Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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 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.

Key facts

Study ID

NCT05822921

Run by

Virginia Polytechnic Institute and State University

People needed

21

Starts

2019-07-17

Expected to finish

2021-03-12

Last updated by the study team

2023-12-22

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent(s)/Caregiver(s) to a child between the ages of 16 months through 17 years old with autism concern, who are seeking a diagnostic assessment, and live in a rural underserved community
• Recruitment in line with gender ratio seen in the prevalence of ASD (i.e., 4.2 boys to 1 girl)
• English-speaking parent
• Added April 2020: For the second half of the study (Tele-assessment), parents must have a computer, laptop, or tablet (at least 9.7 inches diagonally) with web-camera and stable Internet.

You may not qualify if…

• Children participants who will turn 18 before their participation in the study has ended
• If a family does not have Internet and computer access, the family will not be excluded, but will be randomized into a group other than the telehealth psychoeducation group.

Where it is running

• Virginia Tech — Blacksburg, Virginia, United States
• Mount Rogers Community Services — Wytheville, Virginia, United States

Full record on ClinicalTrials.gov

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