FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents
Running, not enrolling · Not applicable
Conditions studied: Autism
In brief
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.
Key facts
- Study ID
- NCT07375537
- Run by
- Documenting Hope Project
- People needed
- 12
- Starts
- 2026-02-04
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Documenting Hope — Windsor, Connecticut, United States
Full record on ClinicalTrials.gov
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