- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02900989
Validation of the French Version of Ask Suicide-Screening Questions (ASQ) in Adolescents Managed in Pediatric Emergency Unit (ASQ-Fr)
Etude de Validation de la Version française d'un Questionnaire " Ask Suicide-Screening Questions " (ASQ) Dans Une Population de Patients Adolescents Pris en Charge en unité d'Urgences pédiatriques
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ASQ-Fr is a prospective, cross-sectional instrument-validation study evaluated 5 candidate screening questions assessing suicide risk in adolescents between 10 and 18 years of age managed in two urban, pediatric emergency departments associated with tertiary care hospitals.
ASQ-Fr questionnaire is conducted by a psychologist before or after the French version of the SIQ/SIQ Junior (Suicidal Ideation Questionnaire), depending on the randomisation in the unit. SIQ is composed of 30 items and valid for adolescents aged 15 years or more. SIQ Junior is composed of 15 items and valid for children up to 14 years old.
Questionnaires are followed by an interview in adolescents and parents separately by the psychologist to evaluate perceptions, feasibility and acceptability of questionnaires.
It is planned a convenience sample of 200 patients aged 10 to 18 years who presented with either medical or surgical chief concerns to the emergency department.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint Pierre, France, 97448
- Centre Hospitalier Universitaire de la Réunion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient with informed consent of adolescents and at least one of parents or a guardian
- patient with social protection cover
- in adequation with emergency management
Exclusion Criteria:
- patients with mental disorder
- minor without parent/gardian at the emergency unit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: ASQ-Fr
Adolescents undergo the ASQ-Fr questionnaire composed of 5 items.
|
Patients of the emergency unit usually do not pass this kind of questionnaire in the absence of warning signs. Then it could result in adverse effects on behavior and ideation. The study had to be declared as an interventional study according to French law. |
|
Other: SIQ-Fr
Adolescents undergo the SIQ-Fr questionnaire composed of 30 items if >=15 yo and the SIQ-Fr Junior composed of 15 items if <15 yo
|
Patients of the emergency unit usually do not pass this kind of questionnaire in the absence of warning signs. Then it could result in adverse effects on behavior and ideation. The study had to be declared as an interventional study according to French law. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of adolescents detected at suicide risk by the French version of Ask Suicide-Screening Questions and by the SIQ or SIQ Junior
Time Frame: 6 months
|
Adolescents are interviewed by the psychologist who administer SIQ/SIQ Junior questionnaire then ASQ or the opposite according to the randomisation process
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type and proportion of answers about perceptions by parents of a questionnaire on suicidal ideation conducted in their child
Time Frame: 6 months
|
Questionnaires are followed by an interview in adolescents and parents separately by the psychologist
|
6 months
|
|
Type and proportion of answers about perceptions by adolescent of the questionnaires
Time Frame: 6 months
|
Questionnaires are followed by an interview in adolescents and parents separately by the psychologist
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Erick Gokalsing, MD, INSERM U1178
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/CHU/01
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