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Autism Spectrum DisordersSMARTAUTISMNCT03020277

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

A study testing Ecological Momentary Assessment with Smartphone© Application in people with Autism Spectrum Disorders, run by Nantes University Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
Autism Spectrum Disorders
What is being tested?
Ecological Momentary Assessment with Smartphone© Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesFrance
Study dates
3 Apr 2018to 3 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Having several children with an ASD diagnosis.
  • Having children living in more than two areas

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Angers CHU

    Angers, 49933

  • Nantes CHU

    Nantes, 44093

Other trials in France

About this study

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.

Read the 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.
Being tested
Ecological Momentary Assessment with Smartphone© Application
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ecological Momentary Assessment with Smartphone© ApplicationOther

    Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)

Study groups in NCT03020277
Study groupRoleWhat they receive
ASD children familiesOtherNot described
Receives: Other: Ecological Momentary Assessment with Smartphone© Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (17)

  1. 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

    Measured: every 3 days for 6 months

  2. 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

    Measured: every 3 days for 6 months

  3. 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

    Measured: every 3 days for 6 months

  4. 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

    Measured: every 3 days for 6 months

  5. 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)

    Measured: every 3 days for 6 months

  6. 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)

    Measured: every 3 days for 6 months

  7. 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)

    Measured: every 3 days for 6 months

  8. 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)

    Measured: every 3 days for 6 months

  9. 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)

    Measured: every 3 days for 6 months

  10. 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)

    Measured: every 3 days for 6 months

  11. 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)

    Measured: every 3 days for 6 months

  12. 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)

    Measured: every 3 days for 6 months

  13. 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)

    Measured: every 3 days for 6 months

  14. 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)

    Measured: every 3 days for 6 months

  15. the duration of use

    Measured: every 3 days for 6 months

  16. the time of use

    Measured: every 3 days for 6 months

  17. rate of complete filling

    Measured: every 3 days for 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study start3 Apr 2018
  3. Primary completion3 Jun 2019
  4. Study completion3 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03020277
Sponsor's protocol ID
RC16_0185
Acronym
SMARTAUTISM
Status last verified
Jan 2024
First submitted
19 Dec 2016
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 27881525

Questions about this trial

What is this clinical trial studying?

A study testing Ecological Momentary Assessment with Smartphone© Application in people with Autism Spectrum Disorders, run by Nantes University Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Filling rate of the application (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03020277, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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