Disruptive BehaviorTRAJECTORYNCT02828969
Clinical and Social Trajectory of Children and Adolescents With Disruptive Behavior
A study testing Phone call or physical consultation in people with Disruptive Behavior, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Disruptive Behavior
- What is being tested?
- Phone call or physical consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon/bron, 69500
Yannis GANSEL, MD, 4.72.12.95.62 ext. +33, yannis.gansel@chu-lyon.fr
Sonia GALLETTI, CRA, 427857739 ext. +33, sonia.galletti@chu-lyon.fr
About this study
Official title: 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.
- Conditions
- Disruptive Behavior
- Being tested
- Phone call or physical consultation
- Keywords
- Trajectory, Emergency room, Conduct disorder, Care management
- Medical subject headings
- Problem Behavior, Emergencies, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call or physical consultationOther
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents with conduct disorders | Other | Girls and boys having less than 18 years old and admitted to emergency room for aggressiveness, violence, fugue or theft. Receives: Other: Phone call or physical consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft.
This study is intended to characterized the population of children and adolescents admitted to emergency rooms for disruptive behavior
Measured: At inclusion
Secondary outcomes (9)
Nature and type of the care management provided to children and adolescents admitted to emergency rooms for disruptive behavior
Type of care management (hospitalization, reason of admission, type of caregiver at the admission, perception of the care management…)
Measured: At inclusion
description of patients' perceptions of the care management
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.
Measured: at inclusion
description of patients' perceptions of the care management
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.
Measured: 6 months
description of patients' perceptions of the care management
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.
Measured: 12 months
description of patients' perceptions of the care management
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.
Measured: 24 months
Identification of patients'psychiatric underlying disorders
The patients'psychiatric underlying disorders will be evaluated by Psychiatric diagnosis : criteria of ICD (International Classification of Diseases) 10
Measured: At 6 months
Social and clinical evolution after the initial admission to emergency room
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….
Measured: 6 months
Social and clinical evolution after the initial admission to emergency room
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….
Measured: 12 months
Social and clinical evolution after the initial admission to emergency room
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….
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive BehaviorStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828969
- Sponsor's protocol ID
- 69HCL16_0432
- Acronym
- TRAJECTORY
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trajectory of Children and Adolescents With Disruptive Behavior Admitted to Pediatric and Psychiatric Emergencies.
- ClinicalTrials.gov ID
- NCT02828969
- Acronym / sponsor ID
- TRAJECTORY / 69HCL16_0432
- Conditions
- Disruptive Behavior
- Keywords
- Trajectory, Emergency room, Conduct disorder, Care management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with conduct disorders | Other | Other: Phone call or physical consultationGirls and boys having less than 18 years old and admitted to emergency room for aggressiveness, violence, fugue or theft. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone call or physical consultation | Other | Children and adolescents with conduct disorders |
Primary outcome
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
9 secondary outcomes
Nature and type of the care management provided to children and adolescents admitted to emergency rooms for disruptive behavior
Time frame: At inclusion
description of patients' perceptions of the care management
Time frame: at inclusion
description of patients' perceptions of the care management
Time frame: 6 months
description of patients' perceptions of the care management
Time frame: 12 months
description of patients' perceptions of the care management
Time frame: 24 months
Identification of patients'psychiatric underlying disorders
Time frame: At 6 months
Social and clinical evolution after the initial admission to emergency room
Time frame: 6 months
Social and clinical evolution after the initial admission to emergency room
Time frame: 12 months
Social and clinical evolution after the initial admission to emergency room
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call or physical consultation in people with Disruptive Behavior, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannis GANSEL, MD (4.72.12.95.62 ext. +33, yannis.gansel@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft. (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.