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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Meurthe Et Moselle
    • Vandoeuvre les nancy, Meurthe Et Moselle, France, 54500
      • Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 (=day of inclusion = the only visit of the study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 0 (=day of inclusion = the only visit of the study)

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Investigators: Principal Investigator: Vanessa WOLFF, Centre Psychothérapique de Nancy

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: RIPH 2018-01; ID RCB 2018-A02303-52 (OTHER: ANSM (French competent authority))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No