SuicideTASCSNCT04720911
Technology-Assisted Systems Change for Suicide Prevention
A study testing In-person TASCS, Telehealth TASCS and Self-administered TASCS in people with Suicide and Suicide, Attempted, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicide, Attempted
- What is being tested?
- In-person TASCS, Telehealth TASCS and Self-administered TASCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Presenting to selected emergency departments during the study period
- Screened positive for active suicidal ideation in the past 2 weeks or attempt in the past 6 months
- Has a smartphone and access to the internet
Who cannot join
- Cognitively impaired (as assessed by study staff)
- <18 years of age
- Prisoner.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the detailed description
The TASCS will be the first health information technology designed to enable flexible delivery of the ED-SAFE intervention components with strong fidelity and with responsiveness to the conditions and barriers present in most EDs. This will include an integrated approach to delivering components usually completed during the ED visit, such as personalized safety planning, as well as those completed after the visit, such as coaching to foster mental health treatment engagement. This R34 addresses both patient and implementation outcomes.
Aim 1 will use persona development, an innovative human computer interaction approach, to ensure the TASCS is intimately informed by end users.
Aim 2 will optimize the TASCS in a small field test in the ED.
Aim 3, modeled after a Hybrid Type 2 effectiveness-implementation design, will gather data on usability, acceptability, and implementation of the TASCS ED App using a randomized experiment (n=45) of three modalities: (1) On site (n=15), (2) Telehealth (n=15), and (3) Self-administered (n=15). For 3 months post-discharge, all participants will receive coaching calls, facilitated by the Post-ED Clinician App, and will have access to the Post-ED Patient and Family App. The intervention is intended to decrease suicidal ideation and behavior by improving perceived social support, increasing behavioral activation, and improving suicide-related impulse control.
Building a comprehensive suite of integrated enabling technologies to address ED-SAFE translation barriers will not only improve ED-SAFE intervention adoption, it will provide a road map for how to do the same for other suicide interventions, both existing and those yet to be developed, maximizing impact on the field.
- Conditions
- Suicide, Suicide, Attempted
- Being tested
- In-person TASCS, Telehealth TASCS, Self-administered TASCS, Follow-up care
- Medical subject headings
- Suicide, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person TASCSBehavioural
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.
Telehealth TASCSBehavioural
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.
Self-administered TASCSBehavioural
Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.
Follow-up careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| In-person TASCS | Experimental | 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 Receives: Behavioral: In-person TASCS; Behavioral: Follow-up care |
| Telehealth TASCS | Active comparator | 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 Receives: Behavioral: Telehealth TASCS; Behavioral: Follow-up care |
| Self-administered TASCS | Active comparator | 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 Receives: Behavioral: Self-administered TASCS; Behavioral: Follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Suicide Attempt in the Past Three 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.
Measured: 3 months
Number of Patients With Active Ideation in Past Week at 3-month 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.
Measured: 3 months
Secondary outcomes (4)
Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)
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.
Measured: 3 months
Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)
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 .
Measured: 3 months
Drive Subscale of the Behavioral Activation Scale (Continuous)
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.
Measured: 3 months
Suicide-related Impulse Control (Continuous)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Worcester Polytechnic Institute
- Responsible party
- Principal investigator, Celine Larkin, University of Massachusetts, Worcester
- Investigators
- Celine Larkin, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720911
- Sponsor's protocol ID
- H00020238
- Other IDs
- R34MH123578
- Acronym
- TASCS
- Status last verified
- Oct 2024
- First submitted
- 18 Jan 2021
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIMH will host the trial dataset on the National Database for Clinical Trials related to Mental Illness.
Publications
Larkin C, Tulu B, Djamasbi S, Garner R, Varzgani F, Siddique M, Pietro J, Boudreaux ED. Comparing the Acceptability and Quality of Intervention Modalities for Suicidality in the Emergency Department: Randomized Feasibility Trial. JMIR Ment Health. 2023 Oct 24;10:e49783. doi: 10.2196/49783.
PubMed 37874619
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Assisted Systems Change for Suicide Prevention
- ClinicalTrials.gov ID
- NCT04720911
- Acronym / sponsor ID
- TASCS / H00020238
- Conditions
- Suicide, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Worcester Polytechnic Institute
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The TASCS will be the first health information technology designed to enable flexible delivery of the ED-SAFE intervention components with strong fidelity and with responsiveness to the conditions and barriers present in most EDs. This will include an integrated approach to delivering components usually completed during the ED visit, such as personalized safety planning, as well as those completed after the visit, such as coaching to foster mental health treatment engagement. This R34 addresses both patient and implementation outcomes.
Aim 1 will use persona development, an innovative human computer interaction approach, to ensure the TASCS is intimately informed by end users.
Aim 2 will optimize the TASCS in a small field test in the ED.
Aim 3, modeled after a Hybrid Type 2 effectiveness-implementation design, will gather data on usability, acceptability, and implementation of the TASCS ED App using a randomized experiment (n=45) of three modalities: (1) On site (n=15), (2) Telehealth (n=15), and (3) Self-administered (n=15). For 3 months post-discharge, all participants will receive coaching calls, facilitated by the Post-ED Clinician App, and will have access to the Post-ED Patient and Family App. The intervention is intended to decrease suicidal ideation and behavior by improving perceived social support, increasing behavioral activation, and improving suicide-related impulse control.
Building a comprehensive suite of integrated enabling technologies to address ED-SAFE translation barriers will not only improve ED-SAFE intervention adoption, it will provide a road map for how to do the same for other suicide interventions, both existing and those yet to be developed, maximizing impact on the field.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person TASCS | Experimental | Behavioral: In-person TASCS, Behavioral: Follow-up careThis 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 |
| Telehealth TASCS | Active comparator | Behavioral: Telehealth TASCS, Behavioral: Follow-up careThis 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 |
| Self-administered TASCS | Active comparator | Behavioral: Self-administered TASCS, Behavioral: Follow-up careThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Presenting to selected emergency departments during the study period
- Screened positive for active suicidal ideation in the past 2 weeks or attempt in the past 6 months
- Has a smartphone and access to the internet
Key exclusion criteria (3 listed)
- Cognitively impaired (as assessed by study staff)
- <18 years of age
- Prisoner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person TASCSIn-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. | Behavioural | In-person TASCS |
| Telehealth TASCSTelehealth 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. | Behavioural | Telehealth TASCS |
| Self-administered TASCSSelf-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App. | Behavioural | Self-administered TASCS |
| Follow-up careCounseling 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 | Behavioural | In-person TASCS, Self-administered TASCS, Telehealth TASCS |
Primary outcome
Number of Participants With a Suicide Attempt in the Past Three Months
Time frame: 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.
Number of Patients With Active Ideation in Past Week at 3-month Follow-up
Time frame: 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.
4 secondary outcomes
Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)
Time frame: 3 months
Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)
Time frame: 3 months
Drive Subscale of the Behavioral Activation Scale (Continuous)
Time frame: 3 months
Suicide-related Impulse Control (Continuous)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37874619Larkin C, Tulu B, Djamasbi S, Garner R, Varzgani F, Siddique M, Pietro J, Boudreaux ED. Comparing the Acceptability and Quality of Intervention Modalities for Suicidality in the Emergency Department: Randomized Feasibility Trial. JMIR Ment Health. 2023 Oct 24;10:e49783. doi: 10.2196/49783.
- Individual participant dataSharing planned: Yes. NIMH will host the trial dataset on the National Database for Clinical Trials related to Mental Illness.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celine Larkin, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person TASCS, Telehealth TASCS and Self-administered TASCS in people with Suicide and Suicide, Attempted, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Suicide Attempt in the Past Three Months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.