Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder

NCT ID: NCT03719950

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cross-sectional, descriptive epidemiological study based on single-centre trials

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Illiteracy of the parents or the adolescents
* Difficulties to understand french for the parents or the adolescents
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Psychothérapique de Nancy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vanessa WOLFF

Role: PRINCIPAL_INVESTIGATOR

Centre Psychothérapique de Nancy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID RCB 2018-A02303-52

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH 2018-01

Identifier Type: -

Identifier Source: org_study_id