Children and Parents With ADHD and Related Disorders

General Population Clinical Trial

— ChiP-ARD  

Official title:

Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260792
• Other study ID #: 09-APN-02
• 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

• Attention Deficit Disorder with Hyperactivity
• Children Aged 5 to 18 Years
• General Population
• TDAH

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