Suicidal Thought and Biological Markers (STM)

Suicidal Thought and Biological Markers: A Prospective Multicenter Study Validating Verbal, Non-verbal and Genetic Methods to Assess Suicidal Intent

Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.

Study Overview

• Status: Completed
• Conditions: Suicidal Intention

Detailed Description

The purpose of this study is to develop a predictive model that includes Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.

• Study Type: Observational
• Enrollment (Actual): 375

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45229
      • CCHMC
  • West Virginia
    • Princeton, West Virginia, United States, 24740
      • Princeton Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Emergency Department and inpatients

Description

Inclusion Criteria:

oBe able to understand the requirements of the study and provide written informed consent to participate in this study. Signed and dated informed consent will be obtained from each patient before participation in the study, oHave provided written authorization for the use and disclosure of their protected health information, oBe 13 years of age or older, oBe diagnosed with: oSuicide ideation/attempts/gestures, or oNon-suicidal and having other mental disorders, oNon-mentally ill, and non-suicidal controls, oSpeak English as the primary language in the home, oAgree to abide by the study protocol and its restrictions and be able to complete all aspects of the study.

Exclusion Criteria:

oSignificant unstable medical condition that may obscure the scientific interpretability of the study or unduly increase the risks of the protocol, oAnticipated inability to attend follow-up phone interview, oPatients whose level of consciousness precludes consent and research assessments, oPatients unable to assent because of severe mental retardation, oPatients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol, oFor control patients a diagnosis of depression or another non-mental illness, or a history of suicidal behavior or suicidal attempt, oPatients who are unwilling to provide the DNA sample.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Suicidal
Other mental health
Control (non suicidal, non mental health)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Columbia Suicide Severity Rating Scale	Questionnaire	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acoustic analysis of voice	Voice recording	1 month
Video analysis	Video recording	Baseline
DNA analysis	DNA analysis	Baseline

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Study Director: John Pestian, PhD, CCHMC

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: suicide; suicidal intent; thought markers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 20133770