Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part A

NCT06223867 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00000716 Part A1P50MH129701
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

This Study will comprehensively evaluate 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

Conditions

Suicidal Ideation; Suicide Attempt; Self Harm

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

Outcome Measures

Primary Outcomes (1)

• Suicide composite, binary

  Death by suicide OR suicide-related acute care utilization within 12 months after enrollment

  12 months after enrollment

Secondary Outcomes (3)

• Suicidal attempt

  12 months after enrollment

• Suicidal behavior

  12 months after enrollment

• Suicidal ideation severity

  12 months after enrollment

Other Outcomes (25)

• Evidence-Based Practice (EBP) delivery

  During index visit= Day 1

• Patient target engagement, perceived social support

  12 months after enrollment

• Patient target engagement, suicide-related coping

  12 months after enrollment

Study Arms (2)

Enhanced treatment as usual (ETAU) alone

ACTIVE COMPARATOR

Subjects in this arm will receive the usual care for patients with suicidal risk at UMass Memorial ED that may include a behavioral health evaluation by a trained clinician, and environmental safety precautions dictated by risk level (Mild, Moderate, High). Individuals deemed appropriate for discharge undergo discharge planning and offered a personalized safety plan using the Stanley-Brown Safety Planning Intervention, including lethal means safety counseling.

Behavioral: ETAU

Jaspr intervention with enhanced treatment as usual (ETAU)

EXPERIMENTAL

Subjects in this arm will receive ETAU in addition, they will complete a guided Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling on the Jaspr tablet-based app before open access to the Jaspr resource library. Subjects can sign up to receive JAH mobile app.

Device: Jaspr App + JAH; Behavioral: ETAU

Interventions

Jaspr App + JAH DEVICE

With assistance form a research coordinator, the subject will complete self-administered suicide risk assessment on the tablet via Jaspr app, then the subject will engage with suicide-related coping skills and resources that the app provides. Subject will continue to have access to the coping skills and videos via a mobile app after discharge.

Jaspr intervention with enhanced treatment as usual (ETAU)

ETAU BEHAVIORAL

Usual care for suicidal patients at UMass Memorial ED that may include Behavioral health evaluation by a trained clinician. Environmental safety precautions. Personalized safety upon discharge

Also known as: Enhanced Treatment As Usual

Enhanced treatment as usual (ETAU) alone; Jaspr intervention with enhanced treatment as usual (ETAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for suicide risk on the Patient Safety Screener in the ED (active suicidal ideation int the past 2 weeks, or suicidal attempt in the past 6 months)
• Cognitively and emotionally capable of consent and engaging in Jaspr app.
• Reads English at 6th grade level.
• Reliable telephone access.
• Owns a smart phone
• Lives in Massachusetts

You may not qualify if:

• Prisoners or in state custody
• Adults unable to consent
• Patient \<18 yeas
• Enrolled subjects during the 12 month follow-up period

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Ohio State University: collaborator
• Evidence-Based Practice Institute, Seattle, WA: collaborator
• Worcester Polytechnic Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

UMass Memorial Health

Worcester, Massachusetts, 01655, United States

RECRUITING

Related Links

• The Center for Accelerating Practices to End Suicide through Technology Translation (CAPES)- Signature Project

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior; Suicide; Suicide Prevention; Psychological Well-Being; Emergencies

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edwin D Boudreaux, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwin D Boudreaux, PhD

CONTACT

508-334-3817; Edwin.Boudreaux@umassmed.edu

Mhd B Rahmoun, MD

CONTACT

Mhd.Rahmoun@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome evaluators will be blinded to study condition. It is not possible to blind participants, the research staff enrolling the participant, or the treating clinicians.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 25, 2024
• Study Start: February 23, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Based on NIMH NDA expectations, investigators will begin sharing data and share data with as long as is expected by NIMH
• Access Criteria: See NDA application for details.

Locations

US (1)