An observational study in Autism Spectrum Disorder, sponsored by Life University. Enrolling by invitation at 2 sites in United Kingdom. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Life University · Observational
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.
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 20 is below the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Life University is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
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Children aged 3-12 years whose parents/caregivers identify the presence of symptoms associated with autism spectrum disorder (ASD; e.g., challenges in communication, social interaction, or repetitive behaviors). A formal clinical diagnosis is not required for inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- History of epilepsy
Children aged 3-12 years whose parents/caregivers identify the presence of symptoms associated with autism spectrum disorder (ASD; e.g., challenges in communication, social interaction, or repetitive behaviors). A formal clinical diagnosis is not required for inclusion
Proportion of enrollees who are eligible to participate
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 baseline ATEC submission (up to 48-hours).
Proportion of participants complying with instructions
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)
Proportion of participants adhering to recommendations
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 participation (up to 6-months)
Proportion of participants retained in the study
The number of participants submitting the 5th and final ATEC, divided by the total number of participants. This assesses 'Retention'.
Time frame: From enrollment to the end of the 6-month study period
Change in ATEC scores
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.
Time frame: Baseline; ~1 month; ~3 months; ~4 months; ~6 months
Plan to share: Yes — Deidentified IPD necessary to reproduce results
Supporting information: Analytic code
Time frame: (start date): within 1 year of study completion. (end date): indefinitely
Access criteria: IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository
Data sharing details ↗ · figshare.com
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