- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558332
Youth Nominated Support Team (YST)
April 9, 2026 updated by: Jason Eric Schiffman, University of California, Irvine
Youth Nominated Support Team for Suicidal Adolescents at Clinical High Risk for Psychosis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92617
- The PREVENT Lab, University of California, Irvine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 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.
|
|
No Intervention: Treatment as usual
This group will receive their usual therapy/treatment as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3-months after intervention
|
|
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.
|
3-months after intervention
|
|
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.
|
3-months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 weeks after intervention, and 3 months after intervention
|
|
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.
|
baseline, 6 weeks after intervention, and 3 months after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Bertolote JM, Fleischmann A. Suicide and psychiatric diagnosis: a worldwide perspective. World Psychiatry. 2002 Oct;1(3):181-5. No abstract available.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
September 16, 2022
First Submitted That Met QC Criteria
September 23, 2022
First Posted (Actual)
September 28, 2022
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 9, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Behavioral Symptoms
- Self-Injurious Behavior
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Psychotic Disorders
- Suicide
- Patient Acceptance of Health Care
- Amino Acids, Peptides, and Proteins
- Proteins
- Membrane Proteins
- Carrier Proteins
- Peroxins
- Peroxisomal Biogenesis Factor 2
Other Study ID Numbers
- 2136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
VA Office of Research and DevelopmentRecruitingSuicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation | Suicide | Suicide AttemptUnited States
Clinical Trials on Youth-Nominated Support Teams for CHR
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation and BehaviorUnited States
-
Elizabeth ArnoldPatient-Centered Outcomes Research InstituteRecruitingSuicidal Ideation | SuicideUnited States
-
University of MichiganNational Institute of Mental Health (NIMH)Completed
-
University of MichiganNational Institute of Mental Health (NIMH); Children's Hospital of Michigan; ...CompletedSuicide PreventionUnited States
-
University of MichiganNational Institute of Mental Health (NIMH); Children's Hospital of Michigan; ...RecruitingBehavioral Symptoms | Suicide | Self-Injurious Behavior | Behavior | Suicide PreventionUnited States
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RecruitingClinical High Risk for Psychosis (CHR)United States
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Active, not recruitingPsychotic Disorders | Psychosis | Prodromal Schizophrenia | Prodromal Symptoms | FamilyUnited States, Canada
-
University of LuebeckMartin-Luther-Universität Halle-WittenbergCompleted
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Karolinska InstitutetRegion StockholmRecruitingAnger | Aggression | Child Behavior Problem | Oppositional Defiant Disorder | Disruptive Behavior | Conduct ProblemsSweden