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Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500771
Recruitment Status : Not yet recruiting
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Collaborator:
northwest behavioral associates
Information provided by (Responsible Party):
Rex Jakobovits, Experiad LLC

Brief Summary:
This is a project to be funded by a Fast-Track Small Business Innovative Research to build and test the feasibility of a new software prototype called V-Motive which will facilitate the combination of two proven autism behavioral interventions: Applied Behavior Analysis therapy (ABA) and Video Modeling (VM). The investigators will conduct a Phase I feasibility analysis and Phase II pilot study of the V-Motive Prototype by observing a community therapy providers' use of the prototype in a therapy setting. Investigators will observe the users and record the success or failure of the performance of key functions of the software. Investigators will also administer surveys. The study will answer research questions about V-Motive's ability to perform its intended function: allowing interventionists to feasibly leverage video modeling within ABA therapy with a minimal amount of overhead and labor.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: ABA therapy enhanced with V-Motive software Not Applicable

Detailed Description:
Investigators will conduct a within-subject pilot study of 6 tutors and 6 children to answer research questions about V-Motive's ability to perform its intended function. The goal is to evaluate the feasibility, usability, and the potential of V-Motive to deliver comprehensive, individualized video modeling that is integrated with a child's program. Investigators 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. However, these data are NOT intended to show cause or to show effectiveness. The study will answer the following questions: 1) 3) Can V-Motive be feasibly used during ABA therapy to positively impact a child's performance within 4 weeks? 2) How laborious is it to construct a fully-indexed video repository from therapy footage using V-Motive? 3) How accurate is the system in suggesting and cueing up appropriate video for playback on demand?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
Study Start Date : June 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: children and tutors using V-Motive

The following intervention will be administered:

ABA therapy enhanced with V-Motive software

Tutors treating children with Applied Behavioral Analysis therapy will use the V-Motive software to enhance therapy sessions. Children will receive therapy as usual, but half of their current behavioral programs (skills/goals) will have been selected for enhanced prompting through video modeling.

Behavioral: ABA therapy enhanced with V-Motive software
Tutors will use the V-Motive software to enhance their delivery of Applied Behavioral Analysis therapy.




Primary Outcome Measures :
  1. Feasibility of V-Motive software's ability to positively impact a child's performance within 4 weeks [ Time Frame: 4-week trial starting in 2020 ]
    The following pilot feasibility measures will be captured for each tutor/child pair: 1) Usage: the total number of times the tutor chooses to use VM (an indicator that the tutor found it useful); 2) Overall Trial Success Rate: the percent of trials that were successful (e.g. recorded as a "pass") in programs with and without VM; 3) Mastery: the trials to criteria and the total number of targets mastered with and without VM; 4) Behavior Impact: the number of tantrums and other tracked behaviors occurring with and without VM (tracked by tutor using Abacus behavior tracker).


Secondary Outcome Measures :
  1. Amount of time required to construct a fully-indexed video repository from therapy footage using V-Motive [ Time Frame: 4-week trial starting in 2020 ]
    Researchers will measure the time it takes to construct the video repository for each tutor (time spent setting up camera, initializing the upload process, etc).

  2. Accuracy of V-Motive software in suggesting and cueing up appropriate video for playback on demand [ Time Frame: 4-week trial starting in 2020 ]
    The system will automatically capture the number of times a tutor adjusts the video for playback, number of times a video is rewound or fast-forwarded to obtain the appropriate start time, and the amount of time spent seeking before the video is cued up for playback to the child. For precision determination, actual start times will be obtained by manually reviewing the video of selected trials, and user seek times will be automatically tracked by the system.



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between 4 and 10 years old
  • Clinical diagnosis of Autism Spectrum Disorder
  • Currently receiving Applied Behavioral Analysis therapy
  • Must be developmentally capable of basic imitation behavior

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): NCT02500771


Contacts
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Contact: Rex Jakobovits, PhD 2065885811 rex@rexj.com

Locations
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United States, Washington
Northwest Behavioral Associates
Bellevue, Washington, United States, 98004
Contact: Stacey Shook, PhD, BCBA-D    425-822-6442    sshook@nba-autism.com   
Sponsors and Collaborators
Experiad LLC
northwest behavioral associates
Investigators
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Principal Investigator: Rex Jakobovits Experiad LLC
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Responsible Party: Rex Jakobovits, President, Experiad LLC
ClinicalTrials.gov Identifier: NCT02500771    
Other Study ID Numbers: VMOTIVE-1
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders