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NCT05822921 · ClinicalTrials.gov registry record · NA
Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
A NA study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT05822921 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 21 participants.
The verdict
NCT05822921, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study will be the pilot/feasibility 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 (i.e., 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 and/or 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 governor's stay-at-home order in response to the COVID-19 outbreak, the investigators are altering the protocol in line with the university's 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 r
Interventions
- BEHAVIORAL In-person Psychoeducation (IP)
- BEHAVIORAL Telehealth Psychoeducation (TH)
- BEHAVIORAL Psychoeducation as Usual (PAU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-07-17 |
| Est. Completion | 2021-03-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05822921
The ClinicalTrials.gov registry entry for NCT05822921 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which In-person Psychoeducation (IP) is the first listed.
NCT05822921 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05822921 about?
NCT05822921 is a clinical study titled "Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia". This study will be the pilot/feasibility 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 diagnost...
What is the current status of trial NCT05822921?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2019-07-17. Estimated completion is 2021-03-12.
What interventions are being tested in trial NCT05822921?
The interventions under investigation include: In-person Psychoeducation (IP) (BEHAVIORAL), Telehealth Psychoeducation (TH) (BEHAVIORAL), Psychoeducation as Usual (PAU) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05822921?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
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