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Recruiting NCT06701006

Integrated Suicide Supports and Safety Planning for Youth

No phase Interventional Suicidal Ideation Suicidal Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated skills and safety planning app.
Who it may be relevant to
Registry conditions: Suicidal Ideation, Suicidal Behavior. Basic parameters: 13 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Youth Suicide-Related Coping [Time frame: Baseline, 1 month, 2 month]
  • Parent suicide prevention self-efficacy [Time frame: Baseline, 1 month, 2 month]
  • Healthcare provider self-efficacy in suicide management [Time frame: Baseline, end of control period, and end of intervention period]
Secondary outcome measures (7)
  • Safety Plan Quality [Time frame: Up to 1 month]
  • Youth Suicide Severity [Time frame: Baseline, 1 month, 2 month]
  • Youth Anxiety Symptoms [Time frame: Baseline, 1 month, 2 month]
  • Intervention Acceptability [Time frame: Baseline, 1 month, 2 month]
  • Functional Impairment [Time frame: Baseline, 1 month, 2 month]
  • Youth Suicidal ideation [Time frame: Baseline, 1 month, 2 month]
  • Youth Depressive Symptoms [Time frame: Baseline, 1 month, 2 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT06701006 · STUDY00020199 · P50MH129708

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗