The current project is a pilot randomized controlled trial to test the Coping Long-term with Active Suicide Program for schizophrenia-spectrum disorders (CLASP-S) for patients following a psychiatric hospitalization. Participants will be assigned to enhanced treatment as usual (ETAU) alone vs CLASP-S plus ETAU. Participants complete assessments at baseline during their psychiatric hospitalization and at 3 months (mid-treatment) and 6 months (post-treatment) following discharge. The primary aim is to assess the feasibility and acceptability of CLASP-S. The secondary aim is to estimate the effects of CLASP-S on reducing suicidal thoughts and behaviors relative to ETAU.
Full Title of Study: “Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: October 1, 2021
- Behavioral: Enhanced Treatment as Usual
- Routine community care plus assessment feedback reports to clinicians.
- Behavioral: Coping Long-term with Active Suicide Program for Schizophrenia
- Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.
Arms, Groups and Cohorts
- Active Comparator: Enhanced Treatment as Usual
- Participants assigned to Enhanced Treatment as Usual (ETAU) alone will receive unrestricted routine care in the community. Assessment feedback reports will be sent to participants’ community providers at baseline, 3 months, and 6 months for care coordination.
- Experimental: Coping Long-term with Active Suicide Program for Schizophrenia
- Coping Long-term with Active Suicide Program for Schizophrenia-Spectrum Disorders (CLASP-S) includes 3 individual sessions, 1 family meeting, and 11 phone sessions with the participant and their significant other over 6 months post-hospital discharge.
Clinical Trial Outcome Measures
- Client Satisfaction Questionnaire
- Time Frame: 6 months
- The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
- Columbia Suicide Severity Rating Scale
- Time Frame: 6 months
- The Columbia Suicide Severity Rating Scale is an interviewer-rated measure of suicidal thoughts and behaviors. The total score (sum of items) will be used and ranges from 2 to 25 with higher scores indicating higher suicidal thoughts and behaviors.
Participating in This Clinical Trial
- suicidal thoughts or behaviors prior to hospital admission
- diagnosis of a schizophrenia-spectrum disorder
- receiving pharmacotherapy
- 18 years or older
- speaks/reads English
- psychosis due to substance use or medical condition
- lack of phone access
- discharge to long-term facility
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Butler Hospital
- American Foundation for Suicide Prevention
- Provider of Information About this Clinical Study
- Overall Official(s)
- Brandon Gaudiano, PhD, Principal Investigator, Butler Hospital
- Overall Contact(s)
- Cheryl Cordeira, 401-455-6654, CCordeiro@butler.org
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