NCT03020277

Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorders

Interventions

Type	Name	Description
OTHER	Ecological Momentary Assessment with Smartphone© Application	Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)

Timeline

• Start date: 2018-04-03
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2017-01-13
• Last updated: 2024-03-20

Locations

2 sites across 1 country: France