NCT03894462

Brief Summary

Effective, brief, low-cost interventions for individuals who attempt suicide are needed to save lives and achieve the goals of the National Strategy for Suicide Prevention. In response to a National Institute for Mental Health (NIMH) Notice of Interest, this time-sensitive proposal leverages an existing federal investment in Zero Suicide to test the effectiveness of a highly promising new treatment for recent suicide attempt survivors and learn how it works. If hypotheses are supported, the study will provide evidence of a brief, practical, and cost-effective therapy that reduces suicide reattempts in a real-world health setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 6, 2025

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

February 12, 2019

Last Update Submit

April 2, 2025

Conditions

Keywords

Zero SuicideEffectivenessBrief TreatmentInterpersonal TheoryCost-Effectiveness

Outcome Measures

Primary Outcomes (1)

  • Time to Suicide Attempt

    Time from randomization to first suicide re-attempt

    Up to 18 months

Study Arms (2)

Zero Suicide Usual Care

ACTIVE COMPARATOR

In Onondaga County, New York State (NYS) aims to implement a countywide "Zero Suicide Safety Net" of providers who share enhanced protocols for clinical care, staff training, and data collection (improved coding of suicidal behavior). Participating behavioral health systems have agreed to common protocols for clinical care, training, and data collection. Participating providers receive robust training in suicide prevention best practices. Because of the wide participation of mental health facilities in the NYS Office of Mental Health (OMH) Zero Suicide project, most subjects who engage in outpatient treatment will receive that treatment in facilities that are adopting NYS Zero Suicide protocols. Those who do not engage in care will nonetheless experience enhanced transition and follow-up contact from the services from which they are discharged.

Behavioral: Zero Suicide Usual Care

Zero Suicide Usual Care + ASSIP

EXPERIMENTAL

Patients in this treatment arm will receive ASSIP brief therapy in addition to being able to access any usual care as recommended by their provider. ASSIP is a manualized, three-session intervention, delivered either in-person or via telehealth: In Session 1, the therapist guides the patient in telling the story of their attempt. The session is video recorded. In Session 2, the therapist and patient sit side-by-side to view selections of the video, working together to understand the feelings and events that preceded the attempt. The patient is assigned a homework task. In Session 3, the therapist and patient create a summary of the suicide attempt and what led up to it, along with creating a personal safety plan.

Behavioral: Attempted Suicide Short Intervention Program

Interventions

ASSIP is a manualized, three-session intervention, delivered either in-person or via telehealth: In Session 1, the therapist guides the patient in telling the story of their attempt. The session is video recorded. In Session 2, the therapist and patient sit side-by-side to view selections of the video, working together to understand the feelings and events that preceded the attempt. The patient is assigned a homework task. In Session 3, the therapist and patient create a summary of the suicide attempt and what led up to it, along with creating a personal safety plan.

Zero Suicide Usual Care + ASSIP

Participants will have access to outpatient treatment in facilities that are adopting NYS Zero Suicide protocols. Those who do not engage in care will nonetheless experience enhanced transition and follow-up contact from the services from which they are discharged.

Zero Suicide Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older.
  • Suicide attempt within the past 60 days defined by intent to die using a standard item.
  • Ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up.

You may not qualify if:

  • Acute psychiatric instability (e.g., psychotic symptoms).
  • Inability to communicate in English (ASSIP is only provided by the clinic in English).
  • Residing outside of NYS (during the period eligible for ASSIP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Rochester Medical Center

Rochester, New York, 14604, United States

Location

St. Joseph's Health Hospital

Syracuse, New York, 13203, United States

Location

Upstate University Hospital

Syracuse, New York, 13210, United States

Location

Related Publications (3)

  • Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med. 2016 Mar 1;13(3):e1001968. doi: 10.1371/journal.pmed.1001968. eCollection 2016 Mar.

    PMID: 26930055BACKGROUND
  • Pisani A, Connor K, Van Orden K, Jordan N, Landes S, Curran G, McDermott M, Ertefaie A, Kelberman C, Ramanathan S, Carruthers J, Mossgraber K, Goldston D. Effectiveness of a targeted brief intervention for recent suicide attempt survivors: a randomised controlled trial protocol. BMJ Open. 2023 Mar 3;13(3):e070105. doi: 10.1136/bmjopen-2022-070105.

  • 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.

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
We do not inform providers giving usual care whether their patients are receiving ASSIP. However, providers may find out through ordinary course of usual care being provided.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 28, 2019

Study Start

April 1, 2021

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

April 6, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations