AutismNCT07375537
FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents
A study testing Parent education and coaching program for newly diagnosed autism in people with Autism, run by Documenting Hope Project at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the feasibility and effectiveness of an education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism
- What is being tested?
- Parent education and coaching program for newly diagnosed autism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to Feb 2028
- Phase
- Interventional
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child from 3-7 years of age
- Child has autism diagnosis featuring evaluation with the Autism Diagnostic Observation Schedule, 2nd Edition [ADOS-2], Childhood Autism Rating Scale, Second Edition (CARS-2), or Autism Diagnostic Interview - Revised (ADI-R) within the last 18 months
- Child has an Autism Treatment Evaluation Checklist (ATEC) score at screening of between 50 and 120 (generally considered moderate/severe autism)
- Child and parents live in the United States
- Parent has ability to speak and read English
- Parents are willing to fulfill study expectations
- Child has not yet engaged in comprehensive diet, lifestyle, and environmental interventions for autism
Who cannot join
- Parents who are unwilling or unable to make lifestyle changes, such as significant dietary changes
- Parents who are unwilling or unable to participate in study activities, such as group and individual coaching
- Parents who hold beliefs that are incompatible with an education and lifestyle intervention
- Child who requires significant specialty medical care, including routine or frequent in-patient medical treatment, are currently taking mood stabilizing drugs, and/or who have cancer or a pre-cancerous condition
- Child who has been diagnosed with complex conditions in addition to autism, such as an inborn error of metabolism identified through genetic testing, or a known chromosomal disorder
- Parents who are unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FLIGHT - Autism: An Open-Label, Prospective Study Evaluating the Feasibility and Effectiveness of an Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents of Children With Newly Diagnosed Autism
The primary purpose of this study is to evaluate the feasibility and effectiveness of an education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. A single-arm, open-label, prospective study will be conducted evaluating the feasibility and effectiveness of the 12-month education and health coaching intervention for parents as an adjuvant to comprehensive clinical care for 12 newly diagnosed children with autism.
- Conditions
- Autism
- Being tested
- Parent education and coaching program for newly diagnosed autism
- Keywords
- Autism, Environmental modifications, Modifiable lifestyle factors, Parent coaching, Parent education
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent education and coaching program for newly diagnosed autismBehavioural
Education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications.
| Study group | Role | What they receive |
|---|---|---|
| Parent education and coaching program for newly diagnosed autism | Experimental | Education and coaching program for parents of children with newly diagnosed autism focused on modifiable lifestyle factors and environmental modifications Receives: Behavioral: Parent education and coaching program for newly diagnosed autism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Treatment Evaluation Checklist (ATEC)
The assessment consists of four subtests: Speech/Language Communication (14 items), Sociability (20 items), Sensory/Cognitive Awareness (18 items), and Health/Physical/Behavior (25 items). Each item is rated on a scale from 0 (no problem) to 3 (severe problem), with total scores ranging from 0 to 180. Lower scores indicate less autism symptom severity.
Measured: Assessed at baseline, six months, 12 months
Secondary outcomes (5)
Behavior Assessment System for Children, Third Edition (BASC-3)
Score range: 0 to 100. Interpretation: Lower scores indicate fewer problematic behaviors.
Measured: Assessed at baseline, 6 months, and 12 months
Short Sensory Profile 2
Raw scores are converted to percentiles. Lower scores indicate fewer sensory behaviors.
Measured: Assessed at baseline, 6 months, and 12 months
Children's Sleep Habits Questionnaire (CSHQ)
Score range 45-135. Lower scores indicate less sleep disturbance.
Measured: Assessed at baseline, 6 months, and 12 months
Goodenough Assessment of Child Drawing
Scores range from 40 to 160. Higher scores indicate greater developmental level.
Measured: Assessed at baseline, 6 months, and 12 months
Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24)
No single summed score, as food intake is assessed without maximums or minimums. Lower intake of ultraprocessed foods is the desired outcome.
Measured: Assessed at baseline, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start4 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Documenting Hope Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375537
- Sponsor's protocol ID
- DH-002
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study of outcomes among children with autism represents a vulnerable population.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLIGHT - Autism: An Open-Label, Prospective Study Evaluating the Feasibility and Effectiveness of an Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents of Children With Newly Diagnosed Autism
- ClinicalTrials.gov ID
- NCT07375537
- Acronym / sponsor ID
- DH-002
- Conditions
- Autism
- Keywords
- Autism, Environmental modifications, Modifiable lifestyle factors, Parent coaching, Parent education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Documenting Hope ProjectUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 Jan 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.
The primary purpose of this study is to evaluate the feasibility and effectiveness of an education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. A single-arm, open-label, prospective study will be conducted evaluating the feasibility and effectiveness of the 12-month education and health coaching intervention for parents as an adjuvant to comprehensive clinical care for 12 newly diagnosed children with autism.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent education and coaching program for newly diagnosed autism | Experimental | Behavioral: Parent education and coaching program for newly diagnosed autismEducation and coaching program for parents of children with newly diagnosed autism focused on modifiable lifestyle factors and environmental modifications |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child from 3-7 years of age
- Child has autism diagnosis featuring evaluation with the Autism Diagnostic Observation Schedule, 2nd Edition [ADOS-2], Childhood Autism Rating Scale, Second Edition (CARS-2), or Autism Diagnostic Interview - Revised (ADI-R) within the last 18 months
- Child has an Autism Treatment Evaluation Checklist (ATEC) score at screening of between 50 and 120 (generally considered moderate/severe autism)
- Child and parents live in the United States
- Parent has ability to speak and read English
Key exclusion criteria (6 listed)
- Parents who are unwilling or unable to make lifestyle changes, such as significant dietary changes
- Parents who are unwilling or unable to participate in study activities, such as group and individual coaching
- Parents who hold beliefs that are incompatible with an education and lifestyle intervention
- Child who requires significant specialty medical care, including routine or frequent in-patient medical treatment, are currently taking mood stabilizing drugs, and/or who have cancer or a pre-cancerous condition
- Child who has been diagnosed with complex conditions in addition to autism, such as an inborn error of metabolism identified through genetic testing, or a known chromosomal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent education and coaching program for newly diagnosed autismEducation and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. | Behavioural | Parent education and coaching program for newly diagnosed autism |
Primary outcome
Autism Treatment Evaluation Checklist (ATEC)
Time frame: Assessed at baseline, six months, 12 months
The assessment consists of four subtests: Speech/Language Communication (14 items), Sociability (20 items), Sensory/Cognitive Awareness (18 items), and Health/Physical/Behavior (25 items). Each item is rated on a scale from 0 (no problem) to 3 (severe problem), with total scores ranging from 0 to 180. Lower scores indicate less autism symptom severity.
5 secondary outcomes
Behavior Assessment System for Children, Third Edition (BASC-3)
Time frame: Assessed at baseline, 6 months, and 12 months
Short Sensory Profile 2
Time frame: Assessed at baseline, 6 months, and 12 months
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Assessed at baseline, 6 months, and 12 months
Goodenough Assessment of Child Drawing
Time frame: Assessed at baseline, 6 months, and 12 months
Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24)
Time frame: Assessed at baseline, 6 months, and 12 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 16 Jul 2026.
- Individual participant dataSharing planned: No. This study of outcomes among children with autism represents a vulnerable population.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent education and coaching program for newly diagnosed autism in people with Autism, run by Documenting Hope Project at 1 site in United States.
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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Autism Treatment Evaluation Checklist (ATEC) (time frame: Assessed at baseline, six months, 12 months). 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 16 Jul 2026.