- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02828969
Clinical and Social Trajectory of Children and Adolescents With Disruptive Behavior (TRAJECTORY)
Clinical Trajectory of Children and Adolescents With Disruptive Behavior Admitted to Pediatric and Psychiatric Emergencies.
Conduct disorders are defined as "repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms are violated". So defined, these disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder management is a public health issue and a societal question. Conduct disorders affect 5 to 9% of 15-year old boys.
Care management of children and adolescents admitted for disruptive behaviors in emergency rooms is an issue. No consensus or official recommendation exists. However, use of emergency care in this context is increasing in most western countries and it exposes to several risks (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and suicide risk). The Trajectories project is designed to describe children and adolescents with disruptive behaviors, their care management and to follow their life trajectory and psychiatric evolution after admission to emergency rooms. Better understanding this population will improve their medical and social care management, thereby giving professionals the right tools.
The main objective of this project is to implement a multidisciplinary and integrative research combining clinical considerations and social sciences to determine the "trajectory" of this population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yannis GANSEL, MD
- Phone Number: +33 4.72.12.95.62
- Email: yannis.gansel@chu-lyon.fr
Study Contact Backup
- Name: Sonia GALETTI, CRA
- Phone Number: +33 427857739
- Email: sonia.galetti@chu-lyon.fr
Study Locations
-
-
-
Lyon/bron, France, 69500
- Recruiting
- Hospices Civils de Lyon
-
Contact:
- Yannis GANSEL, MD
- Phone Number: +33 4.72.12.95.62
- Email: yannis.gansel@chu-lyon.fr
-
Contact:
- Sonia GALLETTI, CRA
- Phone Number: +33 427857739
- Email: sonia.galletti@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
Exclusion Criteria:
- Children and adolescents admitted to emergency rooms for a reason not directly link with aggressiveness, violence, fugue or theft
- Opposition to the subject or the family to participate to this research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Children and adolescents with conduct disorders
Girls and boys having less than 18 years old and admitted to emergency room for aggressiveness, violence, fugue or theft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft.
Time Frame: At inclusion
|
This study is intended to characterized the population of children and adolescents admitted to emergency rooms for disruptive behavior
|
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nature and type of the care management provided to children and adolescents admitted to emergency rooms for disruptive behavior
Time Frame: At inclusion
|
Type of care management (hospitalization, reason of admission, type of caregiver at the admission, perception of the care management…)
|
At inclusion
|
description of patients' perceptions of the care management
Time Frame: at inclusion
|
the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies.
|
at inclusion
|
description of patients' perceptions of the care management
Time Frame: 6 months
|
the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies.
|
6 months
|
description of patients' perceptions of the care management
Time Frame: 12 months
|
the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies.
|
12 months
|
description of patients' perceptions of the care management
Time Frame: 24 months
|
the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies.
|
24 months
|
Identification of patients'psychiatric underlying disorders
Time Frame: At 6 months
|
The patients'psychiatric underlying disorders will be evaluated by Psychiatric diagnosis : criteria of ICD (International Classification of Diseases) 10
|
At 6 months
|
Social and clinical evolution after the initial admission to emergency room
Time Frame: 6 months
|
The social evolution will be evaluated by social rupture, exclusion, penal measure and the clinical evolution will be evaluated by suicide attempt, disruptive behavior recurrence….
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6 months
|
Social and clinical evolution after the initial admission to emergency room
Time Frame: 12 months
|
The social evolution will be evaluated by social rupture, exclusion, penal measure and the clinical evolution will be evaluated by suicide attempt, disruptive behavior recurrence….
|
12 months
|
Social and clinical evolution after the initial admission to emergency room
Time Frame: 24 months
|
The social evolution will be evaluated by social rupture, exclusion, penal measure and the clinical evolution will be evaluated by suicide attempt, disruptive behavior recurrence….
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0432
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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