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

Randomized Controlled Trial of the Effectiveness of the Cognitive-behavioral Approach, Standard Plan Security on Relapse Suicidal Adolescents

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

Study Overview

• Status: Unknown
• Conditions: Treatment of Suicidal Recidivism in Adolescents Population
• Intervention / Treatment: Other: Security Plan

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.

• Study Type: Interventional
• Enrollment (Anticipated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Marc GUILE, professor; Phone Number: +33 322 087 628; Email: guile.jean-marc@chu-amiens.fr
• Study Contact Backup: Name: AIT AMER MEZIANE Mohamed, PHD; Phone Number: +33 322 088 384; Email: aitamermeziane.mohamed@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Jean-marc GUILE, PhD
    • Sub-Investigator: Sébatien GARNY DE LA RIVIERE, Dr
  • Caen, France, 14000
    • Recruiting
    • CHU caen
    • Contact: Jean-marc BALEYTE, PhD
    • Sub-Investigator: Solène SPIERS, Dr
  • Rouen, France, 76000
    • Recruiting
    • CHU Charles Nicolle
    • Contact: Priscille GERARDIN, PhD
    • Sub-Investigator: Malaika Lasfar, Dr
    • Sub-Investigator: Agathe Raynal, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of suicide attempt	Occurrence of suicide attempt recurrence (documented by CNRS) during the year following randomization.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of relapse Suicide attempt	Occurrence of relapse Suicide attempt within 6 months of randomization.	6 months
Observance	Observance at 6 months and 1 year using the categories used in the Giraud study	6 months and 12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Cognitive behavioral; security plan; suicidal Recidivism in adolescents
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: PI2015_843_0009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No