Clinical High Risk for Psychosis (CHR)NCT07756567
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
A study testing Suicide Prevention Intervention in people with Clinical High Risk for Psychosis (CHR) and Suicidal Ideation, run by University of California, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR), Suicidal Ideation, Psychosis
- What is being tested?
- Suicide Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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
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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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Carrie Bearden, PhD, 310-206-2983, cbearden@mednet.ucla.edu
- Recruiting
University of California, San Diego
San Diego, California, 92161
Heline Mirzakhanian, PhD, 619-543-3199, carelab@health.ucsd.edu
About this study
Official title: Development of a Recovery-Oriented Suicide Prevention Intervention With Peers for Clinical High Risk for Psychosis
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.
- Being tested
- Suicide Prevention Intervention, Standard Care (in control arm)
- 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
- Medical subject headings
- Suicidal Ideation, Psychotic Disorders, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Prevention InterventionBehavioural
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.
Standard Care (in control arm)Behavioural
Coordinated speciality care for early psychosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Suicide Prevention Intervention |
| Standard care | Other | Standard care Receives: Behavioral: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Measured: From enrollment to the 3-month follow-up assessment
Retention Rate
Measured: From enrollment to the 3-month follow-up assessment
Intervention Attendance
Measured: 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.
Measured: The 3 month follow-up assessment
Secondary outcomes (7)
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.
Measured: From baseline to the 3-month follow-up assessment
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.
Measured: From baseline to the 3-month follow-up assessment
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.
Measured: From baseline to the 3-month follow-up assessment
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.
Measured: From baseline to the 3-month follow-up assessment
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.
Measured: From baseline to the 3-month follow-up assessment
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.
Measured: From baseline to the 3-month follow-up assessment
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.
Measured: From baseline to the 3-month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for Psychosis (CHR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Samantha A. Chalker, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756567
- Sponsor's protocol ID
- R01MH144654
- Other IDs
- R01MH144654
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes