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Trial record 8 of 87 for:    Developmental Disabilities | ( Map: Canada )

Using Mobile Technology to Reduce Stereotypy

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ClinicalTrials.gov Identifier: NCT02124720
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Marc Lanovaz, Université de Montréal

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE April 28, 2014
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02124720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Mobile Technology to Reduce Stereotypy
Official Title  ICMJE Using Mobile Technology to Reduce Stereotypy in Children With Autism Spectrum Disorders
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Child Development Disorders, Pervasive
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Mobile application
Use of the iSTIM mobile application 2 to 4 times per week over approximately 8 to 16 weeks
Intervention: Behavioral: iSTIM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
39
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2014)
30
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02124720
Other Study ID Numbers  ICMJE CERFAS-2014-15-030-P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Lanovaz, Université de Montréal
Study Sponsor  ICMJE Université de Montréal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc J Lanovaz, Ph.D. Université de Montréal
PRS Account Université de Montréal
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP