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Clinical Trials/NCT05078970
NCT05078970
Recruiting
Not Applicable

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Seattle Children's Hospital2 sites in 1 country306 target enrollmentAugust 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide Attempts
Sponsor
Seattle Children's Hospital
Enrollment
306
Locations
2
Primary Endpoint
Suicidal events
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

To inform the effective management of adolescent suicide risk by evaluating promising treatments and developing the evidence-base for interventions that are well suited for widespread adoption, sustained quality, and impact.

Detailed Description

The current study aims to evaluate Safety Planning Intervention with follow-up (SPI+), Collaborative Assessment and Management of Suicidality (CAMS) and usual care. Adolescents, parents, and clinicians will participate in the project to advance to following Research Aims: 1) Assess the comparative effectiveness of CAMS and SPI+ compared to usual care, 2) Evaluate the mechanism of change accounting for the therapeutic effects of the interventions 3) Identify moderators of treatment effects. Participants and their parents will receive study assessments at baseline, 2-week, 1-month, 2-month, 6-month, and 12-month timepoints. Study assessments will ask about participant demographics (sample characterization), suicide attempts, suicidal ideation, non-suicidal self-injury, service utilization, self-assessed risk, treatment integrity, sleep, family cohesion, and social experiences. Youth participants and their legal guardian both consent to participate in the research procedures.

Registry
clinicaltrials.gov
Start Date
August 11, 2022
End Date
January 31, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Molly Adrian

Associate Professor

Seattle Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Provision of signed and dated informed consent form
  • Youth, aged 11-17
  • Endorse suicidal ideation and/or behavior
  • Admitted to acute care (emergency, inpatient medical or inpatient psychiatric) due to suicidality

Exclusion Criteria

  • Presence of psychosis, intellectual disability, autism spectrum disorder, eating disorder with unstable vitals
  • Limited English proficiency that would interfere with the ability to complete study assessments

Outcomes

Primary Outcomes

Suicidal events

Time Frame: Suicidal events at 12 months

Change the rate of suicidal events as measured by death by suicide, attempted suicide, preparatory acts toward imminent suicidal behavior, or suicidal ideation resulting in a change in treatment plan or emergency evaluation as measured by the C-SSRS.

Secondary Outcomes

  • Suicide attempts(Suicide attempts at 12 months)
  • Suicidal Ideation(Change in score from baseline to 12 months)

Study Sites (2)

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