- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06701006
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
60
Phase
- 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
- Name: Laura Richardson, MD, MPH
- Phone Number: 206-987-2028
- Email: lpr@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98115
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Adia Abler, BA
- Phone Number: 206-884-1895
- Email: Adia.Abler@seattlechildrens.org
-
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
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 |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
|
|
|
Experimental: Integrated skills and safety planning app
Use of Jaspr app for clinical care + at home
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- 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)
August 19, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
November 20, 2024
First Submitted That Met QC Criteria
November 20, 2024
First Posted (Actual)
November 22, 2024
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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