suicidal and Self-Injury Behavior" subsection of the Columbia Suicide Severity Rating Scale (C-SSRS). The question is a yes/no with a "checking of the box" selection meaning yes, Actual Suicide Attempt and blank/unchecked means no, no Actual Suicide Attempt". We also reviewed the medical chart for ED presentations to ascertain whether the participant presented to the ED for a suicide attempt. The timeframe applied was past three months.
Outcome measures
| Measure |
Experimental: In-person TASCS
n=15 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=15 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=16 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
|---|---|---|---|
|
Number of Participants With a Suicide Attempt in the Past Three Months
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Patients reachable by telephone at three months for follow-up
Presence (yes/no) of active suicidal ideation within the past week as measured by the 'Suicidal Ideation (Most Severe)' subsection of the Columbia Suicide Severity Rating Scale.
Outcome measures
| Measure |
Experimental: In-person TASCS
n=7 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=10 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=10 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
|---|---|---|---|
|
Number of Patients With Active Ideation in Past Week at 3-month Follow-up
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThwarted belongingness as a subscale of the Interpersonal Needs Questionnaire (INQ-15). This subscale has a minimum score of 9 and maximum of 63, with a higher score representing higher thwarted belongingness.
Outcome measures
| Measure |
Experimental: In-person TASCS
n=7 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=10 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=10 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
|---|---|---|---|
|
Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)
|
23.57 units on a scale
Standard Deviation 4.08
|
26.70 units on a scale
Standard Deviation 9.50
|
25.70 units on a scale
Standard Deviation 12.39
|
SECONDARY outcome
Timeframe: 3 monthsPerceived burdensomeness as a subscale of the Interpersonal Needs Questionnaire (INQ-15). This subscale has a minimum score of 6 and maximum of 42, with a higher score representing higher perceived burdensomeness .
Outcome measures
| Measure |
Experimental: In-person TASCS
n=7 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=10 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=10 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
|---|---|---|---|
|
Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)
|
10.86 units on a scale
Standard Deviation 4.91
|
11.30 units on a scale
Standard Deviation 5.87
|
14.40 units on a scale
Standard Deviation 11.05
|
SECONDARY outcome
Timeframe: 3 monthsBehavioral activation as measured by the Drive subscale of the Behavioral Activation Scale, part of the BIS/BAS Scale. This Drive subscale has a minimum score of 4 and maximum of 16, with a higher score representing a better outcome.
Outcome measures
| Measure |
Experimental: In-person TASCS
n=7 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=10 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=10 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
|---|---|---|---|
|
Drive Subscale of the Behavioral Activation Scale (Continuous)
|
11.43 units on a scale
Standard Deviation 1.72
|
11.90 units on a scale
Standard Deviation 1.85
|
12.20 units on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: 3 monthsSuicide-related impulse control will be assessed the Recent Impulsivity Scale, a two-item scale ("How strong was the impulse (urgent need) to plan or to act in any suicidal way?"; "How difficult was it for you to suppress or to restrain the impulse to plan or to act in any suicidal way?") on a five-point scale from "Not at all" to "Extremely". The instrument has a minimum score of 1 and a maximum score of 5, with a higher score representing a worse outcome.
Outcome measures
| Measure |
Experimental: In-person TASCS
n=7 Participants
This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician
|
Active Comparator: Telehealth TASCS
n=10 Participants
This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician
|
Active Comparator: Self-administered TASCS
n=10 Participants
This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician
|
|---|---|---|---|
|
Suicide-related Impulse Control (Continuous)
|
1.29 units on a scale
Standard Deviation .39
|
1.40 units on a scale
Standard Deviation 0.94
|
1.60 units on a scale
Standard Deviation 0.99
|
Adverse Events
Experimental: In-person TASCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Telehealth TASCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Self-administered TASCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place