Complementary & Integrative Healthcare for Children With Autism: A Pilot Study

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.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 3 Years to 12 Years

Inclusion Criteria:

* 3-12 years of age
* Baseline ATEC score >71

Exclusion Criteria:

\- History of epilepsy

• Tyson Perez, DC, PhD, Principal investigator, Life University