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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822921
• Other study ID #: 19-423
• Secondary ID: UL1TR003015
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: March 12, 2021

Study information

• Verified date: October 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 12, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Months to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia
United States	Mount Rogers Community Services	Wytheville	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Autism Speaks, National Center for Advancing Translational Sciences (NCATS), University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance	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.	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)
Primary	Parent Satisfaction Assessed Via SATISFACTION SURVEY	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.	immediately post-intervention (4 weeks after baseline)
Secondary	Change in Parental Empowerment Assessed by the FAMILY EMPOWERMENT SCALE	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.	2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)
Secondary	Change in Parental Knowledge Assessed by AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE	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.	2 weeks from start of study (pre-psychoeducation) to 4 weeks from start of study (post-psychoeducation)
Secondary	Use of Additional Autism Spectrum Disorder-related Services Assessed by NEW SERVICES SURVEY	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.	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)