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Clinical Trials/NCT05078970
NCT05078970RecruitingNot Applicable

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Seattle Children's Hospital2 sites in 1 country306 target enrollmentStarted: August 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
306
Locations
2
Primary Endpoint
Suicidal events

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Assessors will be blind to treatment assignment. It is not possible for clinicians or families to be blind to treatment procedures in psychotherapy since orientation to the model of care is part of psychotherapy.

Eligibility Criteria

Ages
11 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Safety Planning Intervention+ (SPI+)

Active Comparator

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.

Intervention: Safety Planning Intervention+ (SPI+) (Behavioral)

Collaborative Assessment and Management of Suicidality (CAMS)

Active Comparator

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 a 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.

Intervention: Collaborative Assessment and Management of Suicidality (CAMS) (Behavioral)

Treatment As Usual (TAU)

Active Comparator

Participants in this group will be studied as they proceed through treatment in the acute care setting and follow the intervention plan laid out in the discharge summary, per usual protocols at each facility. In both settings, the elements of typical care include crisis prevention planning, which outlines potential triggers, skills to use, and people and places to call in crisis, as well as referral to ongoing behavioral health treatment. We will not alter usual care but track recommendations, contacts and care through questionnaires the family completes as well as medical record review in order to understand the impact of the experimental conditions in relation to typical services.

Intervention: Treatment As Usual (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Molly Adrian

Associate Professor

Seattle Children's Hospital

Study Sites (2)

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