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

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ClinicalTrials.gov Identifier: NCT03020277
Recruitment Status : Unknown
Verified January 2017 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
Institut de Recherche en Santé Publique, France
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Other: Ecological Momentary Assessment with Smartphone© Application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Filling rate of the application [ Time Frame: 6 months ]

    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



Secondary Outcome Measures :
  1. child behavior with pairs [ Time Frame: every 3 days for 6 months ]
    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

  2. child sleep disorders [ Time Frame: every 3 days for 6 months ]
    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

  3. child eating disorders [ Time Frame: every 3 days for 6 months ]
    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

  4. child general behavior [ Time Frame: every 3 days for 6 months ]
    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

  5. Visual Analogic scale quotation about parental self esteem [ Time Frame: every 3 days for 6 months ]
    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)

  6. Visual Analogic scale quotation about parental anxiety [ Time Frame: every 3 days for 6 months ]
    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)

  7. Visual Analogic scale quotation about parental sleep [ Time Frame: every 3 days for 6 months ]
    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)

  8. Visual Analogic scale quotation about parental mood [ Time Frame: every 3 days for 6 months ]
    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)

  9. Visual Analogic scale quotation about parental stress [ Time Frame: every 3 days for 6 months ]
    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)

  10. Visual Analogic scale quotation about parental pain [ Time Frame: every 3 days for 6 months ]
    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)

  11. Visual Analogic scale quotation about parental professional life [ Time Frame: every 3 days for 6 months ]
    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)

  12. Visual Analogic scale quotation about parental personal life [ Time Frame: every 3 days for 6 months ]
    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)

  13. Visual Analogic scale quotation about parental social life [ Time Frame: every 3 days for 6 months ]
    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)

  14. Visual Analogic scale quotation about parental support and resources [ Time Frame: every 3 days for 6 months ]
    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)

  15. the duration of use [ Time Frame: every 3 days for 6 months ]
  16. the time of use [ Time Frame: every 3 days for 6 months ]
  17. rate of complete filling [ Time Frame: every 3 days for 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020277


Contacts
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Contact: Olivier Bonnot, PU-PH 02 53 48 26 53 olivier.bonnot@chu-nantes.fr

Locations
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France
Nantes CHU Not yet recruiting
France, Nantes, France, 44093
Contact: Olivier Bonnot, PU-PH    02 53 48 26 53    olivier.bonnot@chu-nantes.fr   
Angers CHU Not yet recruiting
Angers, France, 49933
Contact: Philippe DUVERGER, PU-PH    02.41.35.36.37    PhDuverger@chu-angers.fr   
Sponsors and Collaborators
Nantes University Hospital
Institut de Recherche en Santé Publique, France
Investigators
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Principal Investigator: Olivier Bonnot, PU-PH Nantes CHU

Publications:
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03020277     History of Changes
Other Study ID Numbers: RC16_0185
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders