Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05822921
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2023-02-01
Brief Title:
Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
Sponsor:
Virginia Polytechnic Institute and State University
Organization:
Virginia Polytechnic Institute and State University
Study Overview
Official Title:
Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be the pilotfeasibility phase of a future clinical trial The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free through a mobile unit that travels to rural locations and telehealth assessments The diagnostic evaluation will confirm or rule out a diagnosis of ASD followed by purposeful ASD psychoeducation for parents whose children are diagnosed
Parents of children who meet criteria for a diagnosis of autism spectrum disorder ASD or are suspected to have ASD will be randomized into one of three groups ie in-person psychoeducation telehealth psychoeducation or psychoeducation as usual with paper psychoeducation materials Parents will complete outcome measures related to their satisfaction empowerment and autism spectrum disorder knowledge Changes in empowerment and ASD knowledge from pre- to post- psychoeducation will be measured using t-tests The investigators will also track if participants sought andor received additional ASD-related services throughout the study up to 6-months post-psychoeducation Results from this study will help to guide a future fully powered efficacy trial with a larger sample
Added April 2020 In light of the Virginia governors stay-at-home order in response to the COVID-19 outbreak the investigators are altering the protocol in line with the universitys request to move to remote conduct of research where possible as well as to continue to provide services to families in this time in line with Executive Order 53 from the VA Governor Parents in the latter half of the study conducted entirely remotely will be randomized into the two psychoeducation conditions telehealth or paper materials psychoeducation groups as in-person visits are not permitted Statistical analyses will be added to compare results between and within those who received in-person versus telehealth assessments The investigators and participants may return to in-person assessments if and when it is possible to do so but reserve the right to continue tele-assessment even once stay-at-home orders are lifted in order to fully answer the research aim of the feasibility and validity or tele-assessment procedures in ASD
Parents of children who meet criteria for a diagnosis of autism spectrum disorder ASD or are suspected to have ASD will be randomized into one of three groups ie in-person psychoeducation telehealth psychoeducation or psychoeducation as usual with paper psychoeducation materials Parents will complete outcome measures related to their satisfaction empowerment and autism spectrum disorder knowledge Changes in empowerment and ASD knowledge from pre- to post- psychoeducation will be measured using t-tests The investigators will also track if participants sought andor received additional ASD-related services throughout the study up to 6-months post-psychoeducation Results from this study will help to guide a future fully powered efficacy trial with a larger sample
Added April 2020 In light of the Virginia governors stay-at-home order in response to the COVID-19 outbreak the investigators are altering the protocol in line with the universitys request to move to remote conduct of research where possible as well as to continue to provide services to families in this time in line with Executive Order 53 from the VA Governor Parents in the latter half of the study conducted entirely remotely will be randomized into the two psychoeducation conditions telehealth or paper materials psychoeducation groups as in-person visits are not permitted Statistical analyses will be added to compare results between and within those who received in-person versus telehealth assessments The investigators and participants may return to in-person assessments if and when it is possible to do so but reserve the right to continue tele-assessment even once stay-at-home orders are lifted in order to fully answer the research aim of the feasibility and validity or tele-assessment procedures in ASD
Detailed Description:
This study will be the pilotfeasibility phase of a future clinical trial The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free through a mobile unit that travels to rural locations and telehealth assessments The diagnostic evaluation will confirm or rule out a diagnosis of ASD followed by purposeful ASD psychoeducation for parents whose children are diagnosed
Parents of children who meet criteria for a diagnosis of autism spectrum disorder ASD or are suspected to have ASD will be randomized into one of three groups ie in-person psychoeducation telehealth psychoeducation or psychoeducation as usual with paper psychoeducation materials Parents will complete outcome measures related to their satisfaction empowerment and autism spectrum disorder knowledge Changes in empowerment and ASD knowledge from pre- to post-psychoeducation will be measured using t-tests The investigators will also track if participants sought andor received additional ASD-related services throughout the study up to 6-months post-psychoeducation Results from this study will help to guide a future fully powered efficacy trial with a larger sample
Added April 2020
In light of the Virginia governors stay-at-home order in response to the COVID-19 outbreak which reached pandemic status approximately halfway through data collection all in-person research and clinical services have been paused at Virginia Tech as of March 13 2020 To continue to provide services to families in this time in line with Executive Order 53 from the VA Governor to ensure that the stay-at-home orders do not limit the provision of health care or medical services this study will begin exploring the feasibility of conducting tele-assessment a comprehensive assessment battery via a secure video platform and phone
As such the protocol is altered to be in line with the universitys request to move to remote conduct of research where possible For the remaining half of participants the investigators will replace the mobile assessment battery with a tele-assessment battery delivered via secure online video platform ZoomHIPAA andor by phone totaling up to 7 hours of assessment As such the protocol is revised to include tele-assessments no in-person assessments and randomly assigning eligible participants to either the telehealth or paper materials psychoeducation groups All outcome measures will remain the same but will be collected online or by telephone The investigators and participants may return to in-person assessments if and when it is possible but reserve the right to continue tele-assessment even once stay-at-home orders are lifted
The aims of the project will be altered somewhat by the updated procedure The study will be significantly underpowered to analyze the differences between psychoeducation conditions within and between each assessment modality ie in-person vs telehealth therefore in person and telehealth conditions will be combined into one psychoeducation PE group with clinician-led sessions The mean differences between the PE group and the psychoeducation as usual ie paper materials formats will be preliminarily explored in terms of both feasibility and satisfaction of the psychoeducation services and changes in outcome measures ie FES and ASK-Q Pending permission to return to in-person assessments analyses will also report alignment between diagnoses made via tele-assessment CARS-2 and ADI-R and a later in-person administration of the ADOS-2
Parents of children who meet criteria for a diagnosis of autism spectrum disorder ASD or are suspected to have ASD will be randomized into one of three groups ie in-person psychoeducation telehealth psychoeducation or psychoeducation as usual with paper psychoeducation materials Parents will complete outcome measures related to their satisfaction empowerment and autism spectrum disorder knowledge Changes in empowerment and ASD knowledge from pre- to post-psychoeducation will be measured using t-tests The investigators will also track if participants sought andor received additional ASD-related services throughout the study up to 6-months post-psychoeducation Results from this study will help to guide a future fully powered efficacy trial with a larger sample
Added April 2020
In light of the Virginia governors stay-at-home order in response to the COVID-19 outbreak which reached pandemic status approximately halfway through data collection all in-person research and clinical services have been paused at Virginia Tech as of March 13 2020 To continue to provide services to families in this time in line with Executive Order 53 from the VA Governor to ensure that the stay-at-home orders do not limit the provision of health care or medical services this study will begin exploring the feasibility of conducting tele-assessment a comprehensive assessment battery via a secure video platform and phone
As such the protocol is altered to be in line with the universitys request to move to remote conduct of research where possible For the remaining half of participants the investigators will replace the mobile assessment battery with a tele-assessment battery delivered via secure online video platform ZoomHIPAA andor by phone totaling up to 7 hours of assessment As such the protocol is revised to include tele-assessments no in-person assessments and randomly assigning eligible participants to either the telehealth or paper materials psychoeducation groups All outcome measures will remain the same but will be collected online or by telephone The investigators and participants may return to in-person assessments if and when it is possible but reserve the right to continue tele-assessment even once stay-at-home orders are lifted
The aims of the project will be altered somewhat by the updated procedure The study will be significantly underpowered to analyze the differences between psychoeducation conditions within and between each assessment modality ie in-person vs telehealth therefore in person and telehealth conditions will be combined into one psychoeducation PE group with clinician-led sessions The mean differences between the PE group and the psychoeducation as usual ie paper materials formats will be preliminarily explored in terms of both feasibility and satisfaction of the psychoeducation services and changes in outcome measures ie FES and ASK-Q Pending permission to return to in-person assessments analyses will also report alignment between diagnoses made via tele-assessment CARS-2 and ADI-R and a later in-person administration of the ADOS-2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR003015 | NIH | None | httpsreporternihgovquickSearchUL1TR003015 |