Clinical trial NCT06701006: Integrated Suicide Supports for Youth
Official title: Integrated Screening and Safety Planning (ISSP) for Adolescents with Suicidal Thoughts
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicidal Behavior
Keywords: adolescents
young adults
suicide prevention
health services research
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This trial will use a pre- post- sequential design in which each clinic has a control period (usual care), followed by provider training, and then an intervention period (usual care plus Jaspr app).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 in the clinic, 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 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, their caregivers and healthcare providers, will use the ISSP app (if assigned to that group) 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 outpatient 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 clinic 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 will receive study assessments at baseline, 1-month, and 2-month follow up timepoints, and healthcare providers complete a survey at baseline, the end of the control period, and the end of the intervention period. Study assessments with youth will ask about coping, suicidal ideation and severity, anxiety and depression, service utilization, functional impairment, access to lethal means, therapeutic alliance, and satisfaction with care and the app. Study assessments for parents will ask about their self-efficacy in managing their youth's suicidality, service utilization for the youth, and satisfaction with care. Healthcare providers will complete surveys assessing their self-efficacy in managing youth suicidality. Youth, their legal guardian, and healthcare providers each assent/consent to participate in the research procedures.

Eligibility criteria: Youth Inclusion Criteria:

* Age 13-21 years, Ask Suicide Questions (ASQ) screen score of 1-4 with no current plan or intent (Item 5 negative and as assessed by their clinical providers).

Youth Exclusion Criteria:

* Previously recruited to other affiliated Suicide Care Research Center study, no phone access, non-English speaking, or already has a suicide safety plan that is being overseen by a mental health specialist.

Note: One parent/caregiver per teen/young adult and health care providers in participating clinics will also be invited to be study participants

Primary outcomes:
measure: Youth Suicide-Related Coping
timeFrame: Baseline, 1 month, 2 month
measure: Parent suicide prevention self-efficacy
timeFrame: Baseline, 1 month, 2 month
measure: Heathcare provider self-efficacy in suicide management
timeFrame: Baseline, end of control period, and end of intervention period
Secondary outcomes:
measure: Safety Plan Quality
timeFrame: Up to 1 week
measure: Youth Suicide Severity
timeFrame: Baseline, 1 month, 2 month
measure: Youth Anxiety Symptoms
timeFrame: Baseline, 1 month, 2 month
measure: Intervention Acceptability
timeFrame: Baseline, 1 month, 2 month
measure: Functional Impairment
timeFrame: Baseline, 1 month, 2 month
measure: Youth Suicidal ideation
timeFrame: Baseline, 1 month, 2 month
measure: Youth Depressive Symptoms
timeFrame: Baseline, 1 month, 2 month
Other outcomes:
measure: Therapeutic Alliance
timeFrame: 1 month
measure: Access to Lethal Means
timeFrame: 1 month
measure: Satisfaction with Care
timeFrame: 2 months
measure: Intervention Feasibility
timeFrame: Baseline, 1 month, 2 month
measure: Mental Health Services Use
timeFrame: 2 months
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Washington
name: Laura Richardson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: