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Youth Nominated Support Team (YST)

Primary Purpose

Psychosis, Suicide, Health Care Utilization

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Youth-Nominated Support Teams for CHR
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A person with suicidal ideation in the past 3 months or suicidal attempt in the past year
  • A person who is receiving or has received treatment for psychosis risk symptoms
  • Between the ages of 12-25

Exclusion Criteria:

  • Cannot have participated in the first 2 phases of the study (focus groups and adaption of the YST-CHR manual)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    YST-CHR Group

    Treatment as usual

    Arm Description

    This group will recieve the new adapted YST treatment (YST-CHR). Clinicians will administer this treatment. Neither group will be blind.

    This group will receive their usual therapy/treatment as usual.

    Outcomes

    Primary Outcome Measures

    Social Connectedness
    Connectedness will be measured with the 5-item Thwarted Belongingness subscale of the Interpersonal Needs Questionnaire. Scores range from 15-105 and a higher score indicates lower social connectedness.
    Increased Hope
    Hopelessness will be measured with the 4-item Beck Hopelessness Scale (BHS). Hopelessness may be a very sensitive indicator of subsequent suicide risk, particularly among youth with psychosis. The total BHS score is a sum of item responses from 0 to 20 such that higher scores reflect higher levels of hopelessness. Scores greater than 14 identify severe hopelessness.
    Treatment Engagement
    This will be measured using clinic records of appointment attendance to determine number of therapy sessions attended.

    Secondary Outcome Measures

    Severity and Intensity of Suicidal Ideation
    This will be drawn from the Columbia Suicide Severity Rating Scale (C-SSRS). The scores range from 0 to 25. Higher scores indicate higher suicide risk symptoms.
    Severity and Intensity of Suicidal Ideation
    This will also be drawn from the Suicide History of Assessment for People with Psychosis-Spectrum Experiences (SHAPE). This measure is used to query about suicidal thoughts and actions and history with these experiences. It is not scored but used to get a better understanding of the participant's thoughts and feelings related to suicide.

    Full Information

    First Posted
    September 16, 2022
    Last Updated
    September 23, 2022
    Sponsor
    University of California, Irvine
    Collaborators
    University of Maryland, Baltimore County
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05558332
    Brief Title
    Youth Nominated Support Team
    Acronym
    YST
    Official Title
    Youth Nominated Support Team for Suicidal Adolescents at Clinical High Risk for Psychosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Irvine
    Collaborators
    University of Maryland, Baltimore County

    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
    This study aims to adapt the current Youth-Nominated Support Team (YST) manual used to treat suicide risk for people at clinical high risk for psychosis.
    Detailed Description
    Psychotic disorders are characterized by high rates of suicidal ideation and behavior, and the risk for suicide appears to be greatest during the earliest stages of psychosis. A recent meta-analysis showed that the majority of youth at clinical high-risk (CHR) for psychosis experience suicidal ideation, and that approximately one in five make at least one suicide attempt. There are, however, no suicide prevention interventions specifically tailored to the needs of transition-aged youth at CHR, and no current best practice guidelines for how to respond to suicide risk in this population. The Youth-Nominated Support Team (YST) intervention has recently been shown to reduce mortality among adolescents and is potentially highly adaptable within the context of existing CHR services. YST is intended as an adjunctive treatment and is primarily delivered towards support persons rather than the youth themselves, and therefore would not interfere or overlap with the already extensive direct services provided in CHR treatment settings. The proposed project intends to adapt the YST intervention for CHR populations. Specifically, the investigators aim to: (1) adapt YST for CHR based on stakeholder input (i.e., clients, family/friends, clinicians) and to develop a new treatment manual and submit an additional IRB to cover the next two aims -- (2) to implement YST in a single CHR clinic and to revise the intervention based on input from clients, providers, and support person and (3) conduct a pilot randomized clinical trial at four SAMHSA funded CHR sites to test the efficacy of the adapted YST intervention and to identify underlying mechanisms of change. The investigators hypothesize that the revised intervention will be superior to existing practice for the reduction of suicidal ideation and behavior.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis, Suicide, Health Care Utilization, Family Members

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One group will recieve the adapted YST treatment (YST-CHR) and the other group will receive treatment as usual. Participants receiving the existing treatment will be offered YST-CHR after the study is over if appropriate
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    YST-CHR Group
    Arm Type
    Experimental
    Arm Description
    This group will recieve the new adapted YST treatment (YST-CHR). Clinicians will administer this treatment. Neither group will be blind.
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    This group will receive their usual therapy/treatment as usual.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Youth-Nominated Support Teams for CHR
    Intervention Description
    Intervention for adolescents aimed at preventing, reducing, and/or managing suicidal thoughts and behaviors. YST-CHR is an "add on" to the treatment and therapy they are already receiving. Study clinicians will administer the adapted YST treatment manual to participants, aimed at improving suicidal risk.
    Primary Outcome Measure Information:
    Title
    Social Connectedness
    Description
    Connectedness will be measured with the 5-item Thwarted Belongingness subscale of the Interpersonal Needs Questionnaire. Scores range from 15-105 and a higher score indicates lower social connectedness.
    Time Frame
    3-months after intervention
    Title
    Increased Hope
    Description
    Hopelessness will be measured with the 4-item Beck Hopelessness Scale (BHS). Hopelessness may be a very sensitive indicator of subsequent suicide risk, particularly among youth with psychosis. The total BHS score is a sum of item responses from 0 to 20 such that higher scores reflect higher levels of hopelessness. Scores greater than 14 identify severe hopelessness.
    Time Frame
    3-months after intervention
    Title
    Treatment Engagement
    Description
    This will be measured using clinic records of appointment attendance to determine number of therapy sessions attended.
    Time Frame
    3-months after intervention
    Secondary Outcome Measure Information:
    Title
    Severity and Intensity of Suicidal Ideation
    Description
    This will be drawn from the Columbia Suicide Severity Rating Scale (C-SSRS). The scores range from 0 to 25. Higher scores indicate higher suicide risk symptoms.
    Time Frame
    Baseline, 6 weeks after intervention, and 3 months after intervention
    Title
    Severity and Intensity of Suicidal Ideation
    Description
    This will also be drawn from the Suicide History of Assessment for People with Psychosis-Spectrum Experiences (SHAPE). This measure is used to query about suicidal thoughts and actions and history with these experiences. It is not scored but used to get a better understanding of the participant's thoughts and feelings related to suicide.
    Time Frame
    baseline, 6 weeks after intervention, and 3 months after intervention
    Other Pre-specified Outcome Measures:
    Title
    Interpersonal Conflict
    Description
    Test of Negative Social Exchange (TENSE). Participants score statements on a scale from 0 to 9. Items are summed together to create a composite score. Higher scores on the TENSE indicate higher frequency of negative social exchange.
    Time Frame
    3 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A person with suicidal ideation in the past 3 months or suicidal attempt in the past year A person who is receiving or has received treatment for psychosis risk symptoms Between the ages of 12-25 Exclusion Criteria: Cannot have participated in the first 2 phases of the study (focus groups and adaption of the YST-CHR manual)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jason E Schiffman, PhD
    Phone
    424-291-2159
    Email
    jeschiff@uci.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samantha Jay, MA
    Phone
    201-452-0343
    Email
    sjay1@umbc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15753237
    Citation
    Palmer BA, Pankratz VS, Bostwick JM. The lifetime risk of suicide in schizophrenia: a reexamination. Arch Gen Psychiatry. 2005 Mar;62(3):247-53. doi: 10.1001/archpsyc.62.3.247.
    Results Reference
    background
    PubMed Identifier
    29986446
    Citation
    Bachmann S. Epidemiology of Suicide and the Psychiatric Perspective. Int J Environ Res Public Health. 2018 Jul 6;15(7):1425. doi: 10.3390/ijerph15071425.
    Results Reference
    background
    PubMed Identifier
    16946849
    Citation
    Bertolote JM, Fleischmann A. Suicide and psychiatric diagnosis: a worldwide perspective. World Psychiatry. 2002 Oct;1(3):181-5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19319456
    Citation
    Alaraisanen A, Miettunen J, Rasanen P, Fenton W, Koivumaa-Honkanen HT, Isohanni M. Suicide rate in schizophrenia in the Northern Finland 1966 Birth Cohort. Soc Psychiatry Psychiatr Epidemiol. 2009 Dec;44(12):1107-10. doi: 10.1007/s00127-009-0033-5. Epub 2009 Mar 25.
    Results Reference
    background
    PubMed Identifier
    25230813
    Citation
    Popovic D, Benabarre A, Crespo JM, Goikolea JM, Gonzalez-Pinto A, Gutierrez-Rojas L, Montes JM, Vieta E. Risk factors for suicide in schizophrenia: systematic review and clinical recommendations. Acta Psychiatr Scand. 2014 Dec;130(6):418-26. doi: 10.1111/acps.12332. Epub 2014 Sep 18.
    Results Reference
    background

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