A 12-month parent education and health coaching program to address modifiable lifestyle and environmental factors for children with newly diagnosed autism
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
This program will test whether a year of parent education and health coaching can help families of children aged 3–7 with newly diagnosed moderate-to-severe autism improve lifestyle and environmental factors alongside usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Documenting Hope Project Academic / other |
| Locations | 1 site (Windsor, Connecticut) |
| Trial ID | NCT07375537 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label, prospective 12-month intervention that provides education and individualized health coaching to parents of 12 children newly diagnosed with autism. The program focuses on modifiable lifestyle factors and environmental changes used as an adjunct to comprehensive clinical care. Eligibility includes children aged 3–7 with a recent autism diagnosis and an ATEC score between 50 and 120, and parents who live in the United States and speak English. Feasibility and preliminary effectiveness outcomes will be collected over the year to inform larger future trials.
Who should consider this trial
Good fit: Ideal candidates are families in the United States with a child aged 3–7 recently diagnosed with autism (ATEC 50–120) whose parents speak English and are willing to engage in group and individual coaching and lifestyle changes.
Not a fit: Families already engaged in comprehensive diet, lifestyle, or environmental interventions for autism, or whose parents are unable or unwilling to participate in coaching or make lifestyle changes, are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could empower parents to make targeted lifestyle and environmental changes that may improve the well-being and daily functioning of their children.
How similar studies have performed: Some small or non-randomized parent education and coaching programs and lifestyle/environmental interventions have shown promise, but rigorous randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 as significant dietary changes 2. Parents who are unwilling or unable to participate in study activities, such as group and individual coaching 3. Parents who hold beliefs that are incompatible with an education and lifestyle intervention 4. 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 5. 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 6. Parents who are unable or unwilling to provide consent
Where this trial is running
Windsor, Connecticut
- Documenting Hope — Windsor, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: FLIGHT Study Administration
- Email: info@documentinghope.com
- Phone: 833-935-5543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.