Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: In-person Psychoeducation (IP)Behavioral: Telehealth Psychoeducation (TH)Behavioral: Psychoeducation as Usual (PAU)
- Registration Number
- NCT05822921
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description In-person Psychoeducation In-person Psychoeducation (IP) - Telehealth Psychoeducation Telehealth Psychoeducation (TH) - Psychoeducation as Usual Psychoeducation as Usual (PAU) -
- Primary Outcome Measures
Name Time Method Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance Time 1: Baseline/intake (0 weeks); Time 2: Pre-intervention (2 weeks); Time 3: Immediately post-intervention (4 weeks after baseline); Time 4: 6- week followup (10 weeks after baseline); Time 5: 6-month followup (7 months after baseline) Retention of participants assessed by parental attendance for all study sessions. Only parental attendance to psycho-education sessions was included for this measure. Child attendance was not needed.
Parent Satisfaction Assessed Via SATISFACTION SURVEY immediately post-intervention (4 weeks after baseline) SATISFACTION SURVEY: A satisfaction survey will be administered to elicit parents' feedback on our service.Satisfaction survey administered immediately post-psychoeducation, on a scale of 0=completely disagree to 4= completely agree with statements about satisfaction with psychoeducation received, ability to function day to day, learning throughout materials, ability to handle situations with child in future, and ability to gain a better outlook on life with child. Total sum scores were used, for a range of 0 to 20, with higher scores indicating greater satisfaction.
- Secondary Outcome Measures
Name Time Method Use of Additional Autism Spectrum Disorder-related Services Assessed by NEW SERVICES SURVEY Time 2: pre-intervention (2 weeks after baseline), Time 3: immediately post-intervention (4 weeks after baseline), Time 4: 6-week followup (10 weeks after baseline), to Time 5: 6-month followup (7 months after baseline) Use of additional Autism Spectrum Disorder-related services accessed will be assessed using a NEW SERVICES SURVEY. Parents will be surveyed as to what new services have been used since the last session or survey time point. This survey will ask whether parents have contacted other service agencies, the date of contact, whether they received any new services (and to specify the services received), and the date of first service received.
Change in Parental Empowerment Assessed by the FAMILY EMPOWERMENT SCALE 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation) Parental empowerment will be assessed by the Family Empowerment Scale and compared across education delivery formats. The Family Empowerment Scale measures levels of perceived efficacy in community involvement, navigating services for child and family. This scale includes three areas (family domain, service system domain, and community/political domain). Range of scores per domain include: family domain (12 to 60), service system domain (12 to 60), and community/political domain (10 to 50). Total sum scores could range from 34 - 170. A higher score indicates greater empowerment in a given domain. Change in sum total score across all domains from pre- to post-psychoeducation was used for analysis.
Change in Parental Knowledge Assessed by AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE 2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation) Parental knowledge will be assessed using the AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE. Total sum scores range from minimum score = 0 to maximum score = 48. A higher raw score is better and indicates more autism knowledge and less autism stigma. Change score from pre- to post- psychoeducation was used for analysis.
Trial Locations
- Locations (2)
Mount Rogers Community Services
🇺🇸Wytheville, Virginia, United States
Virginia Tech
🇺🇸Blacksburg, Virginia, United States