Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)
SMARTAUTISM
1 other identifier
interventional
65
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedStudy Start
First participant enrolled
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2019
CompletedMarch 20, 2024
January 1, 2024
1.2 years
December 19, 2016
March 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
child behavior with pairs
every 3 days for 6 months
child sleep disorders
every 3 days for 6 months
child eating disorders
every 3 days for 6 months
child general behavior
every 3 days for 6 months
Visual Analogic scale quotation about parental self esteem
every 3 days for 6 months
- +12 more secondary outcomes
Study Arms (1)
ASD children families
OTHERInterventions
Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Having several children with an ASD diagnosis.
- Having children living in more than two areas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Angers CHU
Angers, 49933, France
Nantes CHU
Nantes, 44093, France
Related Publications (1)
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.
PMID: 27881525BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Bonnot, PU-PH
Nantes CHU
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2016
First Posted
January 13, 2017
Study Start
April 3, 2018
Primary Completion
June 3, 2019
Study Completion
June 3, 2019
Last Updated
March 20, 2024
Record last verified: 2024-01