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

March 17, 2026 updated by: Tyson Perez, DC, PhD, Life University

A Complementary and Integrative Healthcare (CIH) Model for Children With Autism Spectrum Disorder-Related Symptoms: A Pilot Observational Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Biddenden, United Kingdom
        • Brain Development
      • Maidstone, United Kingdom
        • The Happy Healthy Unicorn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- History of epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of enrollees who are eligible to participate
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'.
From enrollment to baseline ATEC submission (up to 48-hours).
Proportion of participants complying with instructions
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'.
From enrollment to the end of participation (up to 6-months)
Proportion of participants adhering to recommendations
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'.
From enrollment to the end of participation (up to 6-months)
Proportion of participants retained in the study
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'.
From enrollment to the end of the 6-month study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ATEC scores
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.
Baseline; ~1 month; ~3 months; ~4 months; ~6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life University

Investigators

  • Principal Investigator: Tyson Perez, DC, PhD, Life University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPTP021626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified IPD necessary to reproduce results

IPD Sharing Time Frame

(start date): within 1 year of study completion. (end date): indefinitely

IPD Sharing Access Criteria

IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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