AutismCCCCSysNCT01005953
Comprehensive Collection, Charting, and Communication System
An observational study of Autism, run by SymTrend Inc. at 1 site in United States.
Trial summary
As the prevalence of autism spectrum disorders continues to rise and the shortage of special education resources becomes more dramatic, the need for electronic tools that reduce the time burden of implementing an individual education plan (IEP) with pencil and paper methods becomes more apparent. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 2011
- Phase
- Observational
- 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 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Qualitative Family Research: This research is open to families with children 3-10 with autism who have broadband Internet access at home or at work, whose children receive services from more than one caregiver (OT, special educator, speech pathologist, behavioral analyst/therapist). Qualitative Professional Research: This research is open to professionals working with children 3-10 with autism who have broadband Internet access and who keep detailed records about the work they do with their clients. Quantitative Research: Only open to families and professionals who are part of two school districts: Cambridge, MA and Newton, MA, who also meet the above criteria.
Who may be able to join
None listed.
Who cannot join
- Have limited caseload in the two schools
- Work with children whose other professional colleagues working with those children are unwilling to participate (need at least two professionals/child)
- Families - Qualitative Inclusion Criteria
- Have child 3-10 who has lower functioning autism (with appropriate documentation), who is seen by more than one professional.
- Has broadband Internet access
- Families - Quantitative Inclusion Criteria
- Above criteria, plus has a child in one of the two programs participating in the study in Cambridge, MA and Newton, MA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of a Digital/Internet/Mobile System for Collecting, Charting and Communicating About the Behaviors of Children on the Autism Spectrum
As the prevalence of autism spectrum disorders continues to rise and the shortage of special education resources becomes more dramatic, the need for electronic tools that reduce the time burden of implementing an individual education plan (IEP) with pencil and paper methods becomes more apparent. SymTrend is going to expand its Internet and mobile computer/phone-based system for 1) collecting behavior data, 2) charting progress, 3) creating forms for #1 and #2, and 4) communicating within the IEP team, to include digital pen technology. Although this system will be tested with monitoring lower functioning children with autism, it has immediate relevance to a wide range of special education, mental health, and medical applications. The hypothesis is that this digital pen-based system will save time and money in the education of children on the spectrum and will enhance communication between schools and families.
Read the detailed description
Project Summary: SymTrend is seeking funding to bring low-cost, technology-afforded power and efficiency to the special education (SPED) of a lower functioning child with autism (LFCA). Each LFCA has a federally mandated, individualized education plan (IEP). An effective IEP requires intensive school and home-based behavioral monitoring: iterations of behavioral data recording, progress charting, and team communication. SymTrend will extend the functionality of its current Internet and mobile system for behavioral monitoring to include the use of digital pen technology for recording on specially printed forms. The project will then test the two types of electronic monitoring (iPod Touch and digital pens) against current pencil and paper monitoring. It is hypothesized that an electronic system with four components - i.e., forms creation, data collection, progress charting, and team communication - will reduce the time burden of behavioral monitoring and enable schools to meet the IEP needs of its students within the constraints of very restrictive educational budgets.
Objectives: The three objectives of this project are 1) to design and implement a four-component behavioral monitor for IEPs that is easy-to-use, cost-sensitive, and has the power and efficiency to optimize and sustain behavioral improvement in LFCA; 2) to incorporate functionality for an extensive range of a) learning contexts, b) types of behavioral measurement, and c) progress charting formats that meet IEP reporting requirements; and 3) to contrast electronic behavioral monitoring with standard paper methods in terms of: a) efficiency, b) power, and c) acceptance.
Design and Methods: The test of the system will include a sample 15 children participating in one of two public school systems. LFCA will be monitored by parents and more than one type of professional both at school and at home. Monitoring will occur in the context of skill learning and disruptive behavior elimination. Professionals will keep track of their time and effort doing behavioral recording, charting, and communicating with other members of the IEP team. The research design includes within-subject comparisons of baseline paper monitoring versus electronic monitoring in terms of efficiency, power, and acceptance.
Significance: The electronic behavioral monitoring system created to support IEP use with LFCA can also be used with higher functioning children with autism (HFCA), other developmental disabilities (e.
g., ADHD), other clinical uses (e.g., depression and anxiety), academic use (e.g., university level behavioral science) and commercial use (e.g., human factors studies).
- Conditions
- Autism
- Keywords
- Autism, Behavioral Observations, Electronic diaries, Professionals treating children 3-10 with lower functioning 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.
| Study group | Role | What they receive |
|---|---|---|
| Professionals treating autistic children | Special educators, occupational therapists, speech pathologists, behavior analysts who work with children on the spectrum. | |
| Families with autistic children (3-10) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SymTrend Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005953
- Sponsor's protocol ID
- 1R41MH086153-01
- Acronym
- CCCCSys
- Status last verified
- Jun 2011
- First submitted
- 30 Oct 2009
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of a Digital/Internet/Mobile System for Collecting, Charting and Communicating About the Behaviors of Children on the Autism Spectrum
- ClinicalTrials.gov ID
- NCT01005953
- Acronym / sponsor ID
- CCCCSys / 1R41MH086153-01
- Conditions
- Autism
- Keywords
- Autism, Behavioral Observations, Electronic diaries, Professionals treating children 3-10 with lower functioning autism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- SymTrend Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, National Institute of Mental Health (NIMH)
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 2 Nov 2009 (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.
As the prevalence of autism spectrum disorders continues to rise and the shortage of special education resources becomes more dramatic, the need for electronic tools that reduce the time burden of implementing an individual education plan (IEP) with pencil and paper methods becomes more apparent. SymTrend is going to expand its Internet and mobile computer/phone-based system for 1) collecting behavior data, 2) charting progress, 3) creating forms for #1 and #2, and 4) communicating within the IEP team, to include digital pen technology. Although this system will be tested with monitoring lower functioning children with autism, it has immediate relevance to a wide range of special education, mental health, and medical applications. The hypothesis is that this digital pen-based system will save time and money in the education of children on the spectrum and will enhance communication between schools and families.
Detailed description
Project Summary: SymTrend is seeking funding to bring low-cost, technology-afforded power and efficiency to the special education (SPED) of a lower functioning child with autism (LFCA). Each LFCA has a federally mandated, individualized education plan (IEP). An effective IEP requires intensive school and home-based behavioral monitoring: iterations of behavioral data recording, progress charting, and team communication. SymTrend will extend the functionality of its current Internet and mobile system for behavioral monitoring to include the use of digital pen technology for recording on specially printed forms. The project will then test the two types of electronic monitoring (iPod Touch and digital pens) against current pencil and paper monitoring. It is hypothesized that an electronic system with four components - i.e., forms creation, data collection, progress charting, and team communication - will reduce the time burden of behavioral monitoring and enable schools to meet the IEP needs of its students within the constraints of very restrictive educational budgets.
Objectives: The three objectives of this project are 1) to design and implement a four-component behavioral monitor for IEPs that is easy-to-use, cost-sensitive, and has the power and efficiency to optimize and sustain behavioral improvement in LFCA; 2) to incorporate functionality for an extensive range of a) learning contexts, b) types of behavioral measurement, and c) progress charting formats that meet IEP reporting requirements; and 3) to contrast electronic behavioral monitoring with standard paper methods in terms of: a) efficiency, b) power, and c) acceptance.
Design and Methods: The test of the system will include a sample 15 children participating in one of two public school systems. LFCA will be monitored by parents and more than one type of professional both at school and at home. Monitoring will occur in the context of skill learning and disruptive behavior elimination. Professionals will keep track of their time and effort doing behavioral recording, charting, and communicating with other members of the IEP team. The research design includes within-subject comparisons of baseline paper monitoring versus electronic monitoring in terms of efficiency, power, and acceptance.
Significance: The electronic behavioral monitoring system created to support IEP use with LFCA can also be used with higher functioning children with autism (HFCA), other developmental disabilities (e.
g., ADHD), other clinical uses (e.g., depression and anxiety), academic use (e.g., university level behavioral science) and commercial use (e.g., human factors studies).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professionals treating autistic children | – | –Special educators, occupational therapists, speech pathologists, behavior analysts who work with children on the spectrum. |
| Families with autistic children (3-10) | – | – |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Qualitative Family Research: This research is open to families with children 3-10 with autism who have broadband Internet access at home or at work, whose children receive services from more than one caregiver (OT, special educator, speech pathologist, behavioral analyst/therapist). Qualitative Professional Research: This research is open to professionals working with children 3-10 with autism who have broadband Internet access and who keep detailed records about the work they do with their clients. Quantitative Research: Only open to families and professionals who are part of two school districts: Cambridge, MA and Newton, MA, who also meet the above criteria.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Have limited caseload in the two schools
- Work with children whose other professional colleagues working with those children are unwilling to participate (need at least two professionals/child)
- Families - Qualitative Inclusion Criteria
- Have child 3-10 who has lower functioning autism (with appropriate documentation), who is seen by more than one professional.
- Has broadband Internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by SymTrend Inc. at 1 site in United States.
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 0 inclusion and 7 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 7 Jun 2011. 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 United States. 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.
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 7 Jun 2011.