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Trial record 17 of 1031 for:    Recruiting, Not yet recruiting, Available Studies | "Adolescent"

The Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents (SECURIPLAN)

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ClinicalTrials.gov Identifier: NCT02963870
Recruitment Status : Not yet recruiting
First Posted : November 15, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse prevention.

Since 2009, our team is engaged in a partnership between France and Quebec Interuniversity agreement concluded by a University Picardie Jules Verne-University of Montreal. In this context, two teams G4 (Amiens and Rouen) have received training in suicidal crisis, including the security plan by a university instructor and TCC Québec, Dr. Labelle. Furthermore, we complete a descriptive and prospective study of risk and protective factors for adolescent suicide in which the Quebec team of Professor Labelle contributes as an expert (sponsor: Rouen). 200 subjects were recruited on 2 years by 3 (CHU Amiens, CH Compiègne, CHU Rouen) with an assessment of recurrence at 1 year (lost rates of view = 15%). The first results highlight the central role of personal coping strategies (coping) in suicidal recurrence. We want extend this study to validate the implementation of the security plan (safety level) with suicidal adolescents. The security plan is the initial step of the TCC approach short of suicidal crisis. It is established after working with adolescents and their families (chain analysis of the suicidal crisis, coping self-evaluation and identification of support resources). Developed by Stanley B from Columbia University and adapted for francophone adolescents R Labelle and JJ Breton wrote this list those resources and coping strategies to apply in case ideation and suicidal crisis. Signed by the young person and his family, he then uses to frame the monitoring and management plan of the youth and his family environment, friendly and professional in case of suicidal crisis.


Condition or disease Intervention/treatment
Treatment of Suicidal Recidivism in Adolescents Population Other: Security Plan

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Effectiveness of the Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: security plan
groups of adolescents aged 12-17 hospitalized for TS and randomized to a group treated with security plan and the usual treatment
Other: Security Plan
This study compared two groups of adolescents aged 12-17 hospitalized for TS and randomized to a group treated with the Security Plan plus the usual treatment and a group receiving standard treatment only.
Active Comparator: standard treatment only.
group receiving standard treatment only.
Other: Security Plan
This study compared two groups of adolescents aged 12-17 hospitalized for TS and randomized to a group treated with the Security Plan plus the usual treatment and a group receiving standard treatment only.



Primary Outcome Measures :
  1. Occurrence of suicide attempt [ Time Frame: 12 months ]
    Occurrence of suicide attempt recurrence (documented by CNRS) during the year following randomization.


Secondary Outcome Measures :
  1. Occurrence of relapse Suicide attempt [ Time Frame: 6 months ]
    Occurrence of relapse Suicide attempt within 6 months of randomization.

  2. Observance [ Time Frame: 6 months and 12 months ]
    Observance at 6 months and 1 year using the categories used in the Giraud study

  3. coping strategies of the adolescent [ Time Frame: 12 months ]
    Compare at 1 year the evolution of coping strategies of the adolescent assessed by changes in coping scores assessed by self-questionnaire Friedenberg (ACS) from randomization to 1 year later.

  4. Evolution of social support perceived by the teen evaluat [ Time Frame: 12 months ]
    Compare at 1 year evolution of social support perceived by the teen evaluated by varying the scores of self-questionnaire Sarason (SSQ6) from randomization to 1 year later.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents between 12 and 17, boys and girls, hospitalized for attempted suicide
  • Adolescents whose parents gave informed consent and who themselves expressed their willingness to participate in research.
  • Patients covered by the social insurance system

Exclusion Criteria:

  • Clinical situations with self-injury without suicidal intent or suicide attempt
  • mental disorders significantly impair the self-assessment questionnaire capacities: Intellectual disability, autism spectrum disorder, acute psychotic state and, psychopathy (including assessment questionnaire Frick) and the active use of alcohol and toxic (DEP teen> 20)
  • have benefited a security plan before the study
  • adolescents deprived of liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963870


Contacts
Contact: Jean-Marc GUILE, professor +33 322 087 628 guile.jean-marc@chu-amiens.fr
Contact: AIT AMER MEZIANE Mohamed, PHD +33 322 088 384 aitamermeziane.mohamed@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Director: Jean-Marc GUILE, professor CHU amiens-Picardie
Principal Investigator: LEGRAND, Doctor CHP Philippe Pinel Amiens
Principal Investigator: GERARDIN, Doctor CHU de Rouen
Principal Investigator: BALEYTE, Doctor University Hospital, Caen
Principal Investigator: Bernadette BAKHACHE, Doctor CH St-Quentin
Principal Investigator: Maud PERCQ, Doctor EPSMD Aisne
Principal Investigator: VERVEL, Doctor CH Compiègne

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02963870     History of Changes
Other Study ID Numbers: PI2015_843_0009
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Cognitive behavioral
security plan
suicidal Recidivism in adolescents