Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Suicidal Ideation Clinical Trial

— ASSIST  

Official title:

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078970
• Other study ID #: 1R01MH123442
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2023
• Source: Seattle Children's Hospital
• Contact: Molly Adrian
• Phone: 206-987-7183
• Email: molly.adrian[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicidal Ideation
• Suicide
• Suicide and Self-harm
• Suicide Attempts
• Suicide Threat
• Suicide, Attempted

Intervention

Behavioral:
• Safety Planning Intervention+ (SPI+)
SPI is focused on how the risk of suicidal crisis waxes and wanes over time. At times of heightened risk, a pre-specified and individualized plan targets the internal warning signs that become the cue to use the safety plan. SPI+ strategies focus on patient's narrative of the suicidal crisis and identifying solutions that are antithetical to progressing in a suicidal crisis. The brief structured intervention is conducted in six key steps. Youth in this condition will be offered weekly follow-up, with a minimum of 4 sessions and a maximum of 8 sessions. The goal is to create a crisis response plan to reduce risk when suicidal crises emerge. With adolescents, SPI+ consists of an individual session to elicit crisis narrative and motivation to utilize the safety plan through psychoeducation and follows six steps to achieve the adolescent's goals and return to safety when suicidal urges are high.
• Collaborative Assessment and Management of Suicidality (CAMS)
CAMS strategies focus on collaborative deconstruction and treatment of the patient-defined drivers- the problems that make suicide compelling to the patient- and utilizes these problem-focused treatment sessions to treat the drivers as directly related to wish to die. Participants will be assigned to CAMS for a minimum of 4 sessions and maximum of eight sessions. This time frame, based on initial data from our pilot work with adolescents and emerging adults (18-25), suggests that a subset of participants resolve their STB in six to eight sessions. CAMS is a clinical intervention designed to modify how clinicians engage, assess and plan treatment with suicidal patients.
• Treatment As Usual
This assigned condition tracks the care received in typical circumstances.

Locations

Country	Name	City	State
United States	Nationwide Children's	Columbus	Ohio
United States	Seattle Children's	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal events	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.	Suicidal events at 12 months
Secondary	Suicide attempts	Self injurious behavior with intent to die as measured by the C-SSRS	Suicide attempts at 12 months
Secondary	Suicidal Ideation	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.	Change in score from baseline to 12 months