Acuity Functional Impact and Implementation Outcomes Evaluation

August 15, 2024 updated by: Experiad LLC
This study will test feature enhancements to a behavioral therapy data collection software (Motivity) that will add a new clinical decision support module, called Acuity. Acuity is a Quality Improvement (QI) intervention targeted at Behavior Analysts (BAs) and Behavior Technicians (BTs) that aims to improve the delivery of autism behavioral therapy. Subjects will be staff recruited from existing Motivity customers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acuity is intended to provide significant improvements in treatment planning, progress tracking, trend monitoring, and dosage management. If successful, Acuity will provide Applied Behavior Analysis (ABA) practitioners with a higher level of real-time insight into their clinical data, enabling more efficient and productive treatment. Research has shown that first-generation systems fall short in supporting overworked BAs who are overwhelmed with data. Acuity will address critical shortfalls by enabling more agile corrective actions and data-driven planning across multiple aspects of treatment, providing practitioners with new levels of rigorous, real-time insight into their clinical data. Acuity will help BAs establish and adhere to realistic treatment timelines, and will proactively alert the BA to noteworthy trends in the data as they occur, such as learner performance issues, missed dosages, and significant changes in tracked behaviors. In doing so, Acuity will support more responsive and effective treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Experiad LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Behavior Analysts and Behavior Technicians treating kids with autism
  • Must be employed by one of the autism treatment clinics that have agreed to participate in the study.
  • Must be employed by Experiad customers who are using Motivity software as part of their practice.

Exclusion Criteria:

  • All people not listed above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Acuity-Basic
Behavioral: Acuity
Enhancement to Motivity product for clinical decision support
Other Names:
  • Motivity
Experimental: Acuity-Enhanced
Behavioral: Acuity
Enhancement to Motivity product for clinical decision support
Other Names:
  • Motivity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with improved estimation of Trials to Criterion and Time (days) to Criterion
Time Frame: through study completion, expected to be 18 months from the start of retroactive observation period
Does Acuity make initial timeline estimates for sets of targets more accurate?
through study completion, expected to be 18 months from the start of retroactive observation period
Increased frequency of changes to programs and prescribed dosages, resulting in reduced Trials to Criterion and Time to Criterion.
Time Frame: through study completion, expected to be 18 months from the start of retroactive observation period
Does Acuity result in corrective action being taken more quickly for programs that are off schedule or targets that are exhibiting performance issues?
through study completion, expected to be 18 months from the start of retroactive observation period
Increased adherence to prescribed dosage
Time Frame: through study completion, expected to be 18 months from the start of retroactive observation period
Does Acuity result in increased adherence to prescribed dosage, as measured by system
through study completion, expected to be 18 months from the start of retroactive observation period
Number of participants who find Acuity and its components practical and possible to use, assessed by qualitative measures and system usage tracking
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
Feasibility - To what extent are Acuity and its components practical or possible to use?
at the end of the study, expected to be 18 months from the start of retroactive observation period
Proportion of clinics and providers that actively use Acuity, assessed by system usage tracking.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
Adoption - What proportion of clinics and providers are willing to use Acuity and how well do they represent the population of clinics and providers?
at the end of the study, expected to be 18 months from the start of retroactive observation period
Number of BAs & BTs who utilize Acuity as intended to provide learners with accurate treatment plans, and achieve expected results, as measured by system usage and qualitative assessment.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
Fidelity - the degree to which BAs and BTs use the system as expected, including dosage adherence, treatment planning accuracy, and timely protocol modification.
at the end of the study, expected to be 18 months from the start of retroactive observation period
Majority of BAs and BTs rate Acuity and its components as attractive, agreeable, or palatable.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
Acceptability, as measured by SUS score and SUS Items 1, 5, 6 & 8 collected via online survey at the end of O0 & O1 from both arms.
at the end of the study, expected to be 18 months from the start of retroactive observation period
Frequency at which Acuity and its components are rated as suitable, fitting, or proper for achieving the goals set forth in treatment plans, as measured by surveys.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
Appropriateness - Same measures captured for all primary & secondary research questions in the Functional Impact Evaluation. Brief online survey with Likert scaled items focused on the providers' assessment of how well Acuity and its components are matched to the challenges of planning and executing Treatment Plans.
at the end of the study, expected to be 18 months from the start of retroactive observation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Experiad LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Acuity-Study-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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