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NCT Number: NCT07756567

Developing a Recovery-Oriented Suicide Prevention Program for Young People at 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 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.

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Key information

Conditions

Clinical High Risk for Psychosis (CHR) Behavior Behavioral Symptoms Mental Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Self-Injurious Behavior Suicidal Behavior Suicidal Ideation Suicide

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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, participants' ability to remember and use suicide prevention strategies, suicide thoughts, and engagement in mental health care.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Care (in control arm)

Behavioral

Coordinated speciality care for early psychosis

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

    Time frame: The 3 month follow-up assessment

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Outpatient Mental Health Treatment Service Utilization

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

    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.

  4. Suicide-Related Crisis Service Utilization

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Chalker, PhD

CONTACT

[email protected]

619-821-9415

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of California, Los Angeles

Registry information

Official study title

Development of a Recovery-Oriented Suicide Prevention Intervention With Peers for Clinical High Risk for Psychosis

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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