Using Mobile Technology to Reduce Stereotypy

NCT02124720 | Completed

• 1 other identifier: CERFAS-2014-15-030-P
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Child Development Disorders, Pervasive

Keywords

Autism spectrum disorders; Stereotypy; Repetitive behavior

Outcome Measures

Primary Outcomes (1)

• Frequency and duration of stereotypy

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

  2 to 4 times per week over 8 to 16 weeks

Secondary Outcomes (1)

• Social validity score

  Immediately following the end of the intervention (i.e., after 8 to 16 weeks)

Study Arms (1)

Mobile application

EXPERIMENTAL

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

Behavioral: iSTIM

Interventions

iSTIM BEHAVIORAL

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

Mobile application

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (3)

Monarch House

Mississauga, Ontario, L5L 5Y6, Canada

Location

CRDITED de Montréal

Montreal, Quebec, H8R 2H1, Canada

Location

Gold Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Autism Spectrum Disorder; Stereotypic Movement Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Marc J Lanovaz, Ph.D.

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

CA (3)