Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03227991
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2016-12-15
Brief Title:
Safety Planning Intervention to Reduce Short Term Risk
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Safety Planning Intervention to Reduce Short Term Risk
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the efficacy of Safety Planning Intervention SPI compared to receiving risk factors and warning sign information RWI in recent suicide attempters during the 6 months following an acute care visit on 1 suicidal behaviors 2 mental healthsubstance use treatment engagement 3 suicide-related coping strategies 4 suicidal ideation and 5 use of means restriction
Detailed Description:
There is a pressing need for improved acute care setting suicide prevention interventions The Safety Planning Intervention SPI is a protocol driven brief suicide prevention strategy that is a good fit for acute care settings ie emergency departments ED and inpatient units The SPI involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification means restriction and personalized strategies to deescalate a suicide crisis It is easy to learn and administer acceptable to patients brief firmly rooted in an empirical base and has preliminary studies supporting its feasibility and potential to impact patient outcomes including suicidal behavior and treatment engagement However while it is being adopted widely it lacks a randomized controlled trial RCT to definitively determine its efficacy The purpose of this study to conduct a randomized control trial of the Safety Planning Intervention SPI compared with receiving risk factors and warning sign information RWI in acute care settings
All participants in this study will complete some baseline assessments following which they will be randomly assigned to one of two study conditions Safety Plan Intervention SPI or receiving risk factors and warning sign information RWI If assigned to SPI participants will receive the assigned intervention by the research clinician They will receive a paper copy of their safety plan while in the ED or on the inpatient unit and a back-up copy will be sent approximately 1 week after discharge to participants For RWI participants ED and inpatient unit care will be delivered as usual with the addition of a printed information sheet listing suicide risk factors and crisis hotlines In addition to the baseline assessment multi-method outcome assessment will be conducted at 1 3 and 6 months This will include telephone evaluations by a blinded assessor not the research clinician medical record review and vital statistics registry review
All participants in this study will complete some baseline assessments following which they will be randomly assigned to one of two study conditions Safety Plan Intervention SPI or receiving risk factors and warning sign information RWI If assigned to SPI participants will receive the assigned intervention by the research clinician They will receive a paper copy of their safety plan while in the ED or on the inpatient unit and a back-up copy will be sent approximately 1 week after discharge to participants For RWI participants ED and inpatient unit care will be delivered as usual with the addition of a printed information sheet listing suicide risk factors and crisis hotlines In addition to the baseline assessment multi-method outcome assessment will be conducted at 1 3 and 6 months This will include telephone evaluations by a blinded assessor not the research clinician medical record review and vital statistics registry review
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None