Child Development Disorders, PervasiveNCT02124720
Using Mobile Technology to Reduce Stereotypy
A study testing iSTIM in people with Child Development Disorders, Pervasive, run by Université de Montréal at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Child Development Disorders, Pervasive
- What is being tested?
- iSTIM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of autism spectrum disorders
- Must engage in at least one form of stereotypy
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Monarch House
Mississauga, Ontario, L5L 5Y6
CRDITED de Montréal
Montreal, Quebec, H8R 2H1
Gold Centre
Montreal, Quebec
About this study
Official title: Using Mobile Technology to Reduce Stereotypy in Children With Autism Spectrum Disorders
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
- Being tested
- iSTIM
- Keywords
- Autism spectrum disorders, Stereotypy, Repetitive behavior
- Medical subject headings
- Child Development Disorders, Pervasive, Autism Spectrum Disorder, Stereotypic Movement Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSTIMBehavioural
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 group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | Use of the iSTIM mobile application 2 to 4 times per week over approximately 8 to 16 weeks Receives: Behavioral: iSTIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and duration of stereotypy
Direct observation of the frequency and duration of stereotypy during 10- to 60-minute sessions
Measured: 2 to 4 times per week over 8 to 16 weeks
Secondary outcomes (1)
Social validity score
The user responds to a social validity questionnaire
Measured: Immediately following the end of the intervention (i.e., after 8 to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development Disorders, PervasiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Lanovaz, Université de Montréal
- Investigators
- Marc J Lanovaz, Ph.D., Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124720
- Sponsor's protocol ID
- CERFAS-2014-15-030-P
- Status last verified
- Sep 2019
- First submitted
- 24 Apr 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mobile Technology to Reduce Stereotypy in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02124720
- Acronym / sponsor ID
- CERFAS-2014-15-030-P
- Conditions
- Child Development Disorders, Pervasive
- Keywords
- Autism spectrum disorders, Stereotypy, Repetitive behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Behavioral: iSTIMUse of the iSTIM mobile application 2 to 4 times per week over approximately 8 to 16 weeks |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of autism spectrum disorders
- Must engage in at least one form of stereotypy
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSTIMTrained research assistants and parents will implement the assessments and interventions recommended by the iSTIM mobile application during sessions lasting between 10 and 60 minutes | Behavioural | Mobile application |
Primary outcome
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
1 secondary outcome
Social validity score
Time frame: Immediately following the end of the intervention (i.e., after 8 to 16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc J Lanovaz, Ph.D. principal investigator
Université de Montréal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSTIM in people with Child Development Disorders, Pervasive, run by Université de Montréal at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and duration of stereotypy (time frame: 2 to 4 times per week over 8 to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.