Attention Deficit DisorderNCT05133284
Effectiveness of a Therapeutic Education Program in Improving Quality of Life of Children With ADHD and Their Parents
An observational study of Attention Deficit Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Attention Deficit Disorder
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 25 Mar 2022
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- 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 "
Who may be able to join
- Aged 8 to 13
- With a diagnosis of ADHD
- Living in the herault department
- Participatinf in the therapeutic education program " Living Well with ADHD "
Who cannot join
- Parent's objection to the use of data collected
- Parent unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
Orane LE LIDEC, resident contact
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Orane LE LIDEC, resident, o-lelidec@chu-montpellier.fr
About this study
Official title: Evaluation of the Effectiveness of the Therapeutic Education Program "Living Better With ADHD" in Improving the Quality of Life of Children With ADHD and Their Parents
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.
- Conditions
- Attention Deficit Disorder
- Keywords
- Therapeutic Education, Quality of life
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion25 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaria BAGHDADLI, PU-PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133284
- Sponsor's protocol ID
- RECHMPL21_0634
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Therapeutic Education Program "Living Better With ADHD" in Improving the Quality of Life of Children With ADHD and Their Parents
- ClinicalTrials.gov ID
- NCT05133284
- Acronym / sponsor ID
- RECHMPL21_0634
- Conditions
- Attention Deficit Disorder
- Keywords
- Therapeutic Education, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 25 Mar 2022 (estimated)
- First posted
- 24 Nov 2021 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 "
Key inclusion criteria (4 listed)
- Aged 8 to 13
- With a diagnosis of ADHD
- Living in the herault department
- Participatinf in the therapeutic education program " Living Well with ADHD "
Key exclusion criteria (2 listed)
- Parent's objection to the use of data collected
- Parent unable to complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life of children
Time frame: 1 day
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Orane LE LIDEC, resident contact
Amaria BAGHDADLI, PU-PH study director
University Hospital, Montpellier
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 Attention Deficit Disorder, run by University Hospital, Montpellier 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amaria BAGHDADLI, PU-PH (04 67 33 63 83 ext. 33, a-baghdadli@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of children (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2021.