ClinicalTrials.gg
RecruitingNCT07756567Updated Oct 22, 2026

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

An interventional study of Suicide Prevention Intervention and Standard Care (in control arm) in Clinical High Risk for Psychosis (CHR), Suicidal Ideation and Psychosis, sponsored by University of California, San Diego. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Updated Oct 22, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
12 Years to 30 Years
Sex
All
01

Study 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 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 program staff to better understand how the program can be integrated into early psychosis services.

Read the detailed description

Young people at clinical high risk for psychosis experience elevated rates of suicide thoughts and behaviors, yet there are few suicide prevention interventions designed specifically for this population. This study will develop and evaluate a recovery-oriented suicide prevention group intervention that integrates peer support with clinician-led care and is designed for implementation within early psychosis services.

This hybrid type 1 effectiveness-implementation study will be conducted over approximately three years at two early psychosis programs. During the first phase, the intervention will be refined through input from young people with lived experience, caregivers, clinicians, and community advisors, followed by an open trial to evaluate feasibility, acceptability, fidelity, and any additional adaptations needed before broader evaluation.

The second phase will consist of a pilot randomized controlled trial comparing the intervention plus standard care with standard care alone. The study will examine preliminary effects on personal recovery and participants' ability to remember and use suicide prevention strategies.

The final phase will evaluate factors that may influence future implementation of the intervention in routine early psychosis services. Interviews with participants and program staff will be used to identify barriers and facilitators to implementation and to inform resources that support future adoption and sustainability if the intervention proves promising.

02

Conditions studied

  • 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
03

In context

Suicidal Ideation

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 108 is above the median of 80 across 469 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Young Person Inclusion Criteria:

  • 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

Young Person Exclusion Criterion:

  • not able to read and write in English

Caregiver Inclusion Criteria:

  • 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

Caregiver Exclusion Criteria: None

***

Administrator/Clinician Inclusion Criteria:

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

Administrator/Clinician Exclusion Criteria: None

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Suicide Prevention Intervention

    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

  • Other
    Standard care

    Standard care

    Behavioral: Standard Care (in control arm)

Interventions

  • BehavioralSuicide Prevention Intervention

    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.

  • BehavioralStandard Care (in control arm)

    Coordinated speciality care for early psychosis

06

What researchers measure

Primary outcomes

  1. Recruitment Rate

    Time frame: From enrollment to the 3-month follow-up assessment

  2. Retention Rate

    Time frame: From enrollment to the 3-month follow-up assessment

  3. Intervention Attendance

    Time frame: From enrollment to the end of the intervention at 9 weeks

  4. 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.

    Time frame: The 3 month follow-up assessment

Secondary outcomes

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

    Personal recovery will be assessed using the Recovery Assessment Scale-41 (RAS-41). Total scores range from 41 to 205, with higher scores indicating greater personal recovery.

    Time frame: From baseline to the 3-month follow-up assessment

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

    Suicide prevention strategy recall will be assessed by the Suicide Prevention Strategy Recall Task, which collects a count of the number of strategies recalled with a higher number indicating more strategies recalled.

    Time frame: From baseline to the 3-month follow-up assessment

  3. Outpatient Mental Health Treatment Service Utilization

    Outpatient Treatment Service Utilization will be assessed as a composite count of outpatient mental health treatment appointments attended during the follow-up period. Data will be abstracted from the electronic medical record and supplemented with participant self-report to capture services received outside the health system. Services include individual therapy, group therapy, family therapy, medication management, and other outpatient mental health visits.

    Time frame: From baseline to the 3-month follow-up assessment

  4. Suicide-Related Crisis Service Utilization

    Crisis Service Utilization will be assessed using a composite measure of suicide-related crisis service encounters. Data will be abstracted from the electronic medical record and supplemented with participant self-report to capture services received outside the health system. Services include emergency department visits, emergency psychiatric services, and inpatient psychiatric hospitalizations.

    Time frame: From baseline to the 3-month follow-up assessment

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

    Social functioning will be assessed using the Global Functioning: Social Scale (GF: Social). The scale ranges from 1 to 10, with higher scores indicating better social functioning.

    Time frame: From baseline to the 3-month follow-up assessment

  6. Change from Baseline to 3-Month Follow-Up of Suicide Ideation Severity

    Suicide ideation severity will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) Severity of Ideation subscale. Scores range from 0 to 5, where 0 indicates no suicide ideation and higher scores indicate greater severity of suicide ideation.

    Time frame: From baseline to the 3-month follow-up assessment

  7. Change from Baseline to 3-Month Follow-Up in Role Functioning

    Role functioning will be assessed using the Global Functioning: Role Scale (GF: Role). The scale ranges from 1 to 10, with higher scores indicating better role functioning.

    Time frame: From baseline to the 3-month follow-up assessment

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 22, 2026
Sites
2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • University of California, Los Angeles · Los Angeles, United Statesno status→Recruiting
  • University of California, San Diego · San Diego, United Statesno status→Recruiting
Oct 22, 2026
Start date
Aug 2026→Oct 2026
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • University of California, Los Angeles · Los Angeles, United Statesno status→Recruiting
    • University of California, San Diego · San Diego, United Statesno status→Recruiting
    Start date Aug 2026→Oct 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07756567
Responsible party
Samantha A. Chalker (Assistant Professor, University of California, San Diego) — Principal investigator
First posted
Aug 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Samantha Chalker, PhD
Contact
schalker@health.ucsd.edu
619-821-9415

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion