- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07756567
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha Chalker, PhD
- Phone Number: 619-821-9415
- Email: schalker@health.ucsd.edu
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
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Contact:
- Carrie Bearden, PhD
- Phone Number: 310-206-2983
- Email: cbearden@mednet.ucla.edu
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San Diego, California, United States, 92161
- University of California, San Diego
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Contact:
- Heline Mirzakhanian, PhD
- Phone Number: 619-543-3199
- Email: carelab@health.ucsd.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Standard care
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Coordinated speciality care for early psychosis
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: From enrollment to the 3-month follow-up assessment
|
From enrollment to the 3-month follow-up assessment
|
|
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Retention Rate
Time Frame: From enrollment to the 3-month follow-up assessment
|
From enrollment to the 3-month follow-up assessment
|
|
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Intervention Attendance
Time Frame: From enrollment to the end of the intervention at 9 weeks
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From enrollment to the end of the intervention at 9 weeks
|
|
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Acceptability
Time Frame: The 3 month follow-up assessment
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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.
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The 3 month follow-up assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From baseline to the 3-month follow-up assessment
|
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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.
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From baseline to the 3-month follow-up assessment
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Outpatient Mental Health Treatment Service Utilization
Time Frame: From baseline to the 3-month follow-up assessment
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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.
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From baseline to the 3-month follow-up assessment
|
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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.
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From baseline to the 3-month follow-up assessment
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Change from Baseline to 3-Month Follow-Up in Social Functioning
Time Frame: From baseline to the 3-month follow-up assessment
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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.
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From baseline to the 3-month follow-up assessment
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Change from Baseline to 3-Month Follow-Up of Suicide Ideation Severity
Time Frame: From baseline to the 3-month follow-up assessment
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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.
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From baseline to the 3-month follow-up assessment
|
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Change from Baseline to 3-Month Follow-Up in Role Functioning
Time Frame: From baseline to the 3-month follow-up assessment
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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.
|
From baseline to the 3-month follow-up assessment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Behavioral Symptoms
- Self-Injurious Behavior
- Behavior
- Psychotic Disorders
- Suicide
- Suicidal Ideation
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- R01MH144654 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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