Clinical trial NCT03020277: Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)
Official title: Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé Publique, France
First posted: 2017-01-13
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Filling rate of the application
timeFrame: 6 months
Secondary outcomes:
measure: child behavior with pairs
timeFrame: every 3 days for 6 months
measure: child sleep disorders
timeFrame: every 3 days for 6 months
measure: child eating disorders
timeFrame: every 3 days for 6 months
measure: child general behavior
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental self esteem
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental anxiety
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental sleep
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental mood
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental stress
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental pain
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental professional life
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental personal life
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental social life
timeFrame: every 3 days for 6 months
measure: Visual Analogic scale quotation about parental support and resources
timeFrame: every 3 days for 6 months
measure: the duration of use
timeFrame: every 3 days for 6 months
measure: the time of use
timeFrame: every 3 days for 6 months
measure: rate of complete filling
timeFrame: every 3 days for 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers CHU
city: Nantes
country: France
facility: Nantes CHU
Study officials:
affiliation: Nantes CHU
name: Olivier Bonnot, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnot O, Bonneau D, Doudard A, Duverger P. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM. BMJ Open. 2016 Nov 22;6(11):e012135. doi: 10.1136/bmjopen-2016-012135.