Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

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 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 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,
      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. 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 (i.e., 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 (i.e., paper materials) formats will be preliminarily explored, in terms of both
      feasibility and satisfaction of the psychoeducation services and changes in outcome measures
      (i.e., 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.
    

Intervention name(s): In-person Psychoeducation (IP); Telehealth Psychoeducation (TH); Psychoeducation as Usual (PAU)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Parents will attend two 60-minute (i.e. one day per week, for the next two weeks), in-person psychoeducation sessions on the MAC, in or near their hometown. During these sessions, a clinician will discuss a series of psychoeducation topics supplemented with PowerPoint slides. Across the two sessions, the following topics will be covered: (1) signs/symptoms and epidemiology of ASD, (2) risk factors associated with developing ASD (e.g., genetics, neurobiology, environment, social motivation), (3) navigating the IEP process, and (4) evidence-based best practices recommended for their child's profile of ASD symptoms and co-occurring conditions. This delivery method will allow parents to ask questions and receive immediate, live, and detailed answers from an expert clinician, to focus on specific examples relevant to their child, and to foster ASD knowledge and efficacy in helping their child.; Parents in this group will attend two 60-minute sessions, remotely via a live video chat platform, rather than in-person. Otherwise, it will follow the same format and PowerPoint materials as the IP Group. Sessions will still be facilitated by a clinician, thus maintaining the option to ask questions, discuss personalized examples, etc. For families without computer and internet access, the family will be assisted with to connecting to internet access at a private and convenient location (e.g., a church, library, or local community services agency). In the event that this is not possible, the family will be randomized to one of the other two groups.; Parents in this group will receive basic paper psychoeducation resources, distributed at their feedback session. It will be up to each parent how frequently and diligently these resources are reviewed. This should be akin to what a family might have access to at their pediatric or primary care office. To be consistent across study groups, the materials produced for these parents will be comprehensive and will include the same span of content as the PowerPoint slides used in the other two groups, but without structured sessions facilitated by a clinician. Upon distribution of materials, parents will be provided with our contact information and encouraged to reach out if any questions occur. Parents in the paper informational materials group will have the option to complete two in-person or video conference psychoeducation sessions after the end of the study, if preferred (i.e., 6 months later).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials).
Masking: None (Open Label)
Primary purpose: Health Services Research