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Youth Nominated Support Team (YST)

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ClinicalTrials.gov Identifier: NCT05558332
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : February 26, 2024
Sponsor:
Collaborator:
University of Maryland, Baltimore County
Information provided by (Responsible Party):
Jason Eric Schiffman, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE September 16, 2022
First Posted Date  ICMJE September 28, 2022
Last Update Posted Date February 26, 2024
Estimated Study Start Date  ICMJE September 2024
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2022)
  • Social Connectedness [ Time Frame: 3-months after intervention ]
    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 [ Time Frame: 3-months after intervention ]
    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 [ Time Frame: 3-months after intervention ]
    This will be measured using clinic records of appointment attendance to determine number of therapy sessions attended.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2022)
  • Severity and Intensity of Suicidal Ideation [ Time Frame: Baseline, 6 weeks after intervention, and 3 months after intervention ]
    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 [ Time Frame: baseline, 6 weeks after intervention, and 3 months after intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2022)
Interpersonal Conflict [ Time Frame: 3 months after intervention ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Youth Nominated Support Team
Official Title  ICMJE Youth Nominated Support Team for Suicidal Adolescents at Clinical High Risk for Psychosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Psychosis
  • Suicide
  • Health Care Utilization
  • Family Members
Intervention  ICMJE Behavioral: Youth-Nominated Support Teams for CHR
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.
Study Arms  ICMJE
  • Experimental: YST-CHR Group
    This group will recieve the new adapted YST treatment (YST-CHR). Clinicians will administer this treatment. Neither group will be blind.
    Intervention: Behavioral: Youth-Nominated Support Teams for CHR
  • No Intervention: Treatment as usual
    This group will receive their usual therapy/treatment as usual.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2022)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason E Schiffman, PhD 424-291-2159 jeschiff@uci.edu
Contact: Samantha Jay, MA 201-452-0343 sjay1@umbc.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05558332
Other Study ID Numbers  ICMJE 480
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jason Eric Schiffman, University of California, Irvine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Irvine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Maryland, Baltimore County
Investigators  ICMJE Not Provided
PRS Account University of California, Irvine
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP