Disruptive Behavior DisorderTRAJECTORIESNCT02812537
Clinical and Social Trajectories of Children and Adolescents With Disruptive Behavior
An observational study of Disruptive Behavior Disorder, 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 Up to 16 years
- Conditions the study is for
- Disruptive Behavior Disorder
- What is being tested?
- patients with conduct disorders
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2019to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents admitted to emergency rooms for conduct disorder (aggressiveness, violence, fugue or theft)
Who may be able to join
- Children and adolescents less than 16 years old
- 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. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Bron, 69677
Yannis Gansel, MD
About this study
Official title: Clinical and Social Trajectories of Children and Adolescents With Disruptive Behavior: Multidisciplinary Approach of Pediatric and Psychiatric Emergencies in the Rhône-Alpes Auvergne Region
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 Disorder
- Being tested
- patients with conduct disorders
- Keywords
- Trajectories, emergency room, conduct disorder, care management
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Emergencies, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with conduct disordersOther
interview with a specialist
| Study group | Role | What they receive |
|---|---|---|
| patients with conduct disorders | Girls and boys having less than 16 years old and admitted to emergency room for aggressiveness, violence, fugue or theft. Receives: Other: patients with conduct disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new admissions to emergency rooms for aggressiveness, violence, fugue or theft
Six months follow-up of these children and adolescents in their future trajectory after the first admission to emergency room for disruptive behavior
Measured: 6 months
Secondary outcomes (11)
Age of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
mean age
Measured: Day 0
Gender of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
Measured: Day 0
Number of children and adolescents precisely diagnosed with " behavior/conduct disorder
Measured: Day 0
Number of hospitalization
following the admission
Measured: Day 0
number of patients admitted to emergency rooms for aggressiveness
Measured: Day 0
number of patients admitted to emergency rooms for violence
Measured: Day 0
number of patients admitted to emergency rooms for fugue
Measured: Day 0
number of patients admitted to emergency rooms for theft
Measured: Day 0
number of suicide attempts
Measured: 24 months
number of patients with disruptive behavior recurrence
Measured: 24 months
evolution of the CBCL score
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 posted24 Jun 2016 (estimated)
- Study start20 May 2019
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Behavior DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannis Gansel, MD, Principal investigator, Hospices Cicils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812537
- Sponsor's protocol ID
- 69HCL16_0136
- Acronym
- TRAJECTORIES
- Status last verified
- May 2023
- First submitted
- 13 Jun 2016
- Last updated
- 31 May 2023
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Social Trajectories of Children and Adolescents With Disruptive Behavior: Multidisciplinary Approach of Pediatric and Psychiatric Emergencies in the Rhône-Alpes Auvergne Region
- ClinicalTrials.gov ID
- NCT02812537
- Acronym / sponsor ID
- TRAJECTORIES / 69HCL16_0136
- Conditions
- Disruptive Behavior Disorder
- Keywords
- Trajectories, emergency room, conduct disorder, care management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Jun 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with conduct disorders | – | Other: patients with conduct disordersGirls and boys having less than 16 years old and admitted to emergency room for aggressiveness, violence, fugue or theft. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents admitted to emergency rooms for conduct disorder (aggressiveness, violence, fugue or theft)
Key inclusion criteria (2 listed)
- Children and adolescents less than 16 years old
- 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 |
|---|---|---|
| patients with conduct disordersinterview with a specialist | Other | patients with conduct disorders |
Primary outcome
Number of new admissions to emergency rooms for aggressiveness, violence, fugue or theft
Time frame: 6 months
Six months follow-up of these children and adolescents in their future trajectory after the first admission to emergency room for disruptive behavior
11 secondary outcomes
Age of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
Time frame: Day 0
Gender of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft
Time frame: Day 0
Number of children and adolescents precisely diagnosed with " behavior/conduct disorder
Time frame: Day 0
Number of hospitalization
Time frame: Day 0
number of patients admitted to emergency rooms for aggressiveness
Time frame: Day 0
number of patients admitted to emergency rooms for violence
Time frame: Day 0
number of patients admitted to emergency rooms for fugue
Time frame: Day 0
number of patients admitted to emergency rooms for theft
Time frame: Day 0
number of suicide attempts
Time frame: 24 months
number of patients with disruptive behavior recurrence
Time frame: 24 months
evolution of the CBCL score
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- 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.
Yannis Gansel, MD principal investigator
Hospices Cicils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disruptive Behavior Disorder, 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 2 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: looking for participants now, as of the sponsor's last update on 31 May 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannis Gansel, MD (472129562 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?
Number of new admissions to emergency rooms for aggressiveness, violence, fugue or theft (time frame: 6 months). 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 31 May 2023.