Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07375537

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Documenting Hope

Windsor, Connecticut, 06095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Parent education and coaching program for newly diagnosed autism

Behavioral

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

Primary outcomes

  1. Autism Treatment Evaluation Checklist (ATEC)

    Time frame: Assessed at baseline, six months, 12 months

    The assessment consists of four subtests: Speech/Language Communication (14 items), Sociability (20 items), Sensory/Cognitive Awareness (18 items), and Health/Physical/Behavior (25 items). Each item is rated on a scale from 0 (no problem) to 3 (severe problem), with total scores ranging from 0 to 180. Lower scores indicate less autism symptom severity.

Secondary outcomes

  1. Behavior Assessment System for Children, Third Edition (BASC-3)

    Time frame: Assessed at baseline, 6 months, and 12 months

    Score range: 0 to 100. Interpretation: Lower scores indicate fewer problematic behaviors.

  2. Short Sensory Profile 2

    Time frame: Assessed at baseline, 6 months, and 12 months

    Raw scores are converted to percentiles. Lower scores indicate fewer sensory behaviors.

  3. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: Assessed at baseline, 6 months, and 12 months

    Score range 45-135. Lower scores indicate less sleep disturbance.

  4. Goodenough Assessment of Child Drawing

    Time frame: Assessed at baseline, 6 months, and 12 months

    Scores range from 40 to 160. Higher scores indicate greater developmental level.

  5. Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24)

    Time frame: Assessed at baseline, 6 months, and 12 months.

    No single summed score, as food intake is assessed without maximums or minimums. Lower intake of ultraprocessed foods is the desired outcome.

Other outcomes

  1. Parenting Stress Index-Short Form (PSI-SF)

    Time frame: Assessed at baseline, 6 months, and 12 months.

    Total scores range from 36-180. Lower scores indicate less parental stress.

  2. Quick Environmental Exposure and Sensitivity Inventory (QEESI)

    Time frame: Assessed at baseline, 6 months, and 12 months.

    Scores range from 0-100 for each scale. Lower scores indicate less severe symptoms.

  3. Environmental toxin and functional laboratory panel

    Time frame: Assessed at baseline, 6 months, and 12 months

    Exploratory analysis of environmental toxin and functional laboratory panel. Higher levels indicate worse environmental toxin and functional status. A composite toxin burden ("low", "medium", "high") will be assessed across the panel.

Sponsors and collaborators

Lead sponsor

Documenting Hope Project

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.