Advancing Suicide Intervention Strategies for Teens During High Risk Periods

NCT05078970 | Recruiting DMC

• 1 other identifier: 1R01MH123442
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Suicide attempts

  Suicide attempts at 12 months

• Suicidal Ideation

  Change in score from baseline to 12 months

Study Arms (3)

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.

Behavioral: Treatment As Usual

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.

Behavioral: Safety Planning Intervention+ (SPI+)

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.

Behavioral: Collaborative Assessment and Management of Suicidality (CAMS)

Interventions

Safety Planning Intervention+ (SPI+) BEHAVIORAL

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.

Safety Planning Intervention+ (SPI+)

Collaborative Assessment and Management of Suicidality (CAMS) BEHAVIORAL

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.

Collaborative Assessment and Management of Suicidality (CAMS)

Treatment As Usual BEHAVIORAL

This assigned condition tracks the care received in typical circumstances.

Also known as: Usual Care

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Nationwide Children's Hospital: collaborator

Study Sites (2)

Nationwide Children's

Columbus, Ohio, 43205, United States

RECRUITING

Seattle Children's

Seattle, Washington, 98115, United States

RECRUITING

Related Publications (1)

• Adrian M, McCauley E, Gallop R, Stevens J, Jobes DA, Crumlish J, Stanley B, Brown GK, Green KL, Hughes JL, Bridge JA. Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial. BMJ Open. 2023 Dec 12;13(12):e074116. doi: 10.1136/bmjopen-2023-074116.

  PMID: 38086585 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation; Suicide; Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Molly Adrian

  Seattle Childrens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Adrian

CONTACT

206-987-7183; molly.adrian@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 15, 2021
• Study Start: August 11, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available in the NIMH NDA 1 year from study completion.
• Access Criteria: NIMH NDA access criteria applies.

Locations

US (2)