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

Sponsor
Centre Psychothérapique de Nancy (Other)
Overall Status
Completed
CT.gov ID
NCT03719950
Collaborator
(none)
40
1
11.9
3.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Monocentric Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder
    Actual Study Start Date :
    Jan 2, 2019
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. The KIDSCREEN-27 [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.

    Secondary Outcome Measures

    1. The Child Behavior Check List (CBCL) [Day 0 (=day of inclusion = the only visit of the study)]

      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

    2. The Multidimensional Scale of Perceived Social Support (MSPSS) [Day 0 (=day of inclusion = the only visit of the study)]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy Vandoeuvre les nancy Meurthe Et Moselle France 54500

    Sponsors and Collaborators

    • Centre Psychothérapique de Nancy

    Investigators

    • Principal Investigator: Vanessa WOLFF, Centre Psychothérapique de Nancy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Psychothérapique de Nancy
    ClinicalTrials.gov Identifier:
    NCT03719950
    Other Study ID Numbers:
    • RIPH 2018-01
    • ID RCB 2018-A02303-52
    First Posted:
    Oct 25, 2018
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 20, 2021