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

10. august 2026 oppdatert av: Samantha A. Chalker, University of California, San Diego

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

108

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • University of California, Los Angeles
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92161
        • University of California, San Diego
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Standard omsorg
Atferdsmessig: Standard Care (in control arm)
Coordinated speciality care for early psychosis
Eksperimentell: 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.
Atferdsmessig: Suicide 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recruitment Rate
Tidsramme: From enrollment to the 3-month follow-up assessment
From enrollment to the 3-month follow-up assessment
Retention Rate
Tidsramme: From enrollment to the 3-month follow-up assessment
From enrollment to the 3-month follow-up assessment
Intervention Attendance
Tidsramme: From enrollment to the end of the intervention at 9 weeks
From enrollment to the end of the intervention at 9 weeks
Acceptability
Tidsramme: 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.
The 3 month follow-up assessment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline to 3-Month Follow-Up in Personal Recovery
Tidsramme: 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.
From baseline to the 3-month follow-up assessment
Change from Baseline to 3-Month Follow-Up in Suicide Prevention Strategy Recall
Tidsramme: 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.
From baseline to the 3-month follow-up assessment
Outpatient Mental Health Treatment Service Utilization
Tidsramme: 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.
From baseline to the 3-month follow-up assessment
Suicide-Related Crisis Service Utilization
Tidsramme: 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.
From baseline to the 3-month follow-up assessment
Change from Baseline to 3-Month Follow-Up in Social Functioning
Tidsramme: 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.
From baseline to the 3-month follow-up assessment
Change from Baseline to 3-Month Follow-Up of Suicide Ideation Severity
Tidsramme: 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.
From baseline to the 3-month follow-up assessment
Change from Baseline to 3-Month Follow-Up in Role Functioning
Tidsramme: 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.
From baseline to the 3-month follow-up assessment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Diego

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

27. juli 2026

Først innsendt som oppfylte QC-kriteriene

6. august 2026

Først lagt ut (Faktiske)

10. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01MH144654 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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