Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders (CLASP-S)

Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Suicide
• Intervention / Treatment: Behavioral: Enhanced Treatment as Usual; Behavioral: Coping Long-term with Active Suicide Program for Schizophrenia

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheryl Cordeira; Phone Number: 401-455-6654; Email: CCordeiro@butler.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• suicidal thoughts or behaviors prior to hospital admission
• diagnosis of a schizophrenia-spectrum disorder
• receiving pharmacotherapy
• 18 years or older
• speaks/reads English

Exclusion Criteria:

• psychosis due to substance use or medical condition
• lack of phone access
• discharge to long-term facility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Enhanced Treatment as Usual; Routine community care plus assessment feedback reports to clinicians.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Columbia Suicide Severity Rating Scale	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.	6 months

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: American Foundation for Suicide Prevention
• Investigators: Principal Investigator: Brandon Gaudiano, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: psychosis; psychosocial intervention; suicide prevention; psychiatric hospitalization
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Self-Injurious Behavior; Schizophrenia; Suicide; Suicide Prevention
• Other Study ID Numbers: 1908-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No