General PopulationChiP-ARDNCT01260792
Children and Parents With ADHD and Related Disorders
An observational study of General Population and TDAH, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population, TDAH, Children Aged 5 to 18 Years
- What is being tested?
- questionnaire
- How many people
- 2,600 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Dec 2011
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Two non-independant study groups: children aged 5 to 18, and at least one of their parents
Who may be able to join
- Child known for the teacher for at least three months so that his evaluation Reflect most faithfully possible the usual behavior of the child,
- Child having the Frenchman for mother tongue to avoid the consequences on him Behavior of a linguistic obstacle,
- Authorization to use the data signed by at least one of the parents of the child and by the very child when he is old at least of six years.
- Parents speaking and reading the Frenchman.
Who cannot join
- Child known to follow a specific treatment of a disorder(confusion)attentional with / without Hyperactivity-impulsiveness (eg. Ritaline Ò, Ritaline Ò LP, Arranged Ò LP, Strattera Ò) Whatever is its duration. Indeed, a selection on this criterion would introduce a way Major which(who) would return the less reliable results(profits) of the study.
- Child presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\or psychiatric.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors.
Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. This study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of Nice.
Children are pseudo-randomly selected from classes of randomly selected schools in the city of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. Since ADHD has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.
Additionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study.
- Conditions
- General Population, TDAH, Children Aged 5 to 18 Years
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
The teachers or the professors complete questionnaires on the child on their behavior in classes
QuestionnaireOther
The parents complete a questionnaire on the behavior of their child and on their own behavior
| Study group | Role | What they receive |
|---|---|---|
| Children | Children between 5 and 18 years old. Receives: Other: questionnaire | |
| Adults | Parents of children between 5 and 18 years old Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of studied instruments
The only criterion of evaluation towards the type of the study and its main objective is Validity of the studied instruments
Measured: at time=0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for General PopulationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Time perspective
- Prospective
- Enrolment
- 2,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé CACI, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260792
- Sponsor's protocol ID
- 09-APN-02
- Acronym
- ChiP-ARD
- Status last verified
- Sep 2009
- First submitted
- 14 Dec 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Caci HM, Morin AJ, Tran A. Prevalence and correlates of attention deficit hyperactivity disorder in adults from a French community sample. J Nerv Ment Dis. 2014 Apr;202(4):324-32. doi: 10.1097/NMD.0000000000000126.
PubMed 24647218Morin AJ, Tran A, Caci H. Factorial Validity of the ADHD Adult Symptom Rating Scale in a French Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 Jun;20(6):530-41. doi: 10.1177/1087054713488825. Epub 2013 May 31.
PubMed 23729493Caci HM, Morin AJ, Tran A. Teacher Ratings of the ADHD-RS IV in a Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 May;20(5):434-44. doi: 10.1177/1087054712473834. Epub 2013 Feb 19.
PubMed 23422236
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors.
- ClinicalTrials.gov ID
- NCT01260792
- Acronym / sponsor ID
- ChiP-ARD / 09-APN-02
- Conditions
- General Population, TDAH, Children Aged 5 to 18 Years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Dec 2010 (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.
Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. This study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of Nice.
Children are pseudo-randomly selected from classes of randomly selected schools in the city of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. Since ADHD has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.
Additionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: questionnaireChildren between 5 and 18 years old. |
| Adults | – | Other: QuestionnaireParents of children between 5 and 18 years old |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Two non-independant study groups: children aged 5 to 18, and at least one of their parents
Key inclusion criteria (4 listed)
- Child known for the teacher for at least three months so that his evaluation Reflect most faithfully possible the usual behavior of the child,
- Child having the Frenchman for mother tongue to avoid the consequences on him Behavior of a linguistic obstacle,
- Authorization to use the data signed by at least one of the parents of the child and by the very child when he is old at least of six years.
- Parents speaking and reading the Frenchman.
Key exclusion criteria (2 listed)
- Child known to follow a specific treatment of a disorder(confusion)attentional with / without Hyperactivity-impulsiveness (eg. Ritaline Ò, Ritaline Ò LP, Arranged Ò LP, Strattera Ò) Whatever is its duration. Indeed, a selection on this criterion would introduce a way Major which(who) would return the less reliable results(profits) of the study.
- Child presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\or psychiatric.
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 |
|---|---|---|
| questionnaireThe teachers or the professors complete questionnaires on the child on their behavior in classes | Other | Children |
| QuestionnaireThe parents complete a questionnaire on the behavior of their child and on their own behavior | Other | Adults |
Primary outcome
Validity of studied instruments
Time frame: at time=0
The only criterion of evaluation towards the type of the study and its main objective is Validity of the studied instruments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 24647218Caci HM, Morin AJ, Tran A. Prevalence and correlates of attention deficit hyperactivity disorder in adults from a French community sample. J Nerv Ment Dis. 2014 Apr;202(4):324-32. doi: 10.1097/NMD.0000000000000126.
- Derived from this study: PubMed 23729493Morin AJ, Tran A, Caci H. Factorial Validity of the ADHD Adult Symptom Rating Scale in a French Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 Jun;20(6):530-41. doi: 10.1177/1087054713488825. Epub 2013 May 31.
- Derived from this study: PubMed 23422236Caci HM, Morin AJ, Tran A. Teacher Ratings of the ADHD-RS IV in a Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 May;20(5):434-44. doi: 10.1177/1087054712473834. Epub 2013 Feb 19.
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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.
Hervé CACI, PH principal investigator
Centre Hospitalier Universitaire de Nice
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 General Population and TDAH, run by Centre Hospitalier Universitaire de Nice 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 4 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: finished, as of the sponsor's last update on 26 Mar 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of studied instruments (time frame: at time=0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260792, which also lists 3 linked publications.
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 26 Mar 2012.