Ecological Momentary Assessment with Smartphone© Application
OtherFilling of the application every 3 days for 6 months by subjects (parents of patients with ASD)
NCT Number: NCT03020277
This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to explore via a specific Smartphone© application the evolution of a child's behavior over 6 months and the (psychological and social) effects of these changes on the family.
Looking for future studies?
Notify Me3 year–16 year
All sexes
Interventional
Not applicable
Angers CHU, Angers, France
This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to assess the feasibility of using a Smartphone© application designed for parents of patients with ASD and to longitudinally collect data on the quality of life and anxiety of parents of children with ASD and the children's functional symptoms over multiple weeks under natural conditions.
Population:
The investigators propose to study individuals diagnosed with ASD based on National Health Authority (HAS) recommendations (on ADI-R diagnoses) from 3-16 years of age in the Pays de la Loire region. The investigators propose to include 100 families. The study is exploratory in nature; thus, randomizing patients is unnecessary. The investigators will include the first 100 families agreeing to participate in the study and meeting the inclusion criteria. All participants will be recruited from the Department of Child and Adolescent Psychiatry of University Hospital of Nantes and from the Regional Center for Autism (CRA des Pays de la Loire).
Method:
At the inclusion visit, parents will receive a code to download the app from the "application store" of their choice (depending on their Smartphone©) and sign an informed consent form.
All type 1 data from the inclusion visit will be stored in an electronic database and in the Smartphone© application (during the setup process).
This initial evaluation by the investigator will include the following type 1 data:
Type 2 data will be stored in the electronic database only:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)
Time frame: 6 months
The primary outcome measure will be the filling rate (R) and the use of our application by the parents over six months. This number will be Automatically Generated by Application (AGA)
Number of fillings = R 60
Time frame: every 3 days for 6 months
Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables
Time frame: every 3 days for 6 months
Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables
Time frame: every 3 days for 6 months
Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables
Time frame: every 3 days for 6 months
Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a Visual Analogic scale (VAS) from 0 (no) to 10 (severe) to measure the following variables
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is bad to 10 is perfect ) quotation about parental self esteem by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental anxiety by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental sleep by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental mood by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental stress by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental pain by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental professional life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental personal life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental social life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental support and resources from third persons by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
Time frame: every 3 days for 6 months
Time frame: every 3 days for 6 months
Time frame: every 3 days for 6 months
Nantes University Hospital
Other
Acronym: SMARTAUTISM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01031407
Adult, Asperger Syndrome
Bethesda, Maryland, United States
View Trial DetailsNCT02628808
Autism Spectrum Disorder, Autism Spectrum Disorders
Bordeaux, France
View Trial DetailsNCT02747459
Autism Spectrum Disorder, Autism Spectrum Disorders
Kansas City, Kansas, United States
View Trial DetailsNCT04442061
Autism Spectrum Disorder, Autism Spectrum Disorders
Paris, France
View Trial Details