Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills
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| ClinicalTrials.gov Identifier: NCT04518358 |
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Recruitment Status :
Recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autism Spectrum Disorder Intellectual Disability | Behavioral: Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges | Not Applicable |
Applied Behavior Analysis (ABA) remains the most effective and scientifically-validated approach to remediate the deficits caused by Autism Spectrum Disorders (ASD) and intellectual disabilities (ID). Clinical trials will evaluate the efficacy of expert guiding technology to support instructors to better help individuals with developmental challenges due to ASD and ID learn life and vocational skills. Single Case Research Designs (SCRD) will be used to evaluate expert guiding technology interventions to support Task Analysis. SCRDs are a viable alternative to large group studies such as randomized clinical trials. Single case studies involve repeated measures, and manipulation of an independent variable. SCRD studies allow for rigorous experimental evaluation of intervention effects and provide a strong basis for establishing causal inferences.
Research design: A multiple baseline across tasks or participants will be used to evaluate the impact of the expert guiding technology on staff and consumers' performance.
Dependent Variables. DV1: Staff performance: The percentage of teaching steps correctly implemented will be calculated and monitored. The teaching steps are predetermined including what types of prompts will be used for each step of the task analysis of the identified consumer's adaptive living skills, record data on consumer's performance, and the timing of delivery of reinforcers and prompts. DV2: Consumers' performance: The percentage of Independent completion of the steps of task analyses for identified daily living skills will be calculated and monitored. The completed step is considered "independent" when the consumer completed the step without prompts from the staff within five seconds of the initial instruction (discriminative stimulus) given or the completion of the previous step. DV3: Consumers' performance: the amount of time taken to independent completion.
Independent Variable: Versions of expert guiding technology to support instructors in providing Task Analyses instruction while collecting data on consumer performance.
GAINS: During the GAINS sessions, the staff will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the staff throughout the sessions. This includes which prompt to use for each step, when to provide reinforcers, and which target task to work on. The system will also monitor the consumer's progress and notify the staff if the target task is mastered or not.
Procedural fidelity: procedural fidelity checklist will be implemented to ensure the accuracy of implementation of baseline and intervention procedures. The percentage of accurate implementation will be calculated by dividing the number of steps implemented accurately by the total steps of procedures multiplying by 100.
Develop and conduct survey of staff and consumers to evaluate social validity of expert guiding technology.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 8 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | August 31, 2021 |
| Estimated Study Completion Date : | August 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Evaluation of Expert Guiding Technology |
Behavioral: Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges
During the GAINS sessions, the Direct Support Professional (DSP) will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the DSP throughout sessions. This includes which prompt to use for each step of the target skill, when to provide reinforcers, and which target task to work on. The system will also monitor the participant's (adults with ASD/ID) progress and notify the DSP if the target skill is mastered. |
- Fidelity of Treatment Implementation [ Time Frame: Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two ]One dependent measure is the fidelity of the teaching protocol implemented by DSPs. Each teaching protocol is comprised of a series of specific steps. Fidelity of the teaching protocol will be evaluated through collection of "yes" responses for accurately following the protocol and "no" responses for not accurately following the protocol for each step of the chain. The percentage of accurate implementation of the protocol will be calculated by dividing the steps marked with "yes" by the total number of the steps (sum of steps with "yes" and "no") and multiplied by 100. Data will be collected through multiple trials in order to make visual and statistical analysis valuable.
- Independent Completion of Steps [ Time Frame: Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two ]Each target skill performed by adults with ASD/ID will be task analyzed. Tasks analysis involves breaking the skill down into smaller steps. The percentage of independent completion of steps will be calculated by dividing the number of independently completed steps by the total number of steps and multiplying by 100. Data will be captured through multiple trials to make visual and statistical analysis possible.
- Number of Sessions to Skill Acquisition [ Time Frame: Single Case Research Design (SCRD): Multiple Baselines Repeated Measures Design. Repeated measures in baselines and repeated measures in the intervention will be taken after each intervention of the technology for approximately 3 weeks. There will be two ]In addition to the level of independence of adults with ASD/ID, the number of sessions required for them to acquire the target skill will be monitored. The criterion of skill acquisition is 90% or above of independent completion of steps for three consecutive sessions.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with Autism Spectrum Disorders and Intellectual Disabilities
Exclusion Criteria:
- none
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518358
| Contact: John T Nosek, Ph.D. | 609-605-9273 | john.nosek@guidingtechnologies.com |
| United States, Delaware | |
| Chimes Delaware | Recruiting |
| Newark, Delaware, United States, 19711 | |
| Contact: Lois Meszaros, Ph.D. 302-452-3400 lois.meszaros@chimes.org | |
| Principal Investigator: | John T Nosek, Ph.D. | Guiding Technologies Corporation |
| Responsible Party: | John T. Nosek, President & CEO, Guiding Technologies Corporation |
| ClinicalTrials.gov Identifier: | NCT04518358 |
| Other Study ID Numbers: |
1R43MH121230-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 19, 2020 Key Record Dates |
| Last Update Posted: | August 19, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Any identifying information will be omitted from published or disseminated reports of the data to maintain confidentiality of subjects. Results of the study may be shared through conference presentations or written reports disseminated in peer-reviewed journals or other formats (e.gs., book chapters or grant proposals). In such cases, pseudonyms will be used and no identifying information (e.g., geographical location of subjects' residences) will be included when discussing results. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Available by the end of the project and for at least a year. |
| Access Criteria: | Requests reviewed by the research team. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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expert software behavioral intervention Life Skill Vocational Skill |
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Intellectual Disability Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders |
Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |