SuicideCLASPNCT02313753
Evaluation of the Coping Long Term With Active Suicide Program
A study testing CLASP and SAFE in people with Suicide, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- CLASP and SAFE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 31 Mar 2021
- 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
- Current patient at Butler Hospital
- Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS
- Age > 18 years
- Have a reliable telephone
- Ability to speak, read, and understand English well to complete the procedures of the study
Who cannot join
- Current psychotic symptoms severe enough to impair study participation
- Participation in a treatment program with established efficacy in preventing suicidal behavior
- Cognitive impairment which would interfere with adequate participation in the project (MMSE< 20).
- 4. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.
- Conditions
- Suicide
- Being tested
- CLASP, SAFE
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLASPBehavioural
SAFEBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SAFE | Active comparator | Safety Assessment and Follow-up Evaluation Protocol Receives: Behavioral: SAFE |
| CLASP | Experimental | Coping Long Term with Active Suicide Program Protocol Receives: Behavioral: CLASP |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite composed of the number of participants with either a suicide attempt or death by suicide
As assessed by both the Columbia Suicide Severity Rating Scale and record review
Measured: 52 weeks following discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Miller, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313753
- Sponsor's protocol ID
- MH101129
- Acronym
- CLASP
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2014
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Coping Long Term With Active Suicide Program
- ClinicalTrials.gov ID
- NCT02313753
- Acronym / sponsor ID
- CLASP / MH101129
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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 purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE | Active comparator | Behavioral: SAFESafety Assessment and Follow-up Evaluation Protocol |
| CLASP | Experimental | Behavioral: CLASPCoping Long Term with Active Suicide Program Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current patient at Butler Hospital
- Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS
- Age > 18 years
- Have a reliable telephone
- Ability to speak, read, and understand English well to complete the procedures of the study
Key exclusion criteria (4 listed)
- Current psychotic symptoms severe enough to impair study participation
- Participation in a treatment program with established efficacy in preventing suicidal behavior
- Cognitive impairment which would interfere with adequate participation in the project (MMSE< 20).
- 4. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial
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 |
|---|---|---|
| CLASP | Behavioural | CLASP |
| SAFE | Behavioural | SAFE |
Primary outcome
A composite composed of the number of participants with either a suicide attempt or death by suicide
Time frame: 52 weeks following discharge from hospital
As assessed by both the Columbia Suicide Severity Rating Scale and record review
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 7 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLASP and SAFE in people with 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 4 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 7 Jun 2021. 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?
A composite composed of the number of participants with either a suicide attempt or death by suicide (time frame: 52 weeks following discharge from hospital). 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 7 Jun 2021; AzTrials last refreshed its copy on 28 Oct 2026.