Autistic DisorderNCT03919721
Field Test of Motivity.Net Software for Data Collection During Behavioral Interventions
A study testing Applied Behavioral Analysis in people with Autistic Disorder, run by Experiad LLC at 1 site in United States.
Trial summary
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection… Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Applied Behavioral Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Mar 2020
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child receiving applied behavior analysis at participating institution to treat autism disorder
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Behavioral Associates
Bellevue, Washington, 98004
About this study
Official title: Phase II Field Test of Motivity.Net - Therapy Management System for Model-Based Behavioral Interventions
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism.
Read the detailed description
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism. Experiad will conduct an 8-week within-subject pilot study of 6 BCBAs, 12 BTs and 12 children to answer product research questions about Motivity's ability to perform its intended functions, measuring the degree to which it allows interventionists to encode their models, achieve more efficient program management, improve communication, and increase responsiveness to a child's progress. Experiad will also use descriptive statistics to provide preliminary insight into the potential impact of the system on a child's performance in their ABA therapy.
- Conditions
- Autistic Disorder
- Being tested
- Applied Behavioral Analysis
- Keywords
- applied behavioral analysis, data collection software
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Behavioral AnalysisBehavioural
Children are receiving Applied Behavioral Analysis therapy to treat their autism. Therapy is comprised of 15-20 discrete programs that are intended to shape specific behaviors. Tutors collect data on child's performance towards goals. For each child, some of the programs will be tracked with paper data collection methods, others will use electronic data collection. This study is to test the usefulness of the electronic data collection system to replace paper in existing interventions.
| Study group | Role | What they receive |
|---|---|---|
| Learners receiving Applied Behavior Analysis therapy | Experimental | All children enrolled in the study will already receiving therapy. Each BT-child pair will have worked together regularly for at least 3 months prior to the study. Receives: Behavioral: Applied Behavioral Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of software on number of updates to programs made by behavior analysts (intervention agility)
Comparing the frequency of program updates between electronic programs and paper programs
Measured: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Event tracking usability assessed by user ratings
Number of tutors who rate it highly on likert scale
Measured: Likert scale to be administered at the end of study (8 weeks from start date)
Program editing efficiency as assessed by usage analysis
Comparison of total time spent editing electronic programs vs paper programs.
Measured: Time will be tracked continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Impact of software on trial success rate
Comparison of overall trial success rate (percent of trails meeting success threshold) in electronic administered programs compared to paper administered programs
Measured: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Impact of software on trials to criterion (number of trials needed to achieve mastery)
Comparison of trials to criterion (number of trials needed to achieve mastery) in electronic administered programs compared to paper administered programs
Measured: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Impact of software on total number of targets mastered
Comparison of total number of targets mastered in electronic administered programs compared to paper administered programs
Measured: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All children enrolled in the study will already receiving ABA therapy Each tutor-child pair will have worked together regularly for at least 3 months prior to the study. Each child will have 15-20 active therapy programs, each of which will be randomly assigned to one of two sets: the experimental (Motivity-enabled) or control (therapy-as-usual). For the control set, BTs will use their existing methods, either paper-based or a competitor's data collection system. Tutors will use Motivity for 8 weeks in therapy under supervision in a single case-study pilot.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Experiad LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington, northwest behavioral associates
- Responsible party
- Sponsor
- Investigators
- Rex Rex, PhD, Principal investigator, Experiad Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919721
- Sponsor's protocol ID
- Motivity-II
- Other IDs
- R44MH098476
- Status last verified
- Apr 2019
- First submitted
- 19 Mar 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Field Test of Motivity.Net - Therapy Management System for Model-Based Behavioral Interventions
- ClinicalTrials.gov ID
- NCT03919721
- Acronym / sponsor ID
- Motivity-II
- Conditions
- Autistic Disorder
- Keywords
- applied behavioral analysis, data collection software
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Experiad LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington, northwest behavioral associates
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 18 Apr 2019 (actual)
- 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.
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism.
Detailed description
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism. Experiad will conduct an 8-week within-subject pilot study of 6 BCBAs, 12 BTs and 12 children to answer product research questions about Motivity's ability to perform its intended functions, measuring the degree to which it allows interventionists to encode their models, achieve more efficient program management, improve communication, and increase responsiveness to a child's progress. Experiad will also use descriptive statistics to provide preliminary insight into the potential impact of the system on a child's performance in their ABA therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All children enrolled in the study will already receiving ABA therapy Each tutor-child pair will have worked together regularly for at least 3 months prior to the study. Each child will have 15-20 active therapy programs, each of which will be randomly assigned to one of two sets: the experimental (Motivity-enabled) or control (therapy-as-usual). For the control set, BTs will use their existing methods, either paper-based or a competitor's data collection system. Tutors will use Motivity for 8 weeks in therapy under supervision in a single case-study pilot.
| Arm | Type | Receives |
|---|---|---|
| Learners receiving Applied Behavior Analysis therapy | Experimental | Behavioral: Applied Behavioral AnalysisAll children enrolled in the study will already receiving therapy. Each BT-child pair will have worked together regularly for at least 3 months prior to the study. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Child receiving applied behavior analysis at participating institution to treat autism disorder
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Applied Behavioral AnalysisChildren are receiving Applied Behavioral Analysis therapy to treat their autism. Therapy is comprised of 15-20 discrete programs that are intended to shape specific behaviors. Tutors collect data on child's performance towards goals. For each child, some of the programs will be tracked with paper data collection methods, others will use electronic data collection. This study is to test the usefulness of the electronic data collection system to replace paper in existing interventions. | Behavioural | Learners receiving Applied Behavior Analysis therapy |
Primary outcome
Impact of software on number of updates to programs made by behavior analysts (intervention agility)
Time frame: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Comparing the frequency of program updates between electronic programs and paper programs
Event tracking usability assessed by user ratings
Time frame: Likert scale to be administered at the end of study (8 weeks from start date)
Number of tutors who rate it highly on likert scale
Program editing efficiency as assessed by usage analysis
Time frame: Time will be tracked continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Comparison of total time spent editing electronic programs vs paper programs.
Impact of software on trial success rate
Time frame: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Comparison of overall trial success rate (percent of trails meeting success threshold) in electronic administered programs compared to paper administered programs
Impact of software on trials to criterion (number of trials needed to achieve mastery)
Time frame: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Comparison of trials to criterion (number of trials needed to achieve mastery) in electronic administered programs compared to paper administered programs
Impact of software on total number of targets mastered
Time frame: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)
Comparison of total number of targets mastered in electronic administered programs compared to paper administered programs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Motivity online software for use by behavioral therapistsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Autistic Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
RecruitingObservational study
Sensory Profile of People With High Intellectual Potential (HIP)
High Intellectual Potential
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
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.
Rex Rex, PhD principal investigator
Experiad Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Behavioral Analysis in people with Autistic Disorder, run by Experiad LLC 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 1 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 18 Apr 2019. 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?
Contact Rex Jakobovits, PhD (2065885811, clinicaltrials@motivity.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of software on number of updates to programs made by behavior analysts (intervention agility) (time frame: Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)). The study lists 6 primary outcomes in all. 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 18 Apr 2019.