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

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.

Conditions

• Autism Spectrum Disorder

Interventions

BEHAVIORAL

In-person Psychoeducation (IP)

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.

BEHAVIORAL

Telehealth Psychoeducation (TH)

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.

BEHAVIORAL

Psychoeducation as Usual (PAU)

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).

Sponsors & Collaborators

• Autism Speaks

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Virginia Polytechnic Institute and State University

  lead OTHER

Principal Investigators

• Angela Scarpa, PhD · Virginia Polytechnic Institute and State University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-17

Primary Completion

2020-09-01

Completion

2021-03-12

Countries

• United States

Study Locations