Advancing Suicide Intervention Strategies for Teens During High Risk Periods (ASSIST)

Seattle Children's Healthcare System

Status: Enrolling

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

Treatments: Behavioral: Treatment As Usual; Behavioral: Collaborative Assessment and Management of Suicidality (CAMS); Behavioral: Safety Planning Intervention+ (SPI+)

Study type: Interventional

Funder types: Other

Identifiers

NCT05078970

1R01MH123442

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 3 patient groups

Treatment As Usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment As Usual

Safety Planning Intervention+ (SPI+)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Safety Planning Intervention+ (SPI+)

Collaborative Assessment and Management of Suicidality (CAMS)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Collaborative Assessment and Management of Suicidality (CAMS)