ASSIST: Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05078970
Collaborator
Nationwide Children's Hospital (Other)
306
2
3
46.7
153
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Safety Planning Intervention+ (SPI+)
  • Behavioral: Collaborative Assessment and Management of Suicidality (CAMS)
  • Behavioral: Treatment As Usual
N/A

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
Anticipated Enrollment :
306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 careParticipants 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:
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.
Primary Purpose:
Treatment
Official Title:
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
Actual Study Start Date :
Aug 11, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of two interventions SPI+ and CAMS compared to usual care in 11-17-year-olds [Suicidal events at 12 months]

      1.1: Both interventions will result in lower rates of suicidal events in 11-17-year-olds during the treatment and follow-up periods compared to usual care. Suicidal events is defined as 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. 1.2: SPI+ will demonstrate superiority to CAMS in decreasing suicide attempts over 1 year. Suicide attempts are defined as self-injurious behavior with intent to die as measured by the C-SSRS. 1.3: CAMS will demonstrate superiority to SPI+ in decreasing suicidal thoughts over 1 year. Suicidal thoughts are defined as thoughts of wanting to end one's life and measured by the Suicidal Ideation Questionnaire-Jr.

    Secondary Outcome Measures

    1. Analyze the mechanisms of change resulting in reduced suicide events for SPI+ and CAMS [Suicidal events at 12 months]

      2.1: Decreases in attentional biases will mediate reductions in suicide events for CAMS. 2.2: Increases in self-efficacy will mediate reductions in suicide events for SPI+

    2. Analyze moderators of treatment impact for SPI+ and CAMS in reducing suicidal events [Suicidal events at 12 months]

      3.1: Youth with higher levels of social problem solving will benefit more from SPI+ compared to CAMS. 3.2:Youth with lower levels of family cohesion may benefit more from CAMS compared to SPI+.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Columbus Ohio United States 43205
    2 Seattle Children's Seattle Washington United States 98115

    Sponsors and Collaborators

    • Seattle Children's Hospital
    • Nationwide Children's Hospital

    Investigators

    • Principal Investigator: Molly Adrian, Seattle Childrens

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Molly Adrian, Associate Professor, Seattle Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05078970
    Other Study ID Numbers:
    • 1R01MH123442
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022