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

Primary Purpose

Treatment of Suicidal Recidivism in Adolescents Population

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Security Plan
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Suicidal Recidivism in Adolescents Population focused on measuring Cognitive behavioral, security plan, suicidal Recidivism in adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Amiens PicardieRecruiting
  • CHU CAENRecruiting
  • Chu Charles NicolleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

security plan

standard treatment only.

Arm Description

groups of adolescents aged 12-17 hospitalized for TS and randomized to a group treated with security plan and the usual treatment

group receiving standard treatment only.

Outcomes

Primary Outcome Measures

Occurrence of suicide attempt
Occurrence of suicide attempt recurrence (documented by CNRS) during the year following randomization.

Secondary Outcome Measures

Occurrence of relapse Suicide attempt
Occurrence of relapse Suicide attempt within 6 months of randomization.
Observance
Observance at 6 months and 1 year using the categories used in the Giraud study
coping strategies of the adolescent
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.
Evolution of social support perceived by the teen evaluat
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.

Full Information

First Posted
November 10, 2016
Last Updated
August 3, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02963870
Brief Title
The Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents
Acronym
SECURIPLAN
Official Title
Randomized Controlled Trial of the Effectiveness of the Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Suicidal Recidivism in Adolescents Population
Keywords
Cognitive behavioral, security plan, suicidal Recidivism in adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
security plan
Arm Type
Experimental
Arm Description
groups of adolescents aged 12-17 hospitalized for TS and randomized to a group treated with security plan and the usual treatment
Arm Title
standard treatment only.
Arm Type
Active Comparator
Arm Description
group receiving standard treatment only.
Intervention Type
Other
Intervention Name(s)
Security Plan
Intervention Description
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 Measure Information:
Title
Occurrence of suicide attempt
Description
Occurrence of suicide attempt recurrence (documented by CNRS) during the year following randomization.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Occurrence of relapse Suicide attempt
Description
Occurrence of relapse Suicide attempt within 6 months of randomization.
Time Frame
6 months
Title
Observance
Description
Observance at 6 months and 1 year using the categories used in the Giraud study
Time Frame
6 months and 12 months
Title
coping strategies of the adolescent
Description
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.
Time Frame
12 months
Title
Evolution of social support perceived by the teen evaluat
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc GUILE, professor
Phone
+33 322 087 628
Email
guile.jean-marc@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
AIT AMER MEZIANE Mohamed, PHD
Phone
+33 322 088 384
Email
aitamermeziane.mohamed@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc GUILE, professor
Organizational Affiliation
CHU amiens-Picardie
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
LEGRAND, Doctor
Organizational Affiliation
CHP Philippe Pinel Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GERARDIN, Doctor
Organizational Affiliation
CHU de Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BALEYTE, Doctor
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernadette BAKHACHE, Doctor
Organizational Affiliation
CH St-Quentin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maud PERCQ, Doctor
Organizational Affiliation
EPSMD Aisne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
VERVEL, Doctor
Organizational Affiliation
CH Compiègne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens Picardie
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-marc GUILE, PhD
First Name & Middle Initial & Last Name & Degree
Sébatien GARNY DE LA RIVIERE, Dr
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-marc BALEYTE, PhD
First Name & Middle Initial & Last Name & Degree
Solène SPIERS, Dr
Facility Name
Chu Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscille GERARDIN, PhD
First Name & Middle Initial & Last Name & Degree
Malaika Lasfar, Dr
First Name & Middle Initial & Last Name & Degree
Agathe Raynal, Dr

12. IPD Sharing Statement

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

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