NCT03919721

Brief Summary

This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism.

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 Nov 2019

Shorter than P25 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

March 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

March 19, 2019

Last Update Submit

April 15, 2019

Conditions

Keywords

applied behavioral analysisdata collection software

Outcome Measures

Primary Outcomes (6)

  • Impact of software on number of updates to programs made by behavior analysts (intervention agility)

    Comparing the frequency of program updates between electronic programs and paper programs

    Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)

  • Event tracking usability assessed by user ratings

    Number of tutors who rate it highly on likert scale

    Likert scale to be administered at the end of study (8 weeks from start date)

  • Program editing efficiency as assessed by usage analysis

    Comparison of total time spent editing electronic programs vs paper programs.

    Time will be tracked continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)

  • Impact of software on trial success rate

    Comparison of overall trial success rate (percent of trails meeting success threshold) in electronic administered programs compared to paper administered programs

    Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)

  • Impact of software on trials to criterion (number of trials needed to achieve mastery)

    Comparison of trials to criterion (number of trials needed to achieve mastery) in electronic administered programs compared to paper administered programs

    Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)

  • Impact of software on total number of targets mastered

    Comparison of total number of targets mastered in electronic administered programs compared to paper administered programs

    Data will be collected continuously from start to end of study; totals will be analyzed at the end of study (8 weeks from start date)

Study Arms (1)

Learners receiving Applied Behavior Analysis therapy

EXPERIMENTAL

All children enrolled in the study will already receiving therapy. Each BT-child pair will have worked together regularly for at least 3 months prior to the study.

Behavioral: Applied Behavioral Analysis

Interventions

Children are receiving Applied Behavioral Analysis therapy to treat their autism. Therapy is comprised of 15-20 discrete programs that are intended to shape specific behaviors. Tutors collect data on child's performance towards goals. For each child, some of the programs will be tracked with paper data collection methods, others will use electronic data collection. This study is to test the usefulness of the electronic data collection system to replace paper in existing interventions.

Learners receiving Applied Behavior Analysis therapy

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Child receiving applied behavior analysis at participating institution to treat autism disorder

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

Related Links

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rex Rex, PhD

    Experiad Solutions

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rex Jakobovits, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All children enrolled in the study will already receiving ABA therapy Each tutor-child pair will have worked together regularly for at least 3 months prior to the study. Each child will have 15-20 active therapy programs, each of which will be randomly assigned to one of two sets: the experimental (Motivity-enabled) or control (therapy-as-usual). For the control set, BTs will use their existing methods, either paper-based or a competitor's data collection system. Tutors will use Motivity for 8 weeks in therapy under supervision in a single case-study pilot.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

April 18, 2019

Study Start

November 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations