NCT06561581

Brief 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 delivery of autism behavioral therapy. Subjects will be staff recruited from existing Motivity customers.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 9, 2024

Last Update Submit

August 15, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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?

    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?

    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

    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?

    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?

    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.

    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.

    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.

    at the end of the study, expected to be 18 months from the start of retroactive observation period

Study Arms (2)

Acuity-Basic

OTHER
Behavioral: Acuity

Acuity-Enhanced

EXPERIMENTAL
Behavioral: Acuity

Interventions

AcuityBEHAVIORAL

Enhancement to Motivity product for clinical decision support

Also known as: Motivity
Acuity-BasicAcuity-Enhanced

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • All people not listed above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experiad LLC

Honolulu, Hawaii, 96816, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 20, 2024

Study Start

July 18, 2024

Primary Completion

August 31, 2024

Study Completion

July 31, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations