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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: Completed NA study, sponsored by Virginia Polytechnic Institute and State University.
NCT05822921 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Retention of participants assessed by parental attendance for all study sessions. Only parental attendance to psycho-education sessions was included for this measure. Child attendance was not needed.
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 |
What the finished NCT05822921 record still lists
NCT05822921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which In-person Psychoeducation (IP) is the first listed.
NCT05822921 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05822921's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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