Effectiveness of a Therapeutic Education Program in Impro... | NCT05133284

Studies
Effectiveness of a Therapeutic Education Program in Improving Quality of Life of Children With ADHD and Their Parents

NCT05133284

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Nov 24, 2021Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Attention Deficit Disorder

Interventions

Not provided

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Mar 25, 2022Estimated

First Submitted Date

Oct 22, 2021

First Submission Date that Met QC Criteria

Nov 12, 2021

First Posted Date

Nov 24, 2021Actual

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

Nov 12, 2021

Last Update Posted Date

Nov 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by attention deficit, impulsivity and hyperactivity. It's one of the most frequently encoutered disorder in child psychiatry. ADHD has a significant impact on the quality of life of children and their parents.

In the child psychiatry department of the MPEA Peyre Plantade, a Therapeutic Education program specific to ADHD has been set up for children and their parents. This program consists of different workshops whose aim is to reduce the ADHD repercussions on the daily life of children and their families and thus improve their quality of life.

The principal aim of our study is to evaluate the effectiveness of this program in improving the quality of life of children with ADHD and their parents.

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

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

24Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life of children	To Evaluate the effectiveness of the therapeutic education program "Living better with ADHD" in improving quality of life of children with ADHD measured by the Kidscreen 27 questionnaire (Total score & sub score)	1 day

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Quality of life of parents	To evaluate the effectiveness of the program in improving the overall quality of life of parents measured by the WHOQOL-BREF questionnaire (Total score & sub score)	day 1
Clinical and sociodemiographic characteristics

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Aged 8 to 13
With a diagnosis of ADHD
Living in the herault department
Participatinf in the therapeutic education program " Living Well with ADHD "

Exclusion criteria:

Parent's objection to the use of data collected
Parent unable to complete questionnaires

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Children and adolescents, aged 8 to 13, with a diagnosis of ADHD and participating in the therapeutic education program " Living Well with ADHD "

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amaria BAGHDADLI, PU-PH	Contact	04 67 33 63 83	33	a-baghdadli@chu-montpellier.fr
Orane LE LIDEC, resident	Contact			o-lelidec@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Amaria BAGHDADLI, PU-PH	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided