Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Virginia Polytechnic Institute and State University

Study Protocol and Statistical Analysis Plan 
Title: Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum 
Disorder in Rural Southwest Virginia 
NCT#: NCT05822921 
Date of document: 8/18/2023 
 
 

 
Brief 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 primary aim remains the feasibility and satisfaction with psychoeducation, as this is a pilot 
feasibility study. The secondary aim will be significantly underpowered to analyze the 
differences between psychoeducation conditions (i.e., in-person vs. telehealth pychoeducation), 
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 changes in outcome measures (i.e., FES and ASK-Q).  
Protocol 
Participants: Participants will be recruited primarily from locales served by the Mount Rogers 
Community Services Board (MRCSB), including Smyth, Wythe, Bland, Carroll, and Grayson 
counties, and Galax City, in rural southwest Virginia, but we will also accept families from other 
local communities who contacted us to participate. We aim for 21 children between 2-15 years of 
age and one primary caregivers. Following a diagnostic feedback session, caregivers of children 
who receive an ASD diagnosis will be randomized to either attend psychoeducation sessions or 
receive comparable psychoeducation materials about ASD, with the goal of assessing feasibility 
and satisfaction of psychoeducation and of improving caregiver ASD knowledge and 
empowerment to seek and provide care for their child. Initially, families were going to be 
randomized to the following three psychoeducation conditions. Following the stay-at-home 
orders during the COVID-19 pandemic, however, we had to combine the first two conditions 
into one psychoeducation (PE) condition with clinician-led sessions. The psychoeducation as 
usual (PAU) condition, remained the same. 
1) In-person Psychoeducation Sessions: Caregivers in this group attended two 90-minute, 
in-person psychoeducation sessions on our mobile autism clinic (MAC), in or near their 
hometown. During these sessions, a clinician presented a series of psychoeducation topics 
supplemented with PowerPoint slides. The first session covered signs/symptoms of ASD, risk 
factors associated with developing ASD (e.g., heritability, neurobiology, social motivation), and 
navigating the service systems (e.g., Individualized Education Program (IEP) process, insurance, 
and Medicaid waivers), while the second psychoeducation session covered evidence-based best 
practices and a basic introduction to behavior management principles. This delivery method 
allowed caregivers an opportunity to ask questions and receive immediate, live, and detailed 
answers from an expert clinician, to focus on specific examples relevant to their child. 
2) Telehealth Psychoeducation Sessions: Caregivers in this group also attended two 90-
minute sessions, but remotely via a video chat platform, rather than in-person. Otherwise, it 
followed the same format and PowerPoint materials as the in-person group. Sessions were still 
facilitated by a clinician, thereby maintaining the option to ask questions, discuss personalized 
examples, etc. This telehealth method of delivery allowed for more flexibility in scheduling, as 
sessions could be conducted on days when the MAC was not in-service, but required additional 
consideration for families who did not have a computer and Internet access. In these cases, a 
family was randomized to one of the other two psychoeducation groups. 
3) Psychoeducation as usual (PAU) - Informational Materials: Caregivers in this group 
received basic paper psychoeducation resources, distributed at their feedback session. It was up 
to each caregiver how frequently and diligently they reviewed these resources, but they were 
encouraged to review them over the course of the following two weeks. These materials were 
intended to be akin to what a family might have access to at their pediatrician or primary care 
office, or perhaps on a website, if they were to look for ASD information on the Internet. To be 
consistent across study groups, the materials produced for these caregivers were comprehensive 
and included 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, caregivers 

were encouraged to reach out via phone or email if they had any questions, but only one 
caregiver did so. 
Procedures 
To track outcomes, caregivers completed a series of measures at five time points: (1) Time 1: 
intake, (2) Time 2: after feedback session, pre-psychoeducation, (3) Time 3: post-
psychoeducation (i.e., after the second psychoeducation session or equivalent time after feedback 
for PAU group), (4) Time 4: at 6-week follow-up from the end of psychoeducation, and (5) Time 
5: at 6-months follow-up from the end of psychoeducation. Times 1-4 consisted of measures of 
caregiver empowerment and ASD knowledge; Time 1 included measures of current services; 
Times 2-5 included a measure of new additional services since the prior timepoint; and Time 3 
also included a measure of satisfaction with the psychoeducation services. 
Measures 
Primary Outcome Measures 
Primary outcomes include the assessment of feasibility and satisfaction. 
 
Feasibility of the study will be assessed by tracking the number of parents who completed the 
psychoeducation sessions and the attrition from Time 2 to Time 3. 
 
Caregiver satisfaction with our psychoeducation services will be collected at Time 3 (the end of 
the final psychoeducation session or after two weeks of materials for the PAU group). This 
survey includes 32 questions on a 5-point Likert Scale from 0 (Completely Disagree) to 4 
(Completely Agree). This measure surveys areas of convenience, process, quality, interpersonal 
sensitivity, satisfaction with psychoeducation, and general satisfaction. Because scales have 
varying numbers of items, each subscale is calculated by adding the item scores and dividing by 
the number of items in that scale, for a mean score ranging from 0 to 4. For the current study, we 
will sum 5 items related specifically to the psychoeducation services, for a possible total of 20.  
Higher mean scores indicate greater satisfaction. 
 
Secondary Outcome Measures 
Family Empowerment Scale (FES; Koren et al., 1992) measures levels of perceived efficacy in 
areas such as community involvement and navigating services for the child and family. The FES 
is a 34-item questionnaire, providing a 5-point Likert scale for each item. The FES provides raw 
sums of the items within three domains of empowerment: Family (max = 60), Service System 
(max = 60), and Community/Political (max = 50). A higher raw score indicates greater 
empowerment in a given area. These factors are conceptually meaningful, congruence between 
them is high, and internal consistency is strong (.78-.89; Singh et al., 1995). In the current study, 
a sum total of all scales will be obtained, and a change score will be calculated between pre- and 
post-intervention. Positive scores indicate an increase in empowerment. 
 
Caregivers also reported on their ASD knowledge and beliefs on the Autism Stigma and 
Knowledge Questionnaire (ASK-Q; Harrison et al., 2017). The ASK-Q consists of 49 True/False 
statements, which comprise four subscales of ASD knowledge: diagnosis, etiology, treatment, 

and stigma, which results in a raw total score. The ASK-Q demonstrates strong internal 
consistency (.88). The knowledge subscales – diagnosis, etiology, and treatment – as well as the 
total score were used in this study. The items on this measure demonstrate strong face and 
construct validity, as well as cross-cultural utility. It also demonstrates strong discrimination 
between those who do and do not have adequate knowledge about ASD. In the current study, a 
sum total of all scales will be obtained, and a change score will be calculated between pre- and 
post-intervention. Positive scores indicate an increase in knowledge. 
 
Parents will complete a New Services Survey to assess additional services they have received 
since the prior timepoint. In the current study, we will calculate the number of families in each 
condition (PE and PAU) that added any new service across all timepoints for the duration of the 
study up to 6 months post-psychoeducation. 
 
Statistical Analysis Plan 
For Aim 1, the feasibility aim of this study, primary analyses will include tracking completion 
and attrition with the psychoeducation services across both groups: PE and PAU. These analyses 
will be descriptive only. Additionally, we will compare each group on satisfaction with the 
psychoeducation services. Independent t-tests will compare total satisfaction scores between the 
PE and PAU groups.  
For the second aim, we will assess the differential efficacy across the PE and PAU conditions on 
the measures of caregiver empowerment and ASD knowledge, as well as new services received. 
First, we will calculate the change score (Time 3 minus Time 2) for the FES total score and the 
ASK-Q total score to determine the change in empowerment and knowledge from pre- to post-
psychoeducation. Independent t-tests will compare the PE and PAU conditions on FES change 
score and on ASK-Q change score. To assess new services received, we will calculate the 
percent of families in each condition (PE and PAU) that indicated receiving a new service at any 
timepoint over the course of the study up to the 6-month follow-up. This analysis will be 
descriptive only.