Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills
CompletedNAResults postedLast updated 26 April 2024
What this trial tests
NA trial testing Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges in Autism Spectrum Disorder in 16 participants. Completed in 31 August 2022.
Timeline
1 September 2019
Primary endpoint 31 August 2022
31 August 2022
Quick facts
Lead sponsor
John T. Nosek
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
na
Design
single group
Masking
none
Primary purpose
treatment
Enrollment
16
Start date
1 September 2019
Primary completion
31 August 2022
Estimated completion
31 August 2022
Sites
1 location across United States
Drugs / interventions tested
Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges
Eligibility, any sex, with Autism Spectrum Disorder or Intellectual Disability. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Fidelity of Treatment Implementation SCED 1 Dyad 1 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 1
33
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 1
11
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 1
55
Session 4 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 1
55
Session 5 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 1
77
Session 6 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 1
66
Session 7 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 1
75
Session 8 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 1
100
Fidelity of Treatment Implementation SCED 1 Dyad 2 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 2
33
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 2
55
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 2
100
Session 4 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 2
20
Session 5 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 2
86
Session 6 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 2
100
Session 7 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 2
100
Session 8 - Intervention
Group
Value
95% CI
SCED 1 Instructor Dyad 2
100
Fidelity of Treatment Implementation SCED 1 Dyad 3 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
100
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
55
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
44
Session 4 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
66
Session 5 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
88
Session 6 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
100
Session 7 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
77
Session 8 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 3
77
Fidelity of Treatment Implementation SCED 1 Dyad 4 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
33
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
55
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
33
Session 4 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
33
Session 5 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
55
Session 6 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
88
Session 7 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
77
Session 8 - Baseline
Group
Value
95% CI
SCED 1 Instructor Dyad 4
88
Fidelity of Treatment Implementation SCED 2 Dyad 1 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 1
0
Session 2 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 1
5.56
Session 3 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 1
0
Session 4 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 1
0
Session 5 - Intervention
Group
Value
95% CI
SCED 2 Instructor Dyad 1
0
Session 6 - Intervention
Group
Value
95% CI
SCED 2 Instructor Dyad 1
88.89
Session 7 - Intervention
Group
Value
95% CI
SCED 2 Instructor Dyad 1
77.78
Session 8 - Intervention
Group
Value
95% CI
SCED 2 Instructor Dyad 1
72.22
Fidelity of Treatment Implementation SCED 2 Dyad 2 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 2 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 3 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 4 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 5 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 6 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 7 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Session 8 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 2
0
Fidelity of Treatment Implementation SCED 2 Dyad 3 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
0
Session 2 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
0
Session 3 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
0
Session 4 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
0
Session 5 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
0
Session 6 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
11.11
Session 7 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
11.11
Session 8 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 3
0
Fidelity of Treatment Implementation SCED 2 Dyad 4 InstructorPrimary· 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 t
Session 1 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Session 2 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Session 3 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Session 4 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Session 5 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Session 6 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Session 7 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
22.22
Session 8 - Baseline
Group
Value
95% CI
SCED 2 Instructor Dyad 4
0
Independent Completion of Steps SCED 1 Dyad 1 Adult With ASDPrimary· 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.
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
22
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
33
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
55
Session 4 - Baseline
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
44
Session 5 - Baseline
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
77
Session 6 - Baseline
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
77
Session 7 - Intervention
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
33
Session 8 - Intervention
Group
Value
95% CI
SCED 1 Dyad 1 Adult With ASD
77
Independent Completion of Steps SCED 1 Dyad 2 Adult With ASDPrimary· 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.
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
22
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
44
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
55
Session 4 - Intervention
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
80
Session 5 - Intervention
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
66
Session 6 - Intervention
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
66
Session 7 - Intervention
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
77
Session 8 - Intervention
Group
Value
95% CI
SCED 1 Dyad 2 Adult With ASD
66
Independent Completion of Steps SCED 1 Dyad 3 Adult With ASDPrimary· 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.
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
66
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
77
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
33
Session 4 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
33
Session 5 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
66
Session 6 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
100
Session 7 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
88
Session 8 - Baseline
Group
Value
95% CI
SCED 1 Dyad 3 Adult With ASD
77
Independent Completion of Steps SCED 1 Dyad 4 Adult With ASDPrimary· 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.
Session 1 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
33
Session 2 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
55
Session 3 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
55
Session 4 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
44
Session 5 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
55
Session 6 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
77
Session 7 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
77
Session 8 - Baseline
Group
Value
95% CI
SCED 1 Dyad 4 Adult With ASD
55
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by John T. Nosek
Last refreshed: 26 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04518358.