SchizophreniaCLASP-SNCT04221269
Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders
A study testing Enhanced Treatment as Usual and Coping Long-term with Active Suicide Program for Schizophrenia in people with Schizophrenia and Suicide, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Suicide
- What is being tested?
- Enhanced Treatment as Usual and Coping Long-term with Active Suicide Program for Schizophrenia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suicidal thoughts or behaviors prior to hospital admission
- diagnosis of a schizophrenia-spectrum disorder
- receiving pharmacotherapy
- 18 years or older
- speaks/reads English
Who cannot join
- psychosis due to substance use or medical condition
- lack of phone access
- discharge to long-term facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Schizophrenia, Suicide
- Being tested
- Enhanced Treatment as Usual, Coping Long-term with Active Suicide Program for Schizophrenia
- Keywords
- psychiatric hospitalization, suicide prevention, psychosis, psychosocial intervention
- Medical subject headings
- Schizophrenia, Suicide, Suicide Prevention, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Treatment as UsualBehavioural
Routine community care plus assessment feedback reports to clinicians.
Coping Long-term with Active Suicide Program for SchizophreniaBehavioural
Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Treatment as Usual | Active comparator | 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. Receives: Behavioral: Enhanced Treatment as Usual |
| Coping Long-term with Active Suicide Program for Schizophrenia | Experimental | 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. Receives: Behavioral: Enhanced Treatment as Usual; Behavioral: Coping Long-term with Active Suicide Program for Schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Dec 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Sponsor
- Investigators
- Brandon Gaudiano, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221269
- Sponsor's protocol ID
- 1908-001
- Acronym
- CLASP-S
- Status last verified
- Jul 2023
- First submitted
- 6 Jan 2020
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders
- ClinicalTrials.gov ID
- NCT04221269
- Acronym / sponsor ID
- CLASP-S / 1908-001
- Conditions
- Schizophrenia, Suicide
- Keywords
- psychiatric hospitalization, suicide prevention, psychosis, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Treatment as Usual | Active comparator | Behavioral: Enhanced Treatment as UsualParticipants 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 | Experimental | Behavioral: Enhanced Treatment as Usual, Behavioral: Coping Long-term with Active Suicide Program for SchizophreniaCoping 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- suicidal thoughts or behaviors prior to hospital admission
- diagnosis of a schizophrenia-spectrum disorder
- receiving pharmacotherapy
- 18 years or older
- speaks/reads English
Key exclusion criteria (3 listed)
- psychosis due to substance use or medical condition
- lack of phone access
- discharge to long-term facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Treatment as UsualRoutine community care plus assessment feedback reports to clinicians. | Behavioural | Coping Long-term with Active Suicide Program for Schizophrenia, Enhanced Treatment as Usual |
| Coping Long-term with Active Suicide Program for SchizophreniaAdjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions. | Behavioural | Coping Long-term with Active Suicide Program for Schizophrenia |
Primary outcome
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.
1 secondary outcome
Columbia Suicide Severity Rating Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Gaudiano, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Treatment as Usual and Coping Long-term with Active Suicide Program for Schizophrenia in people with Schizophrenia and Suicide, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.