Suicidal IdeationJaspr-PartBNCT06311591
Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B
A study testing Jaspr App in people with Suicidal Ideation and Suicide Attempt, run by University of Massachusetts, Worcester at 4 sites in United States.
Trial summary
This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide Attempt, Self Harm
- What is being tested?
- Jaspr App
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,908 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Nov 2024to 1 Jun 2027
- Phase
- Interventional
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
- >= 18 years old
- Positive for suicide risk on screener
- Reads English, or has proxy available to read and enter questions
Who cannot join
- Cognitively or emotionally incapable of engaging with Jaspr
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Ohio State East Hospital
Columbus, Ohio, 43210
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk - Part B: Real-World Study (RWS)
This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.
A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used
Read the detailed description
This study will evaluate Jaspr's patient-facing tablet-based application (app) during suicide-related ED visits. The app guides patients in completing the Suicide Status Interview, which comprises of evidence-based CAMS certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety plan, and lethal means safety counseling. It also offers access to a menu of "Comfort and Skills" modules that teaches patients behavioral skills to effectively manage imminent distress, while shared stories offer a library of professionally produced, racially and culturally diverse, inspirational videos of people with suicide-centered lived experience.
Subjects who engage with Jaspr can continue to access their safety plan, comfort and coping skills exercises, and the video library via Jaspr at Home (JAH) mobile application; a summary of the self-administered risk assessment is shared with the clinical team directly through the patient electronic health record to help guide the treatment plan.
Part A of the study will be a Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. It is reported in a separate CTG protocol (Unique Protocol ID: STUDY00000716 Part A)
This CTG protocol describes Part B of the study, which will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes. Two health systems affiliated with Ohio State University and the University of Colorado will implement Jaspr as part of routine clinical care. Each health system will implement Jaspr in two diverse EDs: one major academic site, and one community site. Each system will collect data on eligible patients across two Phases: (1) a retrospective enhanced treatment as usual (ETAU) phase comprising 12 months of index ED visits with a 12 month follow-up window, and (2) an Implementation/Intervention phase comprising 18 months of index ED visits with a 12 month follow-up window. Eligible patients will be defined as individuals 18 years or older who present to the ED in the designated date ranges and who screen positive for suicide risk on an evidence based screener administered clinically.
Data for all eligible patients across both phases will be collected. Data sources will be electronic health records (EHR) and state death registries. Data related to the index ED visit and all acute care visits within a 12 month follow-up window of the index visit will be collected. A limited dataset with personal identifiers removed will be shared with UMass Chan Medical School for harmonization and analyses.
- Conditions
- Suicidal Ideation, Suicide Attempt, Self Harm
- Being tested
- Jaspr App
- Keywords
- Suicide, Self-Harm, Attempt, Ideation, Suicidal thought, Suicidal plan, Crisis intervention, Suicide prevention, Emotional support, Mental Health, Behavioral Health, Psychiatry, Emergency Department, Technology, Mobile Application, Implementation, Safety Plan, Lethal Means
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Self-Injurious Behavior, Suicide, Suicide Prevention, Psychological Well-Being, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaspr AppDevice
Jaspr was designed to improve delivery of evidence-based, personalized suicide care in the ED. Jaspr (Dimeff, R44MH108222) is rooted in EBPs, including Collaborative Assessment and Management of Suicide (CAMS) and Dialectical Behavior Therapy (DBT). Briefly, Jaspr provides a patient interface, optimized for a tablet computer provided to the patient, which uses an avatar to administer: (1) the CAMS Suicide Status Form (SSF), an evidence-based suicide risk assessment; (2) crisis stabilization planning (CAMS' version of safety planning) or Stanley-Brown Safety Planning Intervention, depending on site choice; (3) lethal means safety counseling. Further, Jaspr teaches behavioral skills from DBT to manage imminent distress and has a library of over 40 racially and culturally diverse, inspirational videos of people with lived experience. Finally, Jaspr@home provides access to these resources after the visit during the high-risk transition to outpatient care.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Treatment as Usual (ETAU) Historical Control Group | No intervention | Enhanced Treatment As Usual (ETAU) Historical Control is defined as the treatment provided as part of routine clinical care in the participating EDs during a period of time when Jaspr was not being implemented. |
| Jaspr Implementation Group | Experimental | This group will receive the enhanced treatment as usual (ETAU) provided as part of routine clinical care at the participating EDs. They will also be considered by their treating team for administration of Jaspr. Jaspr administers a Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling, and allows open access to the Jaspr resource library. They can sign up to receive Jaspr at Home mobile app.
Electronic Health Records (EHR) will be used to assess the outcomes in the 12 months following the index visit. Receives: Device: Jaspr App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide composite, binary
Death by suicide OR suicide-related acute care utilization within 12 months after enrollment
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start7 Nov 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27,908 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Evidence-Based Practice Institute, Seattle, WA, National Institute of Mental Health (NIMH), Worcester Polytechnic Institute, University of Colorado, Denver
- Responsible party
- Principal investigator, Edwin Boudreaux, University of Massachusetts, Worcester
- Investigators
- Edwin D Boudreaux, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311591
- Sponsor's protocol ID
- STUDY00000716 Part B
- Other IDs
- 1P50MH129701
- Acronym
- Jaspr-PartB
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Investigators will comply with the expectations of the NIMH Data Archive (NDA) regarding data components and support documents, including the recommended timeline