Autism Spectrum Disorders
Conditions
Brief summary
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.
Detailed description
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: * Sibling rank and marital status, * Lifestyle: rural or urban; single or multiple occupants of the chid's bedroom and housing type and surface, * Educational and teaching load and conditions (special education, inclusive education, partial or full time, etc.), and * The therapeutic management (speech therapy, psychomotor therapy, etc.). Type 2 data will be stored in the electronic database only: * Age at diagnosis, * Current drug treatments (name, starting date and dose), * Comorbidities (associated epilepsy, mental retardation and organic pathology), * Medical and psychiatric family antecedent (ATCD), * Original scores on the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) at the time of diagnosis, and * Scores on the French version of the Childhood Autism Rating Scale (CARS) (http://www.autisme.qc.ca) at baseline and at the end of the study.
Interventions
OTHEREcological Momentary Assessment with Smartphone© Application
Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)
Sponsors
Institut de Recherche en Santé Publique, France
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Having a child with an ASD diagnosis based on the International Classification of Diseases (ICD) 10 criteria. * Having at least one Smartphone© (iOS Apple or Android). * Signing the consent form for participation.
Exclusion criteria
* Having several children with an ASD diagnosis. * Having children living in more than two areas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filling rate of the application | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| child sleep disorders | 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 |
| child eating disorders | 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 |
| child general behavior | 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 |
| Visual Analogic scale quotation about parental self esteem | 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) |
| Visual Analogic scale quotation about parental anxiety | 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) |
| Visual Analogic scale quotation about parental sleep | 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) |
| Visual Analogic scale quotation about parental mood | 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) |
| Visual Analogic scale quotation about parental stress | 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) |
| child behavior with pairs | 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 |
| Visual Analogic scale quotation about parental professional life | 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) |
| Visual Analogic scale quotation about parental personal life | 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) |
| Visual Analogic scale quotation about parental social life | 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) |
| Visual Analogic scale quotation about parental support and resources | 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) |
| the duration of use | every 3 days for 6 months | — |
| the time of use | every 3 days for 6 months | — |
| rate of complete filling | every 3 days for 6 months | — |
| Visual Analogic scale quotation about parental pain | 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) |
Countries
France
Outcome results
None listed