N/A
Completed N=20
Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia
Source: ClinicalTrials.gov NCT05822921 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Dec 2023
Primary outcomePrimary: Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance — 11; 9; 11; 9 parent-child pairs
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Parent-child Pairs Who Completed Study Sessions Assessed by Parental Attendance |
11; 9; 11; 9; 10; 8 | — |
| PRIMARY Parent Satisfaction Assessed Via SATISFACTION SURVEY |
19.5; 17.38 | .871 |
| SECONDARY Change in Parental Empowerment Assessed by the FAMILY EMPOWERMENT SCALE |
7; 7.88 | 0.896 |
| SECONDARY Change in Parental Knowledge Assessed by AUTISM STIGMA AND KNOWLEDGE QUESTIONNAIRE |
1.4; 0.5 | 0.351 |
| SECONDARY Use of Additional Autism Spectrum Disorder-related Services Assessed by NEW SERVICES SURVEY |
81.83; 55.56 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05822921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.