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

Primary Purpose

Schizophrenia, Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Treatment as Usual
Coping Long-term with Active Suicide Program for Schizophrenia
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring psychiatric hospitalization, suicide prevention, psychosis, psychosocial intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Treatment as Usual

Coping Long-term with Active Suicide Program for Schizophrenia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 6, 2020
Last Updated
July 10, 2023
Sponsor
Butler Hospital
Collaborators
American Foundation for Suicide Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04221269
Brief Title
Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders
Acronym
CLASP-S
Official Title
Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
American Foundation for Suicide Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Suicide
Keywords
psychiatric hospitalization, suicide prevention, psychosis, psychosocial intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Coping Long-term with Active Suicide Program for Schizophrenia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual
Intervention Description
Routine community care plus assessment feedback reports to clinicians.
Intervention Type
Behavioral
Intervention Name(s)
Coping Long-term with Active Suicide Program for Schizophrenia
Intervention Description
Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders

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