Autism Spectrum DisorderNCT02500771
Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
A study testing ABA therapy enhanced with V-Motive software in people with Autism Spectrum Disorder, run by Experiad LLC at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ABA therapy enhanced with V-Motive software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Behavioral Associates
Bellevue, Washington, 98004
Stacey Shook, PhD, BCBA-D, 425-822-6442, sshook@nba-autism.com
About this study
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.
Read the 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?
- Conditions
- Autism Spectrum Disorder
- Being tested
- ABA therapy enhanced with V-Motive software
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABA therapy enhanced with V-Motive softwareBehavioural
Tutors will use the V-Motive software to enhance their delivery of Applied Behavioral Analysis therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ABA therapy enhanced with V-Motive software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 4-week trial starting in 2020
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.
Measured: 4-week trial starting in 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJun 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Experiad LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- northwest behavioral associates
- Responsible party
- Principal investigator, Rex Jakobovits, Experiad LLC
- Investigators
- Rex Jakobovits, Principal investigator, Experiad LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500771
- Sponsor's protocol ID
- VMOTIVE-1
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1
- ClinicalTrials.gov ID
- NCT02500771
- Acronym / sponsor ID
- VMOTIVE-1
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Experiad LLCIndustry (pharma, biotech, devices)
- Collaborators
- northwest behavioral associates
- Study start
- Jun 2017
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children and tutors using V-Motive | Experimental | Behavioral: ABA therapy enhanced with V-Motive softwareThe 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABA therapy enhanced with V-Motive softwareTutors will use the V-Motive software to enhance their delivery of Applied Behavioral Analysis therapy. | Behavioural | children and tutors using V-Motive |
Primary outcome
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).
2 secondary outcomes
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
Accuracy of V-Motive software in suggesting and cueing up appropriate video for playback on demand
Time frame: 4-week trial starting in 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rex Jakobovits principal investigator
Experiad LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABA therapy enhanced with V-Motive software in people with Autism Spectrum Disorder, run by Experiad LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rex Jakobovits, PhD (2065885811, rex@rexj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.