FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Fac
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 evalu
| Condition(s) | Autism |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Child from 3-7 years of age 2. 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 3. Child has an Autism Treatment Evaluation Checklist (ATEC) score at screening of between 50 and 120 (generally considered moderate/severe autism) 4. Child and parents live in the United States 5. Parent has ability to speak and read English 6. Parents are willing to fulfill study expectations 7. Child has not yet engaged in comprehensive diet, lifestyle, and environmental interventions for autism Exclusion Criteria: 1. Parents who are unwilling or unable to make lifestyle changes, such a |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Lead sponsor | Documenting Hope Project |
| Locations | Windsor, Connecticut, United States |
| Start date | 2026-02-04 |
| NCT ID | NCT07375537 |
| Official listing | https://clinicaltrials.gov/study/NCT07375537 |