NCT04720911: TASCS

Technology-Assisted Systems Change for Suicide Prevention

Completed NA Results posted Last updated 31 October 2024

What this trial tests

NA trial testing In-person TASCS in Suicide in 47 participants. Completed in 31 December 2022.

Timeline

1 February 2022

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	47
Start date	1 February 2022
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• In-person TASCS
• Telehealth TASCS
• Self-administered TASCS
• Follow-up care

Conditions studied

• Suicide — all drugs for Suicide →
• Suicide, Attempted — all drugs for Suicide, Attempted →

Sponsor

University of Massachusetts, Worcester

Who can join

18 and older, any sex, with Suicide or Suicide, Attempted. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Suicide Attempt in the Past Three Months Primary · 3 months

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.

Group	Value	95% CI
Experimental: In-person TASCS	0
Active Comparator: Telehealth TASCS	1
Active Comparator: Self-administered TASCS	1

Number of Patients With Active Ideation in Past Week at 3-month Follow-up Primary · 3 months

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.

Group	Value	95% CI
Experimental: In-person TASCS	0
Active Comparator: Telehealth TASCS	3
Active Comparator: Self-administered TASCS	2

Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15) Secondary · 3 months

Thwarted 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.

Group	Value	95% CI
Experimental: In-person TASCS	23.57	± 4.08
Active Comparator: Telehealth TASCS	26.70	± 9.50
Active Comparator: Self-administered TASCS	25.70	± 12.39

Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15) Secondary · 3 months

Perceived 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 .

Group	Value	95% CI
Experimental: In-person TASCS	10.86	± 4.91
Active Comparator: Telehealth TASCS	11.30	± 5.87
Active Comparator: Self-administered TASCS	14.40	± 11.05

Drive Subscale of the Behavioral Activation Scale (Continuous) Secondary · 3 months

Behavioral 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.

Group	Value	95% CI
Experimental: In-person TASCS	11.43	± 1.72
Active Comparator: Telehealth TASCS	11.90	± 1.85
Active Comparator: Self-administered TASCS	12.20	± 3.01

Suicide-related Impulse Control (Continuous) Secondary · 3 months

Suicide-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.

Group	Value	95% CI
Experimental: In-person TASCS	1.29	± .39
Active Comparator: Telehealth TASCS	1.40	± 0.94
Active Comparator: Self-administered TASCS	1.60	± 0.99

Sponsor's own description

Effective prevention of suicide among adult emergency department (ED) patients hinges on an indispensable component: the ability to translate evidence-based interventions into routine clinical practice on a broad scale and with fidelity to the intervention components so they can have a maximum public health effect. However, there are critical barriers that prevent such translation, including a lack of trained clinicians, competing priorities in busy EDs, and incompatibility between requirements of evidence-based interventions (such as completing telephone coaching with patients after the ED visit) and the workflow and infrastructure typically present in most EDs. The proposed new intervention will address these barriers by building a suite of technologies that will make it easier to implement the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE), an evidence-based suicide intervention targeting perceived social support, behavioral activation and impulse control, revolutionizing the field's ability to scale and implement this intervention and acting as a model for efforts to implement other existing and emerging suicide interventions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing the Acceptability and Quality of Intervention Modalities for Suicidality in the Emergency Department: Randomized Feasibility Trial.
   Larkin C, Tulu B, Djamasbi S, Garner R, et al · · 2023 · cited 3× · PMID 37874619 · DOI 10.2196/49783