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 will be measured within and between groups through a multilevel modeling (MLM) framework. The investigators will also track if participants sought and/or received additional ASD-related services throughout, and again at a 6-month follow-up. 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, 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 university's 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 and/or 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. 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, 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.~The aims of the project will be altered somewhat by the updated procedure. The aim to assess the feasibility and acceptability of mobile assessment and psychoeducation delivery remains, but will now also assess (and compare to) the feasibility and acceptability of tele-assessment services as outlined above. Additionally, the study will be significantly underpowered to analyze the differences between psychoeducation conditions within and between each assessment modality (i.e., in-person mobile assessment vs. telehealth), but the mean differences between the various formats will be preliminarily explored, in terms of both feasibility/acceptability of the services and changes in outcome measures. 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.
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 will be measured within and between groups through a multilevel modeling (MLM) framework. The investigators will also track if participants sought and/or received additional ASD-related services throughout, and again at a 6-month follow-up. 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.