NCT02500771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

3.5 years

First QC Date

July 9, 2015

Last Update Submit

July 14, 2015

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Amount of time required to construct a fully-indexed video repository from therapy footage using V-Motive

    4-week trial starting in 2020

  • Accuracy of V-Motive software in suggesting and cueing up appropriate video for playback on demand

    4-week trial starting in 2020

Study Arms (1)

children and tutors using V-Motive

EXPERIMENTAL

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

Interventions

ABA therapy enhanced with V-Motive softwareBEHAVIORAL

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

children and tutors using V-Motive

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Behavioral Associates

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rex Jakobovits

    Experiad LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rex Jakobovits, PhD

CONTACT

2065885811rex@rexj.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 17, 2015

Study Start

June 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

US(1)