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

NCT05822921 | Completed Results

• 2 other identifiers: 19-423UL1TR003015
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (3)

In-person Psychoeducation

EXPERIMENTAL

Behavioral: In-person Psychoeducation (IP)

Telehealth Psychoeducation

EXPERIMENTAL

Behavioral: Telehealth Psychoeducation (TH)

Psychoeducation as Usual

ACTIVE COMPARATOR

Behavioral: Psychoeducation as Usual (PAU)

Interventions

In-person Psychoeducation (IP) BEHAVIORAL

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.

In-person Psychoeducation

Telehealth Psychoeducation (TH) BEHAVIORAL

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.

Telehealth Psychoeducation

Psychoeducation as Usual (PAU) BEHAVIORAL

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).

Psychoeducation as Usual

Eligibility Criteria

• Age: 16 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Autism Speaks: collaborator
• University of Virginia: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

Virginia Tech

Blacksburg, Virginia, 24060, United States

Location

Mount Rogers Community Services

Wytheville, Virginia, 24382, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Small sample size. In person and Zoom psychoeducation sessions were combined into one arm because COVID-19 pandemic necessitated a pivot to Zoom. As such, we had only completed 2 in person sessions before shifting to all Zoom sessions. Additionally, while 20 families were randomized to conditions, only 18 completed the post-psychoeducation measures, and only 15 completed the 6-month follow-up measures.

Results Point of Contact

• Title: Dr. Angela Scarpa
• Organization: Virginia Tech

ascarpa@vt.edu

540-231-2615

Study Officials

• Angela Scarpa, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials).

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: April 21, 2023
• Study Start: July 17, 2019
• Primary Completion: September 1, 2020
• Study Completion: March 12, 2021
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-10

Locations

US (2)