FLIGHT Study for Childhood Chronic Illness

Phase 1

Recruiting

• Conditions: Chronic Illnesses, Multiple

• Registration Number: NCT06377384
• Lead Sponsor: Documenting Hope Project

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total Load Index (TLI)	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 Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (BAI)	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.
Child Health Inventory for Resilience and Prevention (CHIRP)	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.
Children's Sleep Habits Questionnaire (CSHQ)	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.
Quick Environmental Exposure and Sensitivity Inventory (QEESI)	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.
Vineland Adaptive Behavior Scale	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.
Sensory Profile 2	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.
Hayward Environmental Illness Severity Scale	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.
Parenting Stress Index, 4th edition (PSI-4)	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.

Trial Locations

Locations (1)

Epidemic Answers; 🇺🇸 Windsor, Connecticut, United States