Back to resultsAdvancing Suicide Intervention Strategies for Teens During High Risk Periods (ASSIST)
Primary Purpose
Suicide Attempts, Suicidal Ideation, Suicide and Self-harm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning Intervention+ (SPI+)
Collaborative Assessment and Management of Suicidality (CAMS)
Treatment As Usual
Sponsored by
About this trial
This is an interventional treatment trial for Suicide Attempts
Eligibility Criteria
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
Sites / Locations
- Nationwide Children'sRecruiting
- Seattle Children'sRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Treatment As Usual (TAU)
Safety Planning Intervention+ (SPI+)
Collaborative Assessment and Management of Suicidality (CAMS)
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Suicide attempts
Self injurious behavior with intent to die as measured by the C-SSRS
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.
Full Information
NCT ID
NCT05078970
First Posted
September 22, 2021
Last Updated
May 17, 2023
Sponsor
Seattle Children's Hospital
Collaborators
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05078970
Brief Title
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
Acronym
ASSIST
Official Title
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Nationwide Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempts, Suicidal Ideation, Suicide and Self-harm, Suicide Threat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 1:1:1 ratio to
Safety Planning Intervention plus follow up,
Collaborative Assessment and Management of Suicidality, or
usual care
Masking
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.
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm 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.
Arm Title
Safety Planning Intervention+ (SPI+)
Arm Type
Active Comparator
Arm 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.
Arm Title
Collaborative Assessment and Management of Suicidality (CAMS)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning Intervention+ (SPI+)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Assessment and Management of Suicidality (CAMS)
Intervention 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 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 Type
Behavioral
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
Usual Care
Intervention Description
This assigned condition tracks the care received in typical circumstances.
Primary Outcome Measure Information:
Title
Suicidal events
Description
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.
Time Frame
Suicidal events at 12 months
Secondary Outcome Measure Information:
Title
Suicide attempts
Description
Self injurious behavior with intent to die as measured by the C-SSRS
Time Frame
Suicide attempts at 12 months
Title
Suicidal Ideation
Description
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.
Time Frame
Change in score from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Adrian
Phone
206-987-7183
Email
molly.adrian@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly Adrian
Organizational Affiliation
Seattle Childrens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Hart
Email
emily.hart@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Jeff Bridge
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Adrian
Email
molly.adrian@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Assist Study
Email
assist@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Molly Adrian
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
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