- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03919721
Field Test of Motivity.Net Software for Data Collection During Behavioral Interventions
April 15, 2019 updated by: Experiad LLC
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rex Jakobovits, PhD
- Phone Number: 2065885811
- Email: clinicaltrials@motivity.net
Study Locations
-
-
Washington
-
Bellevue, Washington, United States, 98004
- Northwest Behavioral Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Child receiving applied behavior analysis at participating institution to treat autism disorder
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Learners receiving Applied Behavior Analysis therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
Likert scale to be administered at the end of study (8 weeks from start date)
|
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.
|
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
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
|
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)
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
|
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
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
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rex Rex, PhD, Experiad Solutions
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2019
Primary Completion (Anticipated)
March 31, 2020
Study Completion (Anticipated)
March 31, 2020
Study Registration Dates
First Submitted
March 19, 2019
First Submitted That Met QC Criteria
April 15, 2019
First Posted (Actual)
April 18, 2019
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Motivity-II
- R44MH098476 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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