AutismNCT02591459
Android Mobile Devices to Assist Routine Anticipation for Autistic Children
A study testing Using the app to assist routine anticipation in people with Autism, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial summary
The objective of this work is to develop an application to run on a mobile device Android tablet that features visual routines for autistic children. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Autism
- What is being tested?
- Using the app to assist routine anticipation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Dec 2015
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a diagnosis of autism development by DSM-IV
- Have sufficient motor skills to perform operations on a tablet
- Be aware of PECS
- Children should be accustomed to the visual routines used in
Who cannot join
- Have visual impairment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de inclusão e Apoio ao Autista de Guarulhos (CIAAG)
Guarulhos, São Paulo
About this study
The objective of this work is to develop an application to run on a mobile device Android tablet that features visual routines for autistic children.
Read the detailed description
Autism is a disorder characterized by social deficits, and among others by changes in communication. The diagnosis of this disorder remains accomplished by direct assessment the individual's behavior, according to specific clinical criteria present the classification systems of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). Therapists teach autistic to communicate with the help of symbols and auxiliary anticipation and communication routines, usually using the Picture Exchange Communication System (PECS), or photos. However these are presented in transition PECS cards and do not follow the children in activities that develop outside the school environment. The objective of this work is to develop an application to run on a mobile device Android tablet that features the visual routines.
In this way the routines can be accessed outside the school environment. This technology is easy to use and facilitates data entry by touching the screen, was developed using the Unified Modeling Language (UML), Javascript, Apache Web server and Web browser Chrome. The application validation, will be held with 10 autistic and 2 teachers from the center of inclusion and support for autistic. Teachers should insert the activities programmed for each autistic student. Tablet in student performance in communicating with this tablet will be measured. Parents or guardians knowledge with the PECS system will be trained and will be evaluated on their autonomy inserting images, audio and subtitles. The application should aid communication, cause the autistic understand the sequence of events in daily life, decreasing their aggression because of not knowing what will be their next activity. Participation in this research poses no risk or harm the concerned person. If during the research participant decides not anymore have the freedom to do so without incurring any damage you. The technical validation proposal is necessary for it to be used by people with autism. If validated in a positive way, the technique could improve the quality of life of these people and their families.
- Conditions
- Autism
- Being tested
- Using the app to assist routine anticipation
- Keywords
- Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using the app to assist routine anticipationOther
Using the app to assist routine anticipation for autistic children in Android mobile devices
| Study group | Role | What they receive |
|---|---|---|
| Autism | Other | Using the app to assist routine anticipation for autistic children in Android mobile devices Receives: Other: Using the app to assist routine anticipation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in verbal communication
Increased verbal communication in autistic individuals (as a percentage)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annie France Frère Slaets, University of Mogi das Cruzes
- Investigators
- Annie F Frere Slaets, PhD, Principal investigator, University of Mogi Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591459
- Sponsor's protocol ID
- 49354415.0.0000.5497
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Android Mobile Devices to Assist Routine Anticipation for Autistic Children
- ClinicalTrials.gov ID
- NCT02591459
- Acronym / sponsor ID
- 49354415.0.0000.5497
- Conditions
- Autism
- Keywords
- Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Oct 2015 (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.
The objective of this work is to develop an application to run on a mobile device Android tablet that features visual routines for autistic children.
Detailed description
Autism is a disorder characterized by social deficits, and among others by changes in communication. The diagnosis of this disorder remains accomplished by direct assessment the individual's behavior, according to specific clinical criteria present the classification systems of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). Therapists teach autistic to communicate with the help of symbols and auxiliary anticipation and communication routines, usually using the Picture Exchange Communication System (PECS), or photos. However these are presented in transition PECS cards and do not follow the children in activities that develop outside the school environment. The objective of this work is to develop an application to run on a mobile device Android tablet that features the visual routines.
In this way the routines can be accessed outside the school environment. This technology is easy to use and facilitates data entry by touching the screen, was developed using the Unified Modeling Language (UML), Javascript, Apache Web server and Web browser Chrome. The application validation, will be held with 10 autistic and 2 teachers from the center of inclusion and support for autistic. Teachers should insert the activities programmed for each autistic student. Tablet in student performance in communicating with this tablet will be measured. Parents or guardians knowledge with the PECS system will be trained and will be evaluated on their autonomy inserting images, audio and subtitles. The application should aid communication, cause the autistic understand the sequence of events in daily life, decreasing their aggression because of not knowing what will be their next activity. Participation in this research poses no risk or harm the concerned person. If during the research participant decides not anymore have the freedom to do so without incurring any damage you. The technical validation proposal is necessary for it to be used by people with autism. If validated in a positive way, the technique could improve the quality of life of these people and their families.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autism | Other | Other: Using the app to assist routine anticipationUsing the app to assist routine anticipation for autistic children in Android mobile devices |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Have a diagnosis of autism development by DSM-IV
- Have sufficient motor skills to perform operations on a tablet
- Be aware of PECS
- Children should be accustomed to the visual routines used in
Key exclusion criteria (1 listed)
- Have visual impairment
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 |
|---|---|---|
| Using the app to assist routine anticipationUsing the app to assist routine anticipation for autistic children in Android mobile devices | Other | Autism |
Primary outcome
Increase in verbal communication
Time frame: 1 month
Increased verbal communication in autistic individuals (as a percentage)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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.
Annie F Frere Slaets, PhD principal investigator
University of Mogi Cruzes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using the app to assist routine anticipation in people with Autism, run by University of Mogi das Cruzes at 1 site in Brazil.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
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?
Increase in verbal communication (time frame: 1 month). 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 29 Oct 2015.