Autism Spectrum DisorderNCT04518358
Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills
A study testing Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges in people with Autism Spectrum Disorder and Intellectual Disability, run by John T. Nosek at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability
- What is being tested?
- Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with Autism Spectrum Disorders and Intellectual Disabilities
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Being tested
- Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges
- Keywords
- expert software, behavioral intervention, Life Skill, Vocational Skill
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental ChallengesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Expert Guiding Technology | Experimental | Not described Receives: Behavioral: Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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 outcomes (2)
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- John T. Nosek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, John T. Nosek, Guiding Technologies Corporation
- Investigators
- John T Nosek, Ph.D., Principal investigator, Guiding Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518358
- Sponsor's protocol ID
- 1R43MH121230-01
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2020
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills
- ClinicalTrials.gov ID
- NCT04518358
- Acronym / sponsor ID
- 1R43MH121230-01
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Keywords
- expert software, behavioral intervention, Life Skill, Vocational Skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- John T. NosekIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Expert Guiding Technology | Experimental | Behavioral: Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with Autism Spectrum Disorders and Intellectual Disabilities
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental ChallengesDuring 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. | Behavioural | Evaluation of Expert Guiding Technology |
Primary outcome
Fidelity of Treatment Implementation SCED 1 Dyad 1 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 1 Dyad 2 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 1 Dyad 3 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 1 Dyad 4 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 2 Dyad 1 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 2 Dyad 2 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 2 Dyad 3 Instructor
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.
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.
Fidelity of Treatment Implementation SCED 2 Dyad 4 Instructor
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.
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.
Independent Completion of Steps SCED 1 Dyad 1 Adult With ASD
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.
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.
Independent Completion of Steps SCED 1 Dyad 2 Adult With ASD
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.
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.
Independent Completion of Steps SCED 1 Dyad 3 Adult With ASD
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.
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.
Independent Completion of Steps SCED 1 Dyad 4 Adult With ASD
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.
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.
Independent Completion of Steps SCED 2 Dyad 1 Adult With ASD
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.
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.
Independent Completion of Steps SCED 2 Dyad 2 Adult With ASD
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.
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.
Independent Completion of Steps SCED 2 Dyad 3 Adult With ASD
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.
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.
Independent Completion of Steps SCED 2 Dyad 4 Adult With ASD
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.
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.
2 secondary outcomes
Number of Sessions to Skill Acquisition SCED 1 Dyad 3 Adult With ASD
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
Number of Sessions to Skill Acquisition SCED 1 Dyad 4 Adult With ASD
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John T Nosek, Ph.D. principal investigator
Guiding Technologies Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges in people with Autism Spectrum Disorder and Intellectual Disability, run by John T. Nosek at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity of Treatment Implementation SCED 1 Dyad 1 Instructor (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.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.