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

2026년 8월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

108

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • California
      • Los Angeles, California, 미국, 90095
        • University of California, Los Angeles
        • 연락하다:
      • San Diego, California, 미국, 92161
        • University of California, San Diego
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 스탠다드 케어
Coordinated speciality care for early psychosis
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment Rate
기간: From enrollment to the 3-month follow-up assessment
From enrollment to the 3-month follow-up assessment
Retention Rate
기간: From enrollment to the 3-month follow-up assessment
From enrollment to the 3-month follow-up assessment
Intervention Attendance
기간: From enrollment to the end of the intervention at 9 weeks
From enrollment to the end of the intervention at 9 weeks
Acceptability
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline to 3-Month Follow-Up in Personal Recovery
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 7월 27일

QC 기준을 충족하는 최초 제출

2026년 8월 6일

처음 게시됨 (실제)

2026년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 10일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • R01MH144654 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .