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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Other: Ecological Momentary Assessment with Smartphone© Application

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Angers CHU
  • Nantes, France, 44093
    • Nantes CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ASD children families	Other: Ecological Momentary Assessment with Smartphone© Application; Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filling rate of the application	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child behavior with pairs	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	every 3 days for 6 months
child sleep disorders	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	every 3 days for 6 months
child eating disorders	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	every 3 days for 6 months
child general behavior	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	every 3 days for 6 months
Visual Analogic scale quotation about parental self esteem	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental anxiety	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental sleep	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental mood	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental stress	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental pain	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental professional life	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental personal life	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental social life	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)	every 3 days for 6 months
Visual Analogic scale quotation about parental support and resources	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)	every 3 days for 6 months
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Institut de Recherche en Santé Publique, France
• Investigators: Principal Investigator: Olivier Bonnot, PU-PH, Nantes CHU

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): June 3, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: RC16_0185

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No