Autism Spectrum DisorderUNKNCT07458386
Complementary & Integrative Healthcare for Children With Autism: A Pilot Study
An observational study of Autism Spectrum Disorder, run by Life University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Mar 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 3-12 years of age
- Baseline ATEC score >71
Who cannot join
- History of epilepsy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
Brain Development
Biddenden
The Happy Healthy Unicorn
Maidstone
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Pediatrics, Naturopathy, Complementary Therapies, Pilot Projects
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: From enrollment to the end of the 6-month study period
Secondary outcomes (1)
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.
Measured: Baseline; ~1 month; ~3 months; ~4 months; ~6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start16 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyson Perez, DC, PhD, Life University
- Investigators
- Tyson Perez, DC, PhD, Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458386
- Sponsor's protocol ID
- EXPTP021626
- Acronym
- UNK
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD necessary to reproduce results
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Complementary and Integrative Healthcare (CIH) Model for Children With Autism Spectrum Disorder-Related Symptoms: A Pilot Observational Study
- ClinicalTrials.gov ID
- NCT07458386
- Acronym / sponsor ID
- UNK / EXPTP021626
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Pediatrics, Naturopathy, Complementary Therapies, Pilot Projects
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 3-12 years of age
- Baseline ATEC score >71
Key exclusion criteria (1 listed)
- History of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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'.
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'.
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'.
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'.
1 secondary outcome
Change in ATEC scores
Time frame: Baseline; ~1 month; ~3 months; ~4 months; ~6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD necessary to reproduce results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyson Perez, DC, PhD principal investigator
Life University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Life University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrollees who are eligible to participate (time frame: From enrollment to baseline ATEC submission (up to 48-hours).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.