Children and Parents With ADHD and Related Disorders | NCT01260792

Studies
Children and Parents With ADHD and Related Disorders

NCT01260792

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Mar 26, 2012Estimated

Enrollment

2,600Actual

Phase

Not provided

Conditions

General Population
TDAH
Children Aged 5 to 18 Years

Interventions

questionnaire
Questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 14, 2010

First Posted Date

Dec 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children		Children between 5 and 18 years old.	Other: questionnaire
Adults		Parents of children between 5 and 18 years old	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	The teachers or the professors complete questionnaires on the child on their behavior in classes	Children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Two non-independant study groups: children aged 5 to 18, and at least one of their parents

Sampling Method

Probability Sample

Name	Affiliation	Role
Hervé CACI, PH	Centre Hospitalier Universitaire de Nice	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		Nice		06000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24647218	Derived	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.
23729493	Derived	Morin 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.

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms