NCT05558332

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Mar 2025Nov 2026

First Submitted

Initial submission to the registry

September 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

September 16, 2022

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    3-months after intervention

  • 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.

    3-months after intervention

  • Treatment Engagement

    This will be measured using clinic records of appointment attendance to determine number of therapy sessions attended.

    3-months after intervention

Secondary Outcomes (2)

  • Severity and Intensity of Suicidal Ideation

    Baseline, 6 weeks after intervention, and 3 months after intervention

  • Severity and Intensity of Suicidal Ideation

    baseline, 6 weeks after intervention, and 3 months after intervention

Other Outcomes (1)

  • Interpersonal Conflict

    3 months after intervention

Study Arms (2)

YST-CHR Group

EXPERIMENTAL

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

Behavioral: Youth-Nominated Support Teams for CHR

Treatment as usual

NO INTERVENTION

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

Interventions

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.

YST-CHR Group

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The PREVENT Lab, University of California, Irvine

Irvine, California, 92617, United States

Location

Related Publications (5)

  • 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.

    PMID: 15753237BACKGROUND
  • 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.

    PMID: 29986446BACKGROUND
  • Bertolote JM, Fleischmann A. Suicide and psychiatric diagnosis: a worldwide perspective. World Psychiatry. 2002 Oct;1(3):181-5. No abstract available.

    PMID: 16946849BACKGROUND
  • 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.

    PMID: 19319456BACKGROUND
  • 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.

    PMID: 25230813BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersSuicidePatient Acceptance of Health Care

Interventions

Peroxisomal Biogenesis Factor 2

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

PeroxinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Training

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 28, 2022

Study Start

March 12, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations