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NCT07375537Active, not recruiting

FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
12 (estimated)
First submitted
14 Jan 2026
Start date
4 Feb 2026
Primary completion date
29 Feb 2028
Lead sponsor
Documenting Hope Project
Diseases
Autism
NCT number
NCT07375537

What you commit to

  • Study type: Interventional
  • Planned participants: 12
  • From 4 Feb 2026 to the primary completion date, 29 Feb 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • 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
  • Parents who are unable or unwilling to provide consent

Who the study is looking for

  • 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

Age in the registry: 3 years to 7 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Documenting Hope
Coordinator of this site? Confirm its status
WindsorUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.