Suicide, AttemptedNCT03300596
Brief New Treatment for Suicide Attempts
A study testing Brief intervention to prevent suicide attempt and Enhanced treatment as usual in people with Suicide, Attempted and Drug Use, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Drug Use, Alcohol; Use, Problem
- What is being tested?
- Brief intervention to prevent suicide attempt and Enhanced treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 15 Sep 2020
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
- Conditions
- Suicide, Attempted, Drug Use, Alcohol; Use, Problem
- Being tested
- Brief intervention to prevent suicide attempt, Enhanced treatment as usual
- Medical subject headings
- Suicide, Attempted, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief intervention to prevent suicide attemptBehavioural
Also called Modification of the Attempted Suicide Short Intervention Program (ASSIP)
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).
Enhanced treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| brief intervention to prevent suicide attempt | Experimental | Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem Receives: Behavioral: Brief intervention to prevent suicide attempt |
| standard of care | Other | Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem Receives: Behavioral: Enhanced treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
suicide reattempt
number who reattempt suicide
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 posted3 Oct 2017
- Study start12 Mar 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kenneth Conner, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300596
- Sponsor's protocol ID
- RSRB00069554
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conner KR, Kearns JC, Denneson LM. Qualitative analysis of hospital patient narratives of warning signs on the day of their suicide attempt. Gen Hosp Psychiatry. 2022 Nov-Dec;79:146-151. doi: 10.1016/j.genhosppsych.2022.11.001. Epub 2022 Nov 9.
PubMed 36375343Conner 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.
PubMed 34304029Witt 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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment
- ClinicalTrials.gov ID
- NCT03300596
- Acronym / sponsor ID
- RSRB00069554
- Conditions
- Suicide, Attempted, Drug Use, Alcohol; Use, Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 3 Oct 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brief intervention to prevent suicide attempt | Experimental | Behavioral: Brief intervention to prevent suicide attemptIndividuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem |
| standard of care | Other | Behavioral: Enhanced treatment as usualIndividuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Brief intervention to prevent suicide attemptAlso: Modification of the Attempted Suicide Short Intervention Program (ASSIP)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). | Behavioural | brief intervention to prevent suicide attempt |
| Enhanced treatment as usualSafety 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. | Behavioural | standard of care |
Primary outcome
suicide reattempt
Time frame: 6 months
number who reattempt suicide
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 17 Sep 2020.
- Derived from this study: PubMed 36375343Conner KR, Kearns JC, Denneson LM. Qualitative analysis of hospital patient narratives of warning signs on the day of their suicide attempt. Gen Hosp Psychiatry. 2022 Nov-Dec;79:146-151. doi: 10.1016/j.genhosppsych.2022.11.001. Epub 2022 Nov 9.
- Derived from this study: PubMed 34304029Conner 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.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No
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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 Brief intervention to prevent suicide attempt and Enhanced treatment as usual in people with Suicide, Attempted and Drug Use, run by University of Rochester 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 4 inclusion and 6 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 17 Sep 2020. 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?
suicide reattempt (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300596, which also lists 3 linked publications.
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 17 Sep 2020.