Skip to main content
OpenTrials
Completed

NCT Number: NCT06377384

FLIGHT Study for Childhood Chronic Illness

The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Epidemic Answers

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

  • At least one guardian must have the ability to read and write English
  • Participant and participant's caregiver must reside in the United States and live within the designated recruitment areas
  • Verified completion of the CHIRP survey and consent to participate in the FLIGHT Study screening process
  • Candidate's diagnosis(es) falls into one or more of the following categories:
  • Immune/Autoimmune Conditions (for example: juvenile idiopathic arthritis, juvenile rheumatoid arthritis, asthma, eczema, atopic illness, allergies, Crohn's disease, ulcerative colitis, other gastrointestinal disorders, lupus, other autoimmune conditions)
  • Conditions of Metabolic Dysregulation (for example: obesity/type 2 diabetes)
  • Mood/Behavioral/Developmental Conditions (for example: autism spectrum disorders, ADHD/ADD, depression, obsessive-compulsive disorder, anxiety)
  • Candidate is able to provide sufficient documentation of diagnoses, including validated/standardized diagnostic criteria in current use by specialists for each respective diagnosis, which have been performed by a professional with requisite experience or training

Exclusion criteria

  • Candidate is a family member or close associate of any employees or board members of Epidemic Answers, members of the FLIGHT Study Team, or any advisors or clinicians associated with the FLIGHT Study
  • Candidate is not able to provide documentation for proof of diagnoses
  • Diagnosis with a condition that is severe enough to preclude participation in the intensive, multi-modal lifestyle intervention
  • Caregiver(s) with health (e.g., serious chronic disease, disability, addiction) or other life circumstances (e.g., lack of transportation, shared custody of child) that preclude full participation in the intensive intervention
  • External sources of environmental toxicants to the home or school environment that cannot be modified (e.g., high tension power line directly adjacent to home, coal-fired power plant within a ¼ mile of family's home)
  • Inability to control/modify child's diet at daycare or with childcare provider
  • Caregiver(s) anticipate a change of geographic location within two years
  • Parent or caregiver has explicit belief that child's condition cannot be improved
  • Caregiver(s) unwilling to make lifestyle changes, restrict candidate's non-essential technology use. prepare the majority of the family meals at home, replace personal and household products if indicated
  • Caregiver(s) unwilling to have the candidate assessed by a team of doctors and/or healthcare practitioners including, but not limited to: physician, chiropractor, acupuncturist, optometrist, nutritionist, or other professionals recommend by the program
  • Caregiver(s) unwilling to have the candidate participate in minimally invasive laboratory or non-laboratory assessments
  • Caregiver(s) unwilling to have the candidate participate in required periodic video interviews, and other audio-visual documentation
  • Candidate is pregnant
  • Candidate has been convicted of a felony, is currently on probation, or in a juvenile detention center

Treatment and study plan

FLIGHT Intervention

Other

Personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care.

Primary outcomes

  1. Total Load Index (TLI)

    Time frame: Baseline and 18 months

    The TLI is a measure of environmental, chemical, and social stressors that interact to contribute to chronic illness. There is no numeric score.

Secondary outcomes

  1. Child Health Inventory for Resilience and Prevention (CHIRP)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

    Comprehensive survey evaluating total load of health stressors and supports influencing children. There is no numeric score.

  2. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

    Survey that assesses sleep. It consists of 35 items scored on a 1-3 point scale, with higher scores indicating worse sleep.

  3. Vineland Adaptive Behavior Scale

    Time frame: Baseline, 9 months, 18 months

    Survey assessing developmental and other disorders. A standard score of 100 is considered average, with scores above 100 indicating strengths in adaptive behavior and scores below 100 indicating areas of difficulty.

  4. Sensory Profile 2

    Time frame: Baseline, 9 months, 18 months

    Survey assessing child's sensory processing patterns. There are 86 items. For each item, a score of 0 indicates that the individual's sensory processing is consistent with age-based norms. Positive scores suggest that the individual's sensory processing is better than age-based norms, while negative scores indicate that the individual's sensory processing is weaker than age-based norms.

  5. Quick Environmental Exposure and Sensitivity Inventory (QEESI)

    Time frame: Baseline, 9 months, 18 months

    Survey that assesses environmental toxicants. The QEESI contains 50 items scored on a 0 to 10 scale with higher scores indicating greater environmental sensitivities.

  6. Hayward Environmental Illness Severity Scale

    Time frame: Baseline, 9 months, 18 months

    Survey assessing impact of home environment on health. The survey consists of 22 questions with total score ranges from 0 to 100. Higher scores indicating greater severity of environmenal sensitivity symptoms.

  7. Parenting Stress Index, 4th edition (PSI-4)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

    Survey assessing stress among parents. The PSI-4 contains 120 items with higher scores indicating greater levels of stress.

  8. Beck Anxiety Inventory (BAI)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

    Survey assessing anxiety. The survey contains 21 items with scores ranging from 0 to 63. Higher scores indicate greater levels of anxiety.

Sponsors and collaborators

Lead sponsor

Documenting Hope Project

Other

Registry information

Official study title

A Pilot and Feasibility Study Focusing on Lifestyle, Environmental Modifications, and Transdisciplinary Clinical Care for Children With Chronic Illness: Protocol for the FLIGHT Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Oct 6, 2025

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.

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