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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02500771
• Other study ID #: VMOTIVE-1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 9, 2015
• Last updated: July 14, 2015
• Start date: June 2017
• Est. completion date: December 2020

Study information

• Verified date: July 2015
• Source: Experiad LLC
• Contact: Rex Jakobovits, PhD
• Phone: 2065885811
• Email: rex[@]rexj.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
United States	Northwest Behavioral Associates	Bellevue	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Experiad LLC	northwest behavioral associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4-week trial starting in 2020	No
Secondary	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).	4-week trial starting in 2020	No
Secondary	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.	4-week trial starting in 2020	No