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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518358
• Other study ID #: 1R43MH121230-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2024
• Source: Guiding Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adults with Autism Spectrum Disorders and Intellectual Disabilities

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Intellectual Disability

Intervention

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.

Locations

Country	Name	City	State
United States	Chimes Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
John T. Nosek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fidelity of Treatment Implementation SCED 1 Dyad 1 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 1 Dyad 2 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 1 Dyad 3 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 1 Dyad 4 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 2 Dyad 1 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 2 Dyad 2 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 2 Dyad 3 Instructor	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 perform visual analysis.	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.
Primary	Fidelity of Treatment Implementation SCED 2 Dyad 4 Instructor	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 perform visual analysis.	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.
Primary	Independent Completion of Steps SCED 1 Dyad 1 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 1 Dyad 2 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 1 Dyad 3 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 1 Dyad 4 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 2 Dyad 1 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 2 Dyad 2 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 2 Dyad 3 Adult With ASD	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 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.
Primary	Independent Completion of Steps SCED 2 Dyad 4 Adult With ASD	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 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.
Secondary	Number of Sessions to Skill Acquisition SCED 1 Dyad 3 Adult With ASD	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
Secondary	Number of Sessions to Skill Acquisition SCED 1 Dyad 4 Adult With ASD	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