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
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Sponsor:
University of California, Irvine
Collaborator:
University of Maryland, Baltimore County
Information provided by (Responsible Party):
Jason Eric Schiffman, University of California, Irvine
Tracking Information | |||||||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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.
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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 |
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Condition ICMJE |
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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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 25 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |