NCT01594138

Brief Summary

The purpose of this study is to determine whether patients who have a high risk for serious suicide behavior will demonstrate a speech pattern that has a relationship to language patterns found in suicide notes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

April 30, 2012

Last Update Submit

February 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differences between questionnaire responses from adolescents with and without suicidal behavior

    At time of questinnaire administration

Study Arms (2)

Suicidal Subjects

Suicidal Subjects

Other: Standardized questionnaires and a ubiquitous questionnaire

Non-Suicidal Control Subjects

Non-Suicidal Control Subjects

Other: Standardized questionnaires and a ubiquitous questionnaire

Interventions

Columbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011)

Non-Suicidal Control SubjectsSuicidal Subjects

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

CCHMC suicidal and non-suicidal adolescents

You may qualify if:

  • Subjects age 13 years 0 months to 17 years, 11 months old
  • Admission to CCHMC ED, psychiatric units, or medical units with suicidal behavior or attempt
  • The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
  • English is spoken as the primary language in the home
  • Subjects age 13 years 0 months to 17 years, 11 months old
  • Admission to CCHMC ED with no current or no history of suicide ideation/attempt/gesture
  • No past or current history of a major mood disorder
  • No history of death by suicide in first-degree relatives
  • The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
  • English is spoken as the primary language in the home

You may not qualify if:

  • Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol
  • Level of consciousness precludes consent and research assessments
  • Unable to assent because of severe mental retardation or incapacitating psychosis
  • Any current or past suicide attempts
  • Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hopsital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • John Pestian, PhD

    Cincinnati Childrens Hospital Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 8, 2012

Study Start

September 1, 2009

Primary Completion

November 1, 2011

Study Completion

July 1, 2014

Last Updated

February 15, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available.

Locations