Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder, Pediatrics, Naturopathy, Complementary Therapies, Pilot Projects
Brief summary
To investigate the feasibility of implementing an online assessment battery in tandem with normal & customary complementary & integrative healthcare (CIH) provided to children with autism. The secondary aim is to assess the potential impacts of CIH on clinical outcomes.
Detailed description
The main aim of this pilot observational study is to investigate the feasibility of implementing an online assessment battery in tandem with normal & customary, fee-for-service, remotely delivered complementary & integrative healthcare (CIH, i.e., naturopathy + functional neurological rehabilitation) provided to children with significant parent-reported autism spectrum disorder (ASD)-related symptoms. The primary outcomes are 1) eligibility, 2) compliance, 3) adherence, and 4) retention. A secondary/exploratory aim is to assess the potential clinical impacts of CIH via a validated parent-reported outcome measure (i.e., Autism Treatment & Evaluation Checklist; ATEC). Data from this study will inform the feasibility of a definitive study powered to assess the effectiveness of CIH care on clinical outcomes in a pediatric population with ASD-related symptoms.
Interventions
None listed
Sponsors
Life University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 3-12 years of age * Baseline ATEC score \>71
Exclusion criteria
\- History of epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of enrollees who are eligible to participate | From enrollment to baseline ATEC submission (up to 48-hours). | The number of enrollees (i.e., participants who consent) who score \>71 on the baseline Autism Treatment \& Evaluation Checklist (ATEC), divided by the total number of enrollees. This assesses 'Eligibility'. |
| Proportion of participants complying with instructions | From enrollment to the end of participation (up to 6-months) | The number of participants submitting all online ATECs within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'. |
| Proportion of participants adhering to recommendations | From enrollment to the end of participation (up to 6-months) | The number of participants attending ≥90% of scheduled online check-ins with the CIH practitioners, divided by the total number of participants. This assesses 'Adherence'. |
| Proportion of participants retained in the study | From enrollment to the end of the 6-month study period | The number of participants submitting the 5th and final ATEC, divided by the total number of participants. This assesses 'Retention'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ATEC scores | Baseline; ~1 month; ~3 months; ~4 months; ~6 months | Change in ATEC scores from baseline. The ATEC is a 77-item parent-report questionnaire encompassing four distinct domains (i.e., speech/language, sociability, sensory/cognitive awareness, \& health/physical/behavior) designed to track the progress of individuals with ASD-related symptoms. Total scores on the ATEC range from 0 to 179 with higher scores indicating greater severity of symptoms. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORTyson Perez, DC, PhD
Life University
Outcome results
None listed