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

April 7, 2026 updated by: Documenting Hope Project

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Windsor, Connecticut, United States, 06095
        • Recruiting
        • Documenting Hope
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent education and coaching program for newly diagnosed autism
Education and coaching program for parents of children with newly diagnosed autism focused on modifiable lifestyle factors and environmental modifications
Behavioral: Parent 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at baseline, six months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at baseline, 6 months, and 12 months
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.
Assessed at baseline, 6 months, and 12 months
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.
Assessed at baseline, 6 months, and 12 months
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.
Assessed at baseline, 6 months, and 12 months
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.
Assessed at baseline, 6 months, and 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at baseline, 6 months, and 12 months.
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.
Assessed at baseline, 6 months, and 12 months.
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.
Assessed at baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Documenting Hope Project

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study of outcomes among children with autism represents a vulnerable population.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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