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

Attention Deficit Hyperactivity Disorder Clinical Trial

— QuaVAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719950
• Other study ID #: RIPH 2018-01
• Secondary ID: ID RCB 2018-A023
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Centre Psychothérapique de Nancy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Locations

Country	Name	City	State
France	Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy	Vandoeuvre les nancy	Meurthe Et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Psychothérapique de Nancy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)