Attention Deficit Hyperactivity DisorderQuaVATNCT03719950
Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2019to 31 Dec 2019
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents (12 to 18 years old) with diagnosis of ADHD followed during regional child psychiatric consultation at Child department of Nancy University Hospital
Who may be able to join
- Adolescents aged 12 to 18 years
- Diagnosis of ADHD (f 90.0) ascertained by a child psychiatry according to CIM-10 criteria
- Seen by a child psychiatrist in consultation and accompanied by at least one of their parents
- Adolescents and at least one parent who has received enlightened information about the study
- Non-opposition to participate in the study gathered from at least one of their parents
- Patient affiliated or beneficiary of a social security scheme
Who cannot join
- Illiteracy of the parents or the adolescents
- Difficulties to understand french for the parents or the adolescents
Trial locations and contacts
1 site in 1 country.
France1 site
Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500
About this study
Official title: Monocentric Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Some of these studies were able to identify the fact that the higher the age of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge, only a few European studies have demonstrated the negative impact of ADHD on the quality of life of children and adolescents. In addition, these studies used only questionnaires intended for parents and not for children or adolescents.
During a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. A newsletter will be delivered to parents and one to the adolescent. If neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. He will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. At the end of this consultation, in the waiting room, adolescents will answer questionnaires KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These questionnaires will be handed to the secretary who will put them back in the patient's record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social information sheet will be source documents. The principal investigator or one of the associates investigators will complete the case report form from these source documents. For this purpose the data will be entered anonymously into a data entry software on a computer server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the software will be forwarded to Dr. Epstein of the Clinical Investigation Center for statistical analysis. The study will begin when the favourable opinion of the Ethical Research Comittees will be obtained and the study will last one year.
Read the detailed description
Cross-sectional, descriptive epidemiological study based on single-centre trials
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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.
The KIDSCREEN-27
A shorter version of KIDSCREEN-52 which is Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years The adolescent will consult his child psychiatrist and after he will answer to the questionnaire KIDSCREEN-27 during estimated time of fifteen minutes.
Measured: Day 0 (=day of inclusion = the only visit of the study)
Secondary outcomes (2)
The Child Behavior Check List (CBCL)
The Child Behavior Check List assess behavioral or emotional psychopathological traits of children and adolescents aged 4 to 18 years. It composed of 118 items. The adolescent will consult his child psychiatrist and the parents will complete the Child Behavior Check List during about twenty minutes
Measured: Day 0 (=day of inclusion = the only visit of the study)
The Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a self-administered questionnaire designed to measure perceived social support. Composed of 12 items, the MSPSS measures perceived social support from three sources: family, friends and significant others. The adolescent will consult his child psychiatrist and after he will answer the MSPSS during about five minutes
Measured: Day 0 (=day of inclusion = the only visit of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start2 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa WOLFF, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719950
- Sponsor's protocol ID
- RIPH 2018-01
- Other IDs
- ID RCB 2018-A02303-52
- Acronym
- QuaVAT
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2018
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03719950
- Acronym / sponsor ID
- QuaVAT / RIPH 2018-01
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Oct 2018 (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) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Some of these studies were able to identify the fact that the higher the age of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge, only a few European studies have demonstrated the negative impact of ADHD on the quality of life of children and adolescents. In addition, these studies used only questionnaires intended for parents and not for children or adolescents.
During a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. A newsletter will be delivered to parents and one to the adolescent. If neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. He will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. At the end of this consultation, in the waiting room, adolescents will answer questionnaires KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These questionnaires will be handed to the secretary who will put them back in the patient's record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social information sheet will be source documents. The principal investigator or one of the associates investigators will complete the case report form from these source documents. For this purpose the data will be entered anonymously into a data entry software on a computer server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the software will be forwarded to Dr. Epstein of the Clinical Investigation Center for statistical analysis. The study will begin when the favourable opinion of the Ethical Research Comittees will be obtained and the study will last one year.
Detailed description
Cross-sectional, descriptive epidemiological study based on single-centre trials
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents (12 to 18 years old) with diagnosis of ADHD followed during regional child psychiatric consultation at Child department of Nancy University Hospital
Key inclusion criteria (6 listed)
- Adolescents aged 12 to 18 years
- Diagnosis of ADHD (f 90.0) ascertained by a child psychiatry according to CIM-10 criteria
- Seen by a child psychiatrist in consultation and accompanied by at least one of their parents
- Adolescents and at least one parent who has received enlightened information about the study
- Non-opposition to participate in the study gathered from at least one of their parents
Key exclusion criteria (2 listed)
- Illiteracy of the parents or the adolescents
- Difficulties to understand french for the parents or the adolescents
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
The KIDSCREEN-27
Time frame: Day 0 (=day of inclusion = the only visit of the study)
A shorter version of KIDSCREEN-52 which is Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years The adolescent will consult his child psychiatrist and after he will answer to the questionnaire KIDSCREEN-27 during estimated time of fifteen minutes.
2 secondary outcomes
The Child Behavior Check List (CBCL)
Time frame: Day 0 (=day of inclusion = the only visit of the study)
The Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Day 0 (=day of inclusion = the only visit of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Vanessa WOLFF principal investigator
Centre Psychothérapique de Nancy
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 Hyperactivity Disorder, run by Centre Psychothérapique de Nancy 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 6 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: finished, as of the sponsor's last update on 20 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The KIDSCREEN-27 (time frame: Day 0 (=day of inclusion = the only visit of the study)). 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 20 Dec 2021.