Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis

NCT07756567 | Not Yet Recruiting DMC

• 1 other identifier: R01MH144654
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them. This study will develop and evaluate a recovery-oriented suicide prevention group program for young people at clinical high risk for psychosis. The program will be led by a clinician and a peer with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use the suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person. The study will first gather feedback from participants, caregivers, clinicians, and community advisors to refine the program. Researchers will then compare the program plus standard care with standard care alone to determine whether it improves personal recovery and increases participants' ability to remember and use suicide prevention strategies. Researchers will also collect feedback from participants and programm staff to better understand how the program can be integrated into early psychosis services.

Conditions

Clinical High Risk for Psychosis (CHR); Suicidal Ideation; Psychosis; Suicidal Behavior

Keywords

clinical high risk for psychosis; psychosis; early intervention; peer support; suicidal ideation; suicide; suicidal behavior; recovery; group intervention; implementation science; Hybrid Effectiveness-Implementation Trial

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  From enrollment to the 3-month follow-up assessment

• Retention Rate

  From enrollment to the 3-month follow-up assessment

• Intervention Attendance

  From enrollment to the end of the intervention at 9 weeks

• Acceptability

  Intervention acceptability will be assessed using the Acceptability of Intervention Measure (AIM). Total scores range from 4 to 20, with higher scores indicating greater perceived acceptability of the intervention.

  The 3 month follow-up assessment

Secondary Outcomes (7)

• Change from Baseline to 3-Month Follow-Up in Personal Recovery

  From baseline to the 3-month follow-up assessment

• Change from Baseline to 3-Month Follow-Up in Suicide Prevention Strategy Recall

  From baseline to the 3-month follow-up assessment

• Outpatient Mental Health Treatment Service Utilization

  From baseline to the 3-month follow-up assessment

• Suicide-Related Crisis Service Utilization

  From baseline to the 3-month follow-up assessment

• Change from Baseline to 3-Month Follow-Up in Social Functioning

  From baseline to the 3-month follow-up assessment

Study Arms (2)

Suicide Prevention Intervention

EXPERIMENTAL

The program will be led by a clinician and a peer with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use the suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person and promote recovery and stability. This program will be in addition to standard coordinated speciality care for early psychosis.

Behavioral: Suicide Prevention Intervention

Standard care

OTHER

Standard care

Behavioral: Standard Care (in control arm)

Interventions

Suicide Prevention Intervention BEHAVIORAL

The program will be led by a clinician and a peer specialist with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use the suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person and promote recovery and stability. This program will be in addition to coordinated speciality care for early psychosis.

Suicide Prevention Intervention

Standard Care (in control arm) BEHAVIORAL

Coordinated speciality care for early psychosis

Standard care

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• symptoms of clinical high risk for psychosis in the last two years
• lifetime active suicide ideation and/or lifetime suicide behavior
• has a caregiver willing to participate
• not able to read and write in English
• has a familial relationship with the young person participant
• has at least 4 hours of face-to-face contact with the patient participant every week, even if they do not live together

You may not qualify if:

• \*\*\*
• employed at the University of California, San Diego or University of California, Los Angeles early psychosis program

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, Los Angeles: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Psychotic Disorders; Suicide

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Samantha Chalker, PhD

CONTACT

619-821-9415; schalker@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)