Clinical trial NCT05078970: Advancing Suicide Intervention Strategies for Teens During High Risk Periods
Official title: Advancing Suicide Intervention Strategies for Teens During High Risk Periods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Attempts
Suicidal Ideation
Suicide and Self-harm
Suicide Threat
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2021-10-15
Enrollment: 306
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1:1 ratio to

1. Safety Planning Intervention plus follow up,
2. Collaborative Assessment and Management of Suicidality, or
3. usual care
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Suicidal events
timeFrame: Suicidal events at 12 months
Secondary outcomes:
measure: Suicide attempts
timeFrame: Suicide attempts at 12 months
measure: Suicidal Ideation
timeFrame: Change in score from baseline to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Seattle Childrens
name: Molly Adrian
role: PRINCIPAL_INVESTIGATOR
References: