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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLIGHT Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLIGHT Intervention | Other | Personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Load Index (TLI) | The TLI is a measure of environmental, chemical, and social stressors that interact to contribute to chronic illness. There is no numeric score. | Baseline and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Child Health Inventory for Resilience and Prevention (CHIRP) | Comprehensive survey evaluating total load of health stressors and supports influencing children. There is no numeric score. | Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months |
| Children's Sleep Habits Questionnaire (CSHQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epidemic Answers | Windsor | Connecticut | 06095 | United States |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Survey that assesses sleep. It consists of 35 items scored on a 1-3 point scale, with higher scores indicating worse sleep. |
| Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months |
| Vineland Adaptive Behavior Scale | 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. | Baseline, 9 months, 18 months |
| Sensory Profile 2 | 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. | Baseline, 9 months, 18 months |
| Quick Environmental Exposure and Sensitivity Inventory (QEESI) | Survey that assesses environmental toxicants. The QEESI contains 50 items scored on a 0 to 10 scale with higher scores indicating greater environmental sensitivities. | Baseline, 9 months, 18 months |
| Hayward Environmental Illness Severity Scale | 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. | Baseline, 9 months, 18 months |
| Parenting Stress Index, 4th edition (PSI-4) | Survey assessing stress among parents. The PSI-4 contains 120 items with higher scores indicating greater levels of stress. | Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months |
| Beck Anxiety Inventory (BAI) | Survey assessing anxiety. The survey contains 21 items with scores ranging from 0 to 63. Higher scores indicate greater levels of anxiety. | Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months |