RecruitingNot ApplicableNCT07375537

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


Sponsor

Documenting Hope Project

Enrollment

12 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 7 Years

Inclusion Criteria7

  • 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

Exclusion Criteria6

  • 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

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Interventions

BEHAVIORALParent education and coaching program for newly diagnosed autism

Education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications.


Locations(1)

Documenting Hope

Windsor, Connecticut, United States

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NCT07375537


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