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

NCT ID: NCT04518358

Last Updated: 2024-04-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Intellectual Disability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A multiple probe design across participants will be used. This design necessitates a minimum of three participants to demonstrate experimental control, however 8 will be recruited. The small-N design yields much higher power and inferential validity than a traditional between-subject design, allowing for a much smaller n. The eight adults with ASD/ID will be divided into two groups, with four participants per group, which creates two sets of multiple probe designs. Baseline data will be collected for all participants (fidelity of treatment implementation for DSPs and independent completion of steps for adults with ASD/ID) for a minimum of three-to-five sessions prior to implementation of the intervention. Baseline data collection will continue until stability is achieved through each data point not exceeding 20% of mean responding during baseline. The intervention will be implemented in a staggered manner within each group in order to assess the effects of the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evaluation of Expert Guiding Technology

Group Type EXPERIMENTAL

Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- Adults with Autism Spectrum Disorders and Intellectual Disabilities

Exclusion Criteria

\- none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John T. Nosek

INDUSTRY

Sponsor Role lead

Responsible Party

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John T. Nosek

President & CEO

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John T Nosek, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Guiding Technologies Corporation

Locations

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Chimes Delaware

Newark, Delaware, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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1R43MH121230-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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