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Using Mobile Technology to Reduce Stereotypy

Primary Purpose

Child Development Disorders, Pervasive

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iSTIM
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Development Disorders, Pervasive focused on measuring Autism spectrum disorders, Stereotypy, Repetitive behavior

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Monarch House
  • CRDITED de Montréal
  • Gold Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile application

Arm Description

Use of the iSTIM mobile application 2 to 4 times per week over approximately 8 to 16 weeks

Outcomes

Primary Outcome Measures

Frequency and duration of stereotypy
Direct observation of the frequency and duration of stereotypy during 10- to 60-minute sessions

Secondary Outcome Measures

Social validity score
The user responds to a social validity questionnaire

Full Information

First Posted
April 24, 2014
Last Updated
September 24, 2019
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02124720
Brief Title
Using Mobile Technology to Reduce Stereotypy
Official Title
Using Mobile Technology to Reduce Stereotypy in Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorders, Pervasive
Keywords
Autism spectrum disorders, Stereotypy, Repetitive behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application
Arm Type
Experimental
Arm Description
Use of the iSTIM mobile application 2 to 4 times per week over approximately 8 to 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
iSTIM
Intervention Description
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 Measure Information:
Title
Frequency and duration of stereotypy
Description
Direct observation of the frequency and duration of stereotypy during 10- to 60-minute sessions
Time Frame
2 to 4 times per week over 8 to 16 weeks
Secondary Outcome Measure Information:
Title
Social validity score
Description
The user responds to a social validity questionnaire
Time Frame
Immediately following the end of the intervention (i.e., after 8 to 16 weeks)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Lanovaz, Ph.D.
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monarch House
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 5Y6
Country
Canada
Facility Name
CRDITED de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H8R 2H1
Country
Canada
Facility Name
Gold Centre
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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Using Mobile Technology to Reduce Stereotypy

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