NCT Number: NCT07458386
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.
Interested in participating?
Request Info3 year–12 year
All sexes
Observational
Brain Development, Biddenden, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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.
Life University
Other
A Complementary and Integrative Healthcare (CIH) Model for Children With Autism Spectrum Disorder-Related Symptoms: A Pilot Observational Study
Acronym: UNK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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