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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Samantha Chalker, PhD
- 電話番号：619-821-9415
- メール：schalker@health.ucsd.edu
研究場所
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-
California
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Los Angeles、California、アメリカ、90095
- University of California, Los Angeles
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コンタクト：
- Carrie Bearden, PhD
- 電話番号：310-206-2983
- メール：cbearden@mednet.ucla.edu
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San Diego、California、アメリカ、92161
- University of California, San Diego
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コンタクト：
- Heline Mirzakhanian, PhD
- 電話番号：619-543-3199
- メール：carelab@health.ucsd.edu
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-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
他の：標準ケア
|
Coordinated speciality care for early psychosis
|
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実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Rate
時間枠：From enrollment to the 3-month follow-up assessment
|
From enrollment to the 3-month follow-up assessment
|
|
|
Retention Rate
時間枠：From enrollment to the 3-month follow-up assessment
|
From enrollment to the 3-month follow-up assessment
|
|
|
Intervention Attendance
時間枠：From enrollment to the end of the intervention at 9 weeks
|
From enrollment to the end of the intervention at 9 weeks
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|
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Acceptability
時間枠：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
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline to 3-Month Follow-Up in Personal Recovery
時間枠：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
時間枠：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
時間枠：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.
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From baseline to the 3-month follow-up assessment
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|
Suicide-Related Crisis Service Utilization
時間枠：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
時間枠：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.
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From baseline to the 3-month follow-up assessment
|
|
Change from Baseline to 3-Month Follow-Up of Suicide Ideation Severity
時間枠：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.
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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
時間枠：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
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- R01MH144654 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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