Brief New Treatment for Suicide Attempts
Primary Purpose
Suicide, Attempted, Drug Use, Alcohol; Use, Problem
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief intervention to prevent suicide attempt
Enhanced treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted
Eligibility Criteria
Inclusion Criteria:
- suicide attempt within one week of hospitalization with acknowledgment of some intent to die using a standard item
- problematic alcohol or drug use as determined by score >8 on Alcohol Use Disorders Identification Test, AUDIT or >3 on the 10-item version of the Drug Abuse Screening Test, DAST-10
- admission to hospital
- residence within 40 miles of Strong Memorial Hospital
Exclusion Criteria:
- under age 18
- treated in ED, CPEP, or observation unit only
- unable to communicate with the researcher in English
- unable to comprehend the nature of the study
- participation untenable from a medical (e.g., intubated), psychiatric (e.g., florid psychosis), or behavioral (e.g., refusing to speak with staff) standpoint
- short hospital length of stay, ruling out administering three sessions of the therapy prior to discharge
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
brief intervention to prevent suicide attempt
standard of care
Arm Description
Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
Outcomes
Primary Outcome Measures
suicide reattempt
number who reattempt suicide
Secondary Outcome Measures
Full Information
NCT ID
NCT03300596
First Posted
September 28, 2017
Last Updated
September 15, 2020
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03300596
Brief Title
Brief New Treatment for Suicide Attempts
Official Title
Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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
Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at high risk for reattempt. This treatment development study adapts a promising outpatient intervention to prevent suicide reattempt in order to administer it during hospitalization to individuals with alcohol and drug use problems, and to test the adapted intervention in a pilot randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Drug Use, Alcohol; Use, Problem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brief intervention to prevent suicide attempt
Arm Type
Experimental
Arm Description
Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
Arm Title
standard of care
Arm Type
Other
Arm Description
Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention to prevent suicide attempt
Other Intervention Name(s)
Modification of the Attempted Suicide Short Intervention Program (ASSIP)
Intervention Description
A patient-centered, 3-session intervention that calls for videotaping the narrative story of a patient's suicide attempt, in his/her own words (session 1); reviewing segments of the tape to arrive at a shared understanding of the attempt and the sequence of events that led to it (session 2); and using this information, along with a homework task completed by the patient in-between sessions, in order to develop a collaborative, comprehensive written safety plan that addresses the patient's unique vulnerabilities (session 3).
Intervention Type
Behavioral
Intervention Name(s)
Enhanced treatment as usual
Intervention Description
Safety procedures' control intervention. For these procedures we will share summary results of the research assessments regarding suicidal thoughts, suicidal behaviors, alcohol and drug use and related problems, and depressive symptoms with appropriate hospital clinical staff. We will also arrange to send this information, with participants' permission, to their ongoing therapist or treatment program and, if none exists, to the therapist or program to which they are being referred. In this regard, the research assessment protocol serves a dual function of helping with additional monitoring of high-risk patients in addition to providing data for the study.
Primary Outcome Measure Information:
Title
suicide reattempt
Description
number who reattempt suicide
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suicide attempt within one week of hospitalization with acknowledgment of some intent to die using a standard item
problematic alcohol or drug use as determined by score >8 on Alcohol Use Disorders Identification Test, AUDIT or >3 on the 10-item version of the Drug Abuse Screening Test, DAST-10
admission to hospital
residence within 40 miles of Strong Memorial Hospital
Exclusion Criteria:
under age 18
treated in ED, CPEP, or observation unit only
unable to communicate with the researcher in English
unable to comprehend the nature of the study
participation untenable from a medical (e.g., intubated), psychiatric (e.g., florid psychosis), or behavioral (e.g., refusing to speak with staff) standpoint
short hospital length of stay, ruling out administering three sessions of the therapy prior to discharge
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34304029
Citation
Conner KR, Kearns JC, Esposito EC, Pizzarello E, Wiegand TJ, Britton PC, Michel K, Gysin-Maillart AC, Goldston DB. Pilot RCT of the Attempted Suicide Short Intervention Program (ASSIP) adapted for rapid delivery during hospitalization to adult suicide attempt patients with substance use problems. Gen Hosp Psychiatry. 2021 Sep-Oct;72:66-72. doi: 10.1016/j.genhosppsych.2021.07.002. Epub 2021 Jul 19.
Results Reference
derived
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
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Brief New Treatment for Suicide Attempts
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