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Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual Care | |
| Sleep Coach Jr. | Experimental | Parents randomized to the intervention condition will receive a binder with the treatment manual, and the intervention will be administered in person (first session) and via telephone (second session) on an individual basis. The first session will focus on parent education and developing a positive bedtime routines, and the second session will be used to address barriers specific to the individual child. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Coach Jr. | Behavioral | A brief sleep education program for parents of school-aged children with type 1 diabetes, with a focus on resolving sleep disturbances with parent education and positive bedtime routines. |
| Measure | Description | Time Frame |
|---|---|---|
| Child Sleep Duration | Child sleep duration (measured with actigraphy) | 3 months |
| Child Sleep Quality | Child sleep quality (measured with Child Sleep Habits Questionnaire) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | HbA1c, % glucose values in range | 3 months |
| Parent Sleep Duration | Parent sleep duration (measured with actigraphy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized trial with 2 conditions (intervention and usual care).
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| 3 months |
| Parental Well-being | Well-Being Index (World Health Organization Five Well-Being Index, WHO-5) | 3 months |
| Child Behavior Problems | Behavior problems measured with the Child Behavior Checklist (CBCL) | 3 months |
| Parent Sleep Quality | and sleep quality (measured with Pittsburgh Sleep Quality Index) | 3 months |
| Parental Fear of Hypoglycemia | Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale) | 3 months |
| Parental Diabetes Distress | Diabetes distress (Problem Area In Diabetes - Parental Version Revised) | 3 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |