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

May 17, 2023 updated by: Molly Adrian, Seattle Children's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment As Usual (TAU)
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
This assigned condition tracks the care received in typical circumstances.
Other Names:
  • Usual Care
Active Comparator: 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.
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.
Active Comparator: 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 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Suicidal events at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicide attempts
Time Frame: Suicide attempts at 12 months
Self injurious behavior with intent to die as measured by the C-SSRS
Suicide attempts at 12 months
Suicidal Ideation
Time Frame: Change in score from baseline to 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Molly Adrian, Seattle Childrens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Anticipated)

August 1, 2026

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH123442 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be submitted to the National Institute of Mental Health Data Repository

IPD Sharing Time Frame

Data will be available in the NIMH NDA 1 year from study completion.

IPD Sharing Access Criteria

NIMH NDA access criteria applies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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