FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Factors fo… (NCT07375537) | Clinical Trial Compass
RecruitingNot Applicable
FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents
United States12 participantsStarted 2026-02-04
Plain-language 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. 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.
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Autism Treatment Evaluation Checklist (ATEC)
Timeframe: Assessed at baseline, six months, 12 months
. 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