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

NCT07458386 | Enrolling By Invitation

• 1 other identifier: EXPTP021626
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Pediatrics; Naturopathy; Complementary Therapies; Pilot Projects

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Change in ATEC scores

  Baseline; ~1 month; ~3 months; ~4 months; ~6 months

Study Arms (1)

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

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years of age
• Baseline ATEC score \>71

You may not qualify if:

• \- History of epilepsy

Sponsors & Collaborators

• Life University: lead

Study Sites (2)

Brain Development

Biddenden, United Kingdom

Location

The Happy Healthy Unicorn

Maidstone, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tyson Perez, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 9, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

GB (2)