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Trial record 8 of 84 for:    Developmental Disabilities | ( Map: Canada )

Using Mobile Technology to Reduce Stereotypy

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ClinicalTrials.gov Identifier: NCT02124720
Recruitment Status : Recruiting
First Posted : April 28, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Lanovaz, Université de Montréal

Brief Summary:
Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may considerably interfere with the child's daily functioning, learning, and social inclusion. As such, stereotypy generally has a negative impact on the child and family's health and quality of life. Several behavioural interventions have been developed to reduce engagement in stereotypy in children with autism spectrum disorders, but the limited number of specialists available, the long waiting lists associated with public health services in Canada, and the high costs of private services have considerably restricted accessibility. One potential solution to the limited availability and high costs of services is using a mobile application to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy. To this end, the purpose of the study is to evaluate the effects of the iSTIM (i.e., individualized Stereotypy Treatment Integrated Modules), a mobile application designed to assist parents in reducing stereotypy in children with autism spectrum disorders. Specifically, we will assess whether the iSTIM correctly estimates the frequency or duration of stereotypy, offers suggestions consistent with recommended clinical practices, effectively reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for parents of children with autism spectrum disorders. The results of the study will allow us to determine whether the mobile application may be used to treat this core symptom in children with autism spectrum disorders, which could potentially reduce waiting times and costs of providing health services to this population. By reducing engagement in stereotypy, the iSTIM may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.

Condition or disease Intervention/treatment Phase
Child Development Disorders, Pervasive Behavioral: iSTIM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Mobile Technology to Reduce Stereotypy in Children With Autism Spectrum Disorders
Study Start Date : December 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile application
Use of the iSTIM mobile application 2 to 4 times per week over approximately 8 to 16 weeks
Behavioral: iSTIM
Trained research assistants and parents will implement the assessments and interventions recommended by the iSTIM mobile application during sessions lasting between 10 and 60 minutes




Primary Outcome Measures :
  1. Frequency and duration of stereotypy [ Time Frame: 2 to 4 times per week over 8 to 16 weeks ]
    Direct observation of the frequency and duration of stereotypy during 10- to 60-minute sessions


Secondary Outcome Measures :
  1. Social validity score [ Time Frame: Immediately following the end of the intervention (i.e., after 8 to 16 weeks) ]
    The user responds to a social validity questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of autism spectrum disorders
  • Must engage in at least one form of stereotypy

Exclusion Criteria:

  • Stereotypy occurs less than 12 times per hour (or less than 20% of time)
  • The form of stereotypy is potentially dangerous for the person (e.g., head banging, self-biting)
  • The form of stereotypy is maintained by social consequences (e.g., attention, task avoidance)

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): NCT02124720


Locations
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Canada, Ontario
Monarch House Recruiting
Mississauga, Ontario, Canada, L5L 5Y6
Contact: Jennifer Cook    (905) 569-3199    jcook@monarchhouse.ca   
Canada, Quebec
CRDITED de Montréal Recruiting
Montreal, Quebec, Canada, H8R 2H1
Contact: Chantal Mongeau    514-364-2282 ext 2413    recherche@crditedmtl.ca   
Gold Centre Recruiting
Montreal, Quebec, Canada
Contact: Nathalie Garcin    514 345-8330    nathalieg@goldlearningcentre.com   
Sponsors and Collaborators
Université de Montréal
Investigators
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Principal Investigator: Marc J Lanovaz, Ph.D. Université de Montréal

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Responsible Party: Marc Lanovaz, Assistant Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT02124720     History of Changes
Other Study ID Numbers: CERFAS-2014-15-030-P
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Marc Lanovaz, Université de Montréal:
Autism spectrum disorders
Stereotypy
Repetitive behavior

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Stereotypic Movement Disorder
Neurodevelopmental Disorders
Mental Disorders