Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABA therapy enhanced with V-Motive software
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility 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
Sites / Locations
- Northwest Behavioral Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
children and tutors using V-Motive
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility of V-Motive software's ability to positively impact a child's performance within 4 weeks
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
Amount of time required to construct a fully-indexed video repository from therapy footage using V-Motive
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).
Accuracy of V-Motive software in suggesting and cueing up appropriate video for playback on demand
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.
Full Information
NCT ID
NCT02500771
First Posted
July 9, 2015
Last Updated
July 14, 2015
Sponsor
Experiad LLC
Collaborators
northwest behavioral associates
1. Study Identification
Unique Protocol Identification Number
NCT02500771
Brief Title
Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
Official Title
Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Experiad LLC
Collaborators
northwest behavioral associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children and tutors using V-Motive
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ABA therapy enhanced with V-Motive software
Intervention Description
Tutors will use the V-Motive software to enhance their delivery of Applied Behavioral Analysis therapy.
Primary Outcome Measure Information:
Title
Feasibility of V-Motive software's ability to positively impact a child's performance within 4 weeks
Description
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).
Time Frame
4-week trial starting in 2020
Secondary Outcome Measure Information:
Title
Amount of time required to construct a fully-indexed video repository from therapy footage using V-Motive
Description
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).
Time Frame
4-week trial starting in 2020
Title
Accuracy of V-Motive software in suggesting and cueing up appropriate video for playback on demand
Description
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.
Time Frame
4-week trial starting in 2020
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rex Jakobovits, PhD
Phone
2065885811
Email
rex@rexj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rex Jakobovits
Organizational Affiliation
Experiad LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Behavioral Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Shook, PhD, BCBA-D
Phone
425-822-6442
Email
sshook@nba-autism.com
12. IPD Sharing Statement
Learn more about this trial
Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
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