Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children (3-12) with ASD-Related Symptoms | 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 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'. | 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'. | 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'. | From enrollment to the end of the 6-month study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- History of epilepsy
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Development | Biddenden | United Kingdom | ||||
| The Happy Healthy Unicorn |
Deidentified IPD necessary to reproduce results
(start date): within 1 year of study completion. (end date): indefinitely
IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline; ~1 month; ~3 months; ~4 months; ~6 months |
| Maidstone |
| United Kingdom |