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

NCT07375537 | Recruiting

• 1 other identifier: DH-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism

Keywords

Autism; Environmental modifications; Modifiable lifestyle factors; Parent coaching; Parent education

Outcome Measures

Primary Outcomes (1)

• Autism Treatment Evaluation Checklist (ATEC)

  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 Outcomes (5)

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

  Assessed at baseline, 6 months, and 12 months

• Short Sensory Profile 2

  Assessed at baseline, 6 months, and 12 months

• Children's Sleep Habits Questionnaire (CSHQ)

  Assessed at baseline, 6 months, and 12 months

• Goodenough Assessment of Child Drawing

  Assessed at baseline, 6 months, and 12 months

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

  Assessed at baseline, 6 months, and 12 months.

Other Outcomes (3)

• Parenting Stress Index-Short Form (PSI-SF)

  Assessed at baseline, 6 months, and 12 months.

• Quick Environmental Exposure and Sensitivity Inventory (QEESI)

  Assessed at baseline, 6 months, and 12 months.

• Environmental toxin and functional laboratory panel

  Assessed at baseline, 6 months, and 12 months

Study Arms (1)

Parent education and coaching program for newly diagnosed autism

EXPERIMENTAL

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

Interventions

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.

Parent education and coaching program for newly diagnosed autism

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Documenting Hope Project: lead

Study Sites (1)

Documenting Hope

Windsor, Connecticut, 06095, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Central Study Contacts

FLIGHT Study Administration

CONTACT

833-935-5543; info@documentinghope.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 29, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)