- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300596
Brief New Treatment for Suicide Attempts
September 15, 2020 updated by: Kenneth Conner, University of Rochester
Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: brief intervention to prevent suicide attempt
Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
|
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).
Other Names:
|
|
Other: standard of care
Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
suicide reattempt
Time Frame: 6 months
|
number who reattempt suicide
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2018
Primary Completion (Actual)
September 15, 2020
Study Completion (Actual)
September 15, 2020
Study Registration Dates
First Submitted
September 28, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (Actual)
October 3, 2017
Study Record Updates
Last Update Posted (Actual)
September 17, 2020
Last Update Submitted That Met QC Criteria
September 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSRB00069554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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