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Trial record 1 of 1 for:    NCT01707576
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Screening of Adolescent Mental Suffering (DESPERADOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01707576
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : April 4, 2016
Sponsor:
Collaborators:
Pfizer
Fondation de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE October 12, 2012
First Posted Date  ICMJE October 16, 2012
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
Responses to Self-reported questionnaire on risk behaviors, somatic complaints by adolescents and parents [ Time Frame: 10 months ]
A self-questionnaire ADRS (Adolescent Depression Rating Scale) will be asked to all adolescents to complete. Also the other questions will be answered by them concenrning somatisations and risk behaviors. Parents respond in the same time a self questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
Post-emergency consultation and reassessment of hetero-ADRS clinician questionnaire [ Time Frame: 6 months ]
Actual presence of adolescents suspected of depression at the post-emergency consultation and reassessment of their state using the hetero-ADRS-clinician questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2012)
Revaluation after one year [ Time Frame: 6 months ]
Revaluation after 1 year of the teenagers who come back to visit.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Screening of Adolescent Mental Suffering
Official Title  ICMJE SCREENING OF ADOLESCENT MENTAL SUFFERING CONSULTANT TO EMERGENCIES, MANAGEMENT AND Later MONITORING
Brief Summary

The primary purpose is to estimate the prevalence of depression and subsyndromal states among adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they are another way of tracking this suffering, as they host many troubled teens at once for health problems and accidents sometimes iterative, reflecting their risk behaviour.

Secondary purposes are to assess the feasibility and desirability of a post-emergency medical consultation for adolescents who scored high on a self-administered questionnaire, and to assess the impact of this approach by later monitoring.

Detailed Description

This is a multicenter longitudinal survey in three emergency centers in Ile-de-France, with 2 periods of daily collection and comprehensive three weeks spread over one year, followed by a remote evaluation.

The project is as follows:

Phase A :

- Evaluation of the prevalence: systematic execution of self-administered questionnaire by all adolescents consulting, night and day in each center.

Phase B :

  • For adolescents whose outcome questionnaire exceed 4, a post-emergency consultation will be proposed within 15 days.
  • Telephone survey, 12 months after the passage of emergency every teenager who completed self-administered questionnaire and presenting himself to the post-emergency consultation. This survey will aim to assess the psychological status of adolescents and the impact of any specific treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Depression
  • Adolescent
  • Self-report Questionnaire
Intervention  ICMJE Behavioral: consultation 10 days later
new depression screening
Study Arms  ICMJE screening of adolescent mental suffering. Management
screening of adolescent mental suffering consultant to emergencies. Management and later monitoring
Intervention: Behavioral: consultation 10 days later
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2012)
346
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescents over the age of 13 to 17 years when passing emergency whatever the reason for consultation (surgical or medical, including attempted suicide or psychological problem)

Exclusion Criteria:

  • Young people not reading French.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01707576
Other Study ID Numbers  ICMJE P090103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Pfizer
  • Fondation de France
Investigators  ICMJE
Principal Investigator: Chantal Stheneur, MD Ambroise Paré University Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP