Using Mobile Technology to Reduce Stereotypy

Sponsor

Université de Montréal (Other)

Overall Status

Completed

CT.gov ID

NCT02124720

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Child Development Disorders, Pervasive	Behavioral: iSTIM	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

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 :

Dec 1, 2014

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Frequency and duration of stereotypy [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Years

Sexes Eligible for Study:

All

Accepts 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)