Treatment Planning for ABA Employing Auxiliary Tools V2+ (TREAAT2+)

NCT06204536 | Not Yet Recruiting Phase 1

• 1 other identifier: Mont_2023
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Technology enhancement in Applied Behavior Analysis (ABA) treatment planning may increase confidence, efficiency, consistency, and satisfaction for Board Certified Behavior Analysts (BCBAs) which, in turn, can provide for better clinical outcomes for patients on the autism spectrum. To this end, the investigators will examine the use of \>3 technology-based tools that will be implemented in the BCBAs' clinical workflow to aid with treatment planning. The study will initially involve two aims that are non-interventional (these processes will occur in the background and will have no impact on any cohorts), followed by an interventional aim that includes two arms (i.e., two BCBA cohorts). BCBAs within both arms will observe and practice the standard of care for ABA, and thus patient care will not be impacted. The outcome measures are primarily focused on the BCBAs as follows: Arm 1: An experimental group (BCBA Tech cohort) will receive the full tech package (TREAAT2+) from the start. Arm 2: The control group (BCBA non-Tech cohort) will not have access to any tools from the tech package for the first 6 months. In the subsequent 18 months, they will receive one tool every 6 months until gaining access to the entire tech package.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Autistic Disorder; Applied Behavior Analysis; Decision Support Systems, Clinical

Outcome Measures

Primary Outcomes (7)

• Retraining and upgrading the MLA (non-interventional)

  Performance of MLA as measured by AUROC, sensitivity, and specificity

  6 months

• Prospective evaluation of the app-integrated MLA (non-interventional)

  Attain substantial agreement between the treatment dosage prescribed by the BCBA and the dosage suggested by MLA, as measured by minimum inter-rater reliability (e.g., Cohen's Kappa) of greater than 0.6, which indicates substantial agreement according to the Landis and Koch's classification system.

  6 months

• Evaluate the impact of deploying the tech package within the BCBA workflow

  Endpoint: Efficiency (Qualitative). Demonstrate the efficacy of the tech package with statistically significant improvement (p \< 0.05) in efficiency at 6 month intervals. Likert questionnaires will be used to analyze answers to questions individually and the sum of the entire assessment measure will be the endpoint. The Likert Scale will be applied as (1) Strongly Disagree, (2) Disagree, (3) Neither Agree Nor Disagree (4) Agree, and (5) Strongly Agree. The minimum value of 1 indicates worse outcomes and the maximum value of 5 indicates best outcomes.

  24 months

• Evaluate the impact of deploying the tech package within the BCBA workflow

  Endpoint: Efficiency (Quantitative). Demonstrate the efficacy of the tech package with statistically significant improvement (p \< 0.05) in efficiency at 6 month intervals.The time allocated to treatment plan development by individual BCBAs for individual patients will be measured. The minimum and maximum values are represented by number of hours, with fewer hours (minimum value: 4 hours) associated with better outcomes (i.e., increased efficiency) and a higher number of hours (maximum value: 40 hours) associated with worse outcomes (i.e., no change or decreased efficiency).

  24 months

• Evaluate the impact of deploying the tech package within the BCBA workflow

  Endpoint: Confidence (Qualitative). Demonstrate the efficacy of the tech package with statistically significant improvement (p \< 0.05) in confidence at 6 month intervals. Likert questionnaires will be used to analyze answers to questions individually and the sum of the entire assessment measure will be the endpoint. The Likert Scale will be applied as (1) Strongly Disagree, (2) Disagree, (3) Neither Agree Nor Disagree (4) Agree, and (5) Strongly Agree. The minimum value of 1 indicates worse outcomes and the maximum value of 5 indicates best outcomes.

  24 months

• Evaluate the impact of deploying the tech package within the BCBA workflow

  Endpoint: Consistency (Qualitative). Demonstrate the efficacy of the tech package with statistically significant improvement (p \< 0.05) in consistency at 6 month intervals. Likert questionnaires will be used to analyze answers to questions individually and the sum of the entire assessment measure will be the endpoint. The Likert Scale will be applied as (1) Strongly Disagree, (2) Disagree, (3) Neither Agree Nor Disagree (4) Agree, and (5) Strongly Agree. The minimum value of 1 indicates worse outcomes and the maximum value of 5 indicates best outcomes.

  24 months

• Evaluate the impact of deploying the tech package within the BCBA workflow

  Endpoint: Satisfaction. Demonstrate the efficacy of the tech package with statistically significant improvement (p \< 0.05) in satisfaction at 6 month intervals. Likert questionnaires will be used to analyze answers to questions individually and the sum of the entire assessment measure will be the endpoint. The Likert Scale will be applied as (1) Strongly Disagree, (2) Disagree, (3) Neither Agree Nor Disagree (4) Agree, and (5) Strongly Agree. The minimum value of 1 indicates worse outcomes and the maximum value of 5 indicates best outcomes.

  24 months

Study Arms (2)

technology integrated care planning cohort

EXPERIMENTAL

This cohort will consist of 15 BCBAs that will receive a minimum of 3 technology-based tools (2 proprietary tools and at least 1 non-proprietary tool) for use in conjunction with the standard of care to develop and manage ABA treatment plans for active patients.

Other: Tech-enabled ABA treatment planning

non-technology integrated care cohort

NO INTERVENTION

This cohort will consist of 5 BCBAs that will follow the standard of care that does not involve the use of the tech-based tools to develop and manage ABA treatment plans for active patients receiving ABA.

Interventions

Tech-enabled ABA treatment planning OTHER

The tech-enabled ABA treatment planning will involve the use of a proprietary MLA integrated within a proprietary software application for use on a tablet, phone, or other smart device by BCBAs (one proprietary software application, one non-proprietary software application). The proprietary application provides functionality for treatment plan development, including templates and centralized resource availability. This tech will be used as adjunct or auxiliary tools to develop and manage ABA treatment plans. The proposed period of time for this intervention (the latter portion of the study subsequent to the non-interventional phases) will be 24 months.

technology integrated care planning cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BCBAs will be eligible for enrollment if they are actively employed by Montera and are actively providing ABA treatment to Montera patients.

You may not qualify if:

• BCBAs will be excluded from the study for one or more of the following reasons:
• BCBA requests that their data is not used in the study;
• BCBA does not complete the required assessments;

Sponsors & Collaborators

• Montera Health Texas LLC: lead

Related Publications (2)

• Maharjan J, Garikipati A, Dinenno FA, Ciobanu M, Barnes G, Browning E, DeCurzio J, Mao Q, Das R. Machine learning determination of applied behavioral analysis treatment plan type. Brain Inform. 2023 Mar 2;10(1):7. doi: 10.1186/s40708-023-00186-8.

  PMID: 36862316 BACKGROUND

• Garikipati A, Ciobanu M, Singh NP, Barnes G, Decurzio J, Mao Q, Das R. Clinical Outcomes of a Hybrid Model Approach to Applied Behavioral Analysis Treatment. Cureus. 2023 Mar 27;15(3):e36727. doi: 10.7759/cureus.36727. eCollection 2023 Mar.

  PMID: 36998917 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Qingqing Mao, PhD

CONTACT

4158051725; qmao@fortahealth.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The PI will not be aware of cohort assignments.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subsequent to conducting 2 non-interventional aims, the investigators will employ technology-based tools interventionally for the BCBAs for developing and managing an ABA treatment plan. The investigators divide the BCBAs into two interventional cohorts: one BCBA Tech cohort and one BCBA non-Tech cohort. The BCBA Tech cohort will have access to the full tech package from the start of this interventional aim; the BCBA non-Tech cohort will not have access to any tools from the tech package for the first 6 months. In the subsequent 18 months, they will receive one tool every 6 months until gaining access to the entire tech package.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share