AutismNCT06561581
Acuity Functional Impact and Implementation Outcomes Evaluation
A study testing Acuity in people with Autism, run by Experiad LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Acuity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2024to 31 Jul 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All people not listed above
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Acuity
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcuityBehavioural
Also called Motivity
Enhancement to Motivity product for clinical decision support
| Study group | Role | What they receive |
|---|---|---|
| Acuity-Basic | Other | Not described Receives: Behavioral: Acuity |
| Acuity-Enhanced | Experimental | Not described Receives: Behavioral: Acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved estimation of Trials to Criterion and Time (days) to Criterion
Does Acuity make initial timeline estimates for sets of targets more accurate?
Measured: 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.
Does Acuity result in corrective action being taken more quickly for programs that are off schedule or targets that are exhibiting performance issues?
Measured: through study completion, expected to be 18 months from the start of retroactive observation period
Increased adherence to prescribed dosage
Does Acuity result in increased adherence to prescribed dosage, as measured by system
Measured: 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
Feasibility - To what extent are Acuity and its components practical or possible to use?
Measured: 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.
Adoption - What proportion of clinics and providers are willing to use Acuity and how well do they represent the population of clinics and providers?
Measured: 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.
Fidelity - the degree to which BAs and BTs use the system as expected, including dosage adherence, treatment planning accuracy, and timely protocol modification.
Measured: 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.
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.
Measured: 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.
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.
Measured: at the end of the study, expected to be 18 months from the start of retroactive observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Jul 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Experiad LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561581
- Sponsor's protocol ID
- Acuity-Study-1
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acuity Functional Impact and Implementation Outcomes Evaluation
- ClinicalTrials.gov ID
- NCT06561581
- Acronym / sponsor ID
- Acuity-Study-1
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Experiad LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acuity-Basic | Other | Behavioral: Acuity |
| Acuity-Enhanced | Experimental | Behavioral: Acuity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- All people not listed above
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 |
|---|---|---|
| AcuityAlso: MotivityEnhancement to Motivity product for clinical decision support | Behavioural | Acuity-Basic, Acuity-Enhanced |
Primary outcome
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?
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?
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
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?
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?
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuity in people with Autism, 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 3 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 20 Aug 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. 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 20 Aug 2024.