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Field Test of Motivity.Net Software for Data Collection During Behavioral Interventions

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ClinicalTrials.gov Identifier: NCT03919721
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Washington
northwest behavioral associates
Information provided by (Responsible Party):
Experiad LLC

Brief 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 and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism.

Condition or disease Intervention/treatment Phase
Autistic Disorder Behavioral: Applied Behavioral Analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Phase II Field Test of Motivity.Net - Therapy Management System for Model-Based Behavioral Interventions
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

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.
Behavioral: Applied Behavioral Analysis
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child receiving applied behavior analysis at participating institution to treat autism disorder

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919721


Contacts
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Contact: Rex Jakobovits, PhD 2065885811 clinicaltrials@motivity.net

Locations
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United States, Washington
Northwest Behavioral Associates
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Experiad LLC
National Institute of Mental Health (NIMH)
University of Washington
northwest behavioral associates
Investigators
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Principal Investigator: Rex Rex, PhD Experiad Solutions

Additional Information:
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Responsible Party: Experiad LLC
ClinicalTrials.gov Identifier: NCT03919721     History of Changes
Other Study ID Numbers: Motivity-II
R44MH098476 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Experiad LLC:
applied behavioral analysis
data collection software

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders