Integrated Suicide Supports and Safety Planning for Youth (ISSP)

May 14, 2026 updated by: Laura Richardson, University of Washington

Integrated Screening and Safety Planning (ISSP) for Adolescents With Suicidal Thoughts

The goal of this clinical trial is to evaluate an app to help keep teens and young adults with suicidal thoughts safe. The app includes a safety plan created by adolescents and healthcare providers, and videos to encourage supportive communication and skills for teens and young adults to stay safe. The main question it aims to answer is whether the use of an app can increase youth suicide-related coping for youth with suicidal ideation, parent/caregiver suicide prevention self-efficacy, and healthcare provider self-efficacy in suicide management. Researchers will compare usual care to usual care with the app. Participants, including adolescents, caregivers, and healthcare providers, will use the ISSP app (if assigned to that group) and view video content and complete three online surveys.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current study aims to evaluate the Jaspr app relative to usual care among youth (ages 13-21 years) who indicate suicidal ideation in pediatric medical settings. The Jaspr app includes supported safety planning between the young person and the healthcare provider, as well as skills and support videos for youth and caregivers intended to increase coping and decrease distress with an opportunity to access these resources through an at home app. Adolescents, parents, and clinicians will participate in the project to assess the effectiveness of Jaspr augmenting usual care, compared to usual care alone. The study will use a pre-post design in which each setting begins with a control period and then transitions to the addition of Jaspr following healthcare provider training on use of the app. Participants and their parents/caregivers will receive study assessments at baseline, 1-month, and 2-month follow up timepoints, and healthcare providers complete a survey at baseline, and the end of each period (control and intervention). Study assessments with youth will ask about coping, suicidal ideation and severity, anxiety and depression, service utilization, functional impairment, access to lethal means, and acceptability of the app. Study assessments for parents/caregivers will ask about their self-efficacy in managing their youth's suicidality, acceptability of the videos/app, and service utilization for the youth. Healthcare providers will complete surveys assessing their self-efficacy in managing youth suicidality and feasibility of use of the app. Youth, their legal guardian, and healthcare providers each assent/consent to participate in the research procedures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Laura Richardson, MD, MPH
  • Phone Number: 206-987-2028
  • Email: lpr@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98115
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
        • Principal Investigator:
          • Laura Richardson, MD MPH
        • Principal Investigator:
          • Cari McCarty, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Youth Inclusion Criteria:

  • Age 13 -21 years, an Ask Suicide Questions (ASQ) screen score of 1-5 with active ideation (not solely a history of a prior attempt) but no current plan or intent, or patient-reported suicidal thoughts and behaviors during a clinical assessment in a medical setting who are judged by a clinician to be appropriate for conducting higher level assessment in that setting (including a BSSA and/or safety planning) in order to support care at home.
  • Parents/guardians: One "parent" per AYA will also be invited to participate.
  • HCPs: All HCPs in participating settings who may conduct assessments of SI and safety planning (physicians, nurse practitioners/physician's assistants, social workers, mental health counselors, psychologists) will be invited to participate.
  • All subjects must have access to the internet and a computer or tablet device.

Youth Exclusion Criteria:

  • Concurrently enrolled in an affiliated Suicide Care Research Center study, no phone access, or non-English speaking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Experimental: Integrated skills and safety planning app
Use of Jaspr app for clinical care + at home
Other: Integrated skills and safety planning app
This is a digital app that includes supported safety planning resources in medical settings as well as coping skills and lived experience videos for adolescents, young adults and parents/caregivers that can be accessed while in the medical setting or at home.
Other Names:
  • Jaspr

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Youth Suicide-Related Coping
Time Frame: Baseline, 1 month, 2 month
Total Score on the 17-item Youth Suicide-Related Coping Scale
Baseline, 1 month, 2 month
Parent suicide prevention self-efficacy
Time Frame: Baseline, 1 month, 2 month
Total score on the Parent suicide prevention self-efficacy scale
Baseline, 1 month, 2 month
Healthcare provider self-efficacy in suicide management
Time Frame: Baseline, end of control period, and end of intervention period
Total score on the Provider suicide Intervention Questionnaire
Baseline, end of control period, and end of intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Youth Suicide Severity
Time Frame: Baseline, 1 month, 2 month
Total score on the online self-report version of the Columbia Suicide Severity Rating Scale (C-SSRS)
Baseline, 1 month, 2 month
Youth Anxiety Symptoms
Time Frame: Baseline, 1 month, 2 month
Total Score on Youth Self-Reported Generalized Anxiety Disorder -7 item scale
Baseline, 1 month, 2 month
Intervention Acceptability
Time Frame: Baseline, 1 month, 2 month
Youth and Parent Report on the Acceptability of Intervention Measure (AIM)
Baseline, 1 month, 2 month
Functional Impairment
Time Frame: Baseline, 1 month, 2 month
Total score on the youth reported EQ-5D-Y quality of life measure
Baseline, 1 month, 2 month
Youth Suicidal ideation
Time Frame: Baseline, 1 month, 2 month
Total Score on the Harkavy Asnis Suicide Scale ideation subscale (HASS-I),
Baseline, 1 month, 2 month
Youth Depressive Symptoms
Time Frame: Baseline, 1 month, 2 month
Total score on the Patient Health Questionnaire 9
Baseline, 1 month, 2 month
Safety Plan Quality
Time Frame: Up to 1 month
Safety Planning Scoring Algorithm (SPISA) based on youth medical chart review
Up to 1 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intervention Feasibility
Time Frame: Baseline, 1 month, 2 month
Healthcare Provider Report on the Feasibility of Intervention Measure (FIM)
Baseline, 1 month, 2 month
Mental Health Services Use
Time Frame: Baseline, 2 months
Dichotomous rating of any mental health service use following baseline using chart review or indication based on parent or youth report on the Services Assessment for Children and Adolescents (SACA)
Baseline, 2 months
Access to Lethal Means
Time Frame: 1 month
BRFSS Module 17 - Youth report of access to a firearm
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Seattle Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Richardson, MD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00020199
  • P50MH129708 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share required elements with the NIMH NDA.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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