- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Samantha Chalker, PhD
- Numéro de téléphone: 619-821-9415
- E-mail: schalker@health.ucsd.edu
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095
- University of California, Los Angeles
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Contact:
- Carrie Bearden, PhD
- Numéro de téléphone: 310-206-2983
- E-mail: cbearden@mednet.ucla.edu
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San Diego, California, États-Unis, 92161
- University of California, San Diego
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Contact:
- Heline Mirzakhanian, PhD
- Numéro de téléphone: 619-543-3199
- E-mail: carelab@health.ucsd.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Soins standards
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Coordinated speciality care for early psychosis
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Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment Rate
Délai: From enrollment to the 3-month follow-up assessment
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From enrollment to the 3-month follow-up assessment
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Retention Rate
Délai: From enrollment to the 3-month follow-up assessment
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From enrollment to the 3-month follow-up assessment
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|
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Intervention Attendance
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline to 3-Month Follow-Up in Personal Recovery
Délai: 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
Délai: From baseline to the 3-month follow-up assessment
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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From baseline to the 3-month follow-up assessment
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Spectre de la schizophrénie et autres troubles psychotiques
- Les troubles mentaux
- Symptômes comportementaux
- Comportement d'automutilation
- Comportement
- Troubles psychotiques
- Suicide
- Idéation suicidaire
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- R01MH144654 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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