Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills

May 3, 2023 updated by: John T. Nosek

Clinical trials will evaluate the efficacy of expert guiding technology to support instructors to better help individuals with developmental challenges due to ASD and ID learn life and vocational skills. Single Case Research Designs (SCRD) will be used to evaluate expert guiding technology interventions to support Task Analysis. SCRDs are a viable alternative to large group studies such as randomized clinical trials. Single case studies involve repeated measures, and manipulation of an independent variable. SCRD studies allow for rigorous experimental evaluation of intervention effects and provide a strong basis for establishing causal inferences.

Research design: A multiple baseline across tasks or participants will be used to evaluate the impact of the expert guiding technology on staff and consumers' performance.

Dependent Variables. DV1: Staff performance: The percentage of teaching steps correctly implemented will be calculated and monitored. The teaching steps are predetermined including what types of prompts will be used for each step of the task analysis of the identified consumer's adaptive living skills, record data on consumer's performance, and the timing of delivery of reinforcers and prompts. DV2: Consumers' performance: The percentage of Independent completion of the steps of task analyses for identified daily living skills will be calculated and monitored. The completed step is considered "independent" when the consumer completed the step without prompts from the staff within five seconds of the initial instruction (discriminative stimulus) given or the completion of the previous step. DV3: Consumers' performance: the amount of time taken to independent completion.

Independent Variable: Versions of expert guiding technology to support instructors in providing Task Analyses instruction while collecting data on consumer performance.

GAINS: During the GAINS sessions, the staff will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the staff throughout the sessions. This includes which prompt to use for each step, when to provide reinforcers, and which target task to work on. The system will also monitor the consumer's progress and notify the staff if the target task is mastered or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Applied Behavior Analysis (ABA) remains the most effective and scientifically-validated approach to remediate the deficits caused by Autism Spectrum Disorders (ASD) and intellectual disabilities (ID). Clinical trials will evaluate the efficacy of expert guiding technology to support instructors to better help individuals with developmental challenges due to ASD and ID learn life and vocational skills. Single Case Research Designs (SCRD) will be used to evaluate expert guiding technology interventions to support Task Analysis. SCRDs are a viable alternative to large group studies such as randomized clinical trials. Single case studies involve repeated measures, and manipulation of an independent variable. SCRD studies allow for rigorous experimental evaluation of intervention effects and provide a strong basis for establishing causal inferences.

Research design: A multiple baseline across tasks or participants will be used to evaluate the impact of the expert guiding technology on staff and consumers' performance.

Dependent Variables. DV1: Staff performance: The percentage of teaching steps correctly implemented will be calculated and monitored. The teaching steps are predetermined including what types of prompts will be used for each step of the task analysis of the identified consumer's adaptive living skills, record data on consumer's performance, and the timing of delivery of reinforcers and prompts. DV2: Consumers' performance: The percentage of Independent completion of the steps of task analyses for identified daily living skills will be calculated and monitored. The completed step is considered "independent" when the consumer completed the step without prompts from the staff within five seconds of the initial instruction (discriminative stimulus) given or the completion of the previous step. DV3: Consumers' performance: the amount of time taken to independent completion.

Independent Variable: Versions of expert guiding technology to support instructors in providing Task Analyses instruction while collecting data on consumer performance.

GAINS: During the GAINS sessions, the staff will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the staff throughout the sessions. This includes which prompt to use for each step, when to provide reinforcers, and which target task to work on. The system will also monitor the consumer's progress and notify the staff if the target task is mastered or not.

Procedural fidelity: procedural fidelity checklist will be implemented to ensure the accuracy of implementation of baseline and intervention procedures. The percentage of accurate implementation will be calculated by dividing the number of steps implemented accurately by the total steps of procedures multiplying by 100.

Develop and conduct survey of staff and consumers to evaluate social validity of expert guiding technology.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • 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 Contact

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19711
        • Chimes Delaware

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Adults with Autism Spectrum Disorders and Intellectual Disabilities

Exclusion Criteria:

- none

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation of Expert Guiding Technology
Behavioral: Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges
During the GAINS sessions, the Direct Support Professional (DSP) will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the DSP throughout sessions. This includes which prompt to use for each step of the target skill, when to provide reinforcers, and which target task to work on. The system will also monitor the participant's (adults with ASD/ID) progress and notify the DSP if the target skill is mastered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fidelity of Treatment Implementation
Time Frame: Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two
One dependent measure is the fidelity of the teaching protocol implemented by DSPs. Each teaching protocol is comprised of a series of specific steps. Fidelity of the teaching protocol will be evaluated through collection of "yes" responses for accurately following the protocol and "no" responses for not accurately following the protocol for each step of the chain. The percentage of accurate implementation of the protocol will be calculated by dividing the steps marked with "yes" by the total number of the steps (sum of steps with "yes" and "no") and multiplied by 100. Data will be collected through multiple trials in order to make visual and statistical analysis valuable.
Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two
Independent Completion of Steps
Time Frame: Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two
Each target skill performed by adults with ASD/ID will be task analyzed. Tasks analysis involves breaking the skill down into smaller steps. The percentage of independent completion of steps will be calculated by dividing the number of independently completed steps by the total number of steps and multiplying by 100. Data will be captured through multiple trials to make visual and statistical analysis possible.
Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Sessions to Skill Acquisition
Time Frame: Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two
In addition to the level of independence of adults with ASD/ID, the number of sessions required for them to acquire the target skill will be monitored. The criterion of skill acquisition is 90% or above of independent completion of steps for three consecutive sessions.
Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two

Collaborators and Investigators

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

Sponsor

John T. Nosek

Investigators

  • Principal Investigator: John T Nosek, Ph.D., Guiding Technologies Corporation

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)

September 1, 2019

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R43MH121230-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any identifying information will be omitted from published or disseminated reports of the data to maintain confidentiality of subjects. Results of the study may be shared through conference presentations or written reports disseminated in peer-reviewed journals or other formats (e.gs., book chapters or grant proposals). In such cases, pseudonyms will be used and no identifying information (e.g., geographical location of subjects' residences) will be included when discussing results.

IPD Sharing Time Frame

Available by the end of the project and for at least a year.

IPD Sharing Access Criteria

Requests reviewed by the research team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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