Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Suicide Attempts; Suicide and Self-harm; Suicide Threat

• Registration Number: NCT05078970
• Lead Sponsor: Seattle Children's Hospital

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.

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-15
• Study Start: 2022-08-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Suicidal events	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 Outcome Measures

Name	Time	Method
Suicide attempts	Suicide attempts at 12 months	Self injurious behavior with intent to die as measured by the C-SSRS
Suicidal Ideation	Change in score from baseline to 12 months	Severity of suicidal ideation as measured by the total score on the Suicidal Ideation Questionnaire Junior (SIQ-Jr. This 15 item measure is rated on a Likert scale, with scores ranging from 0 to 90, with higher scores reflecting worse outcomes and more severe ideation.

Trial Locations

Locations (2)

Nationwide Children's; 🇺🇸 Columbus, Ohio, United States

Seattle Children's; 🇺🇸 Seattle, Washington, United States