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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01260792
Other study ID # 09-APN-02
Secondary ID
Status Completed
Phase N/A
First received December 14, 2010
Last updated March 23, 2012
Start date February 2010
Est. completion date December 2011

Study information

Verified date September 2009
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 2600
Est. completion date December 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
The teachers or the professors complete questionnaires on the child on their behavior in classes
Questionnaire
The parents complete a questionnaire on the behavior of their child and on their own behavior

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at time=0 No
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