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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Child Sleep Duration
Child sleep duration (measured with actigraphy)
Time frame: 3 months
Child Sleep Quality
Child sleep quality (measured with Child Sleep Habits Questionnaire)
Time frame: 3 months
Glycemic Control
HbA1c, % glucose values in range
Time frame: 3 months
Parent Sleep Duration
Parent sleep duration (measured with actigraphy)
Time frame: 3 months
Parental Well-being
Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)
Time frame: 3 months
Child Behavior Problems
Behavior problems measured with the Child Behavior Checklist (CBCL)
Time frame: 3 months
Parent Sleep Quality
and sleep quality (measured with Pittsburgh Sleep Quality Index)
Time frame: 3 months
Parental Fear of Hypoglycemia
Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)
Time frame: 3 months
Parental Diabetes Distress
Diabetes distress (Problem Area In Diabetes - Parental Version Revised)
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Time frame: 3 months