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
About this trial
This is an interventional treatment trial for Psychosis
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)
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
NCT ID
NCT05558332
First Posted
September 16, 2022
Last Updated
September 23, 2022
Sponsor
University of California, Irvine
Collaborators
University of Maryland, Baltimore County
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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Youth Nominated Support Team
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