Epidemic Answers
Windsor, Connecticut, 06095, United States
NCT Number: NCT06377384
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.
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Notify Me2 year–15 year
All sexes
Interventional
Phase 1
Windsor, Connecticut, 06095, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Documenting Hope Project
Other
A Pilot and Feasibility Study Focusing on Lifestyle, Environmental Modifications, and Transdisciplinary Clinical Care for Children With Chronic Illness: Protocol for the FLIGHT Study
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.
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