Type 1 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
BEHAVIORALSleep Coach Jr.
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized trial with 2 conditions (intervention and usual care).
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* child between 5-9 years of age * child have been diagnosed with type 1 diabetes for at least 12 months * caregiver lives with child * caregiver can read/speak English
Exclusion criteria
* child has other major health problems or sleep disorders other than insufficient sleep or insomnia * participating in other intervention studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Sleep Duration | 3 months | Child sleep duration (measured with actigraphy) |
| Child Sleep Quality | 3 months | Child sleep quality (measured with Child Sleep Habits Questionnaire) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Well-being | 3 months | Well-Being Index (World Health Organization Five Well-Being Index, WHO-5) |
| Child Behavior Problems | 3 months | Behavior problems measured with the Child Behavior Checklist (CBCL) |
| Glycemic Control | 3 months | HbA1c, % glucose values in range |
| Parental Fear of Hypoglycemia | 3 months | Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale) |
| Parental Diabetes Distress | 3 months | Diabetes distress (Problem Area In Diabetes - Parental Version Revised) |
| Parent Sleep Quality | 3 months | and sleep quality (measured with Pittsburgh Sleep Quality Index) |
| Parent Sleep Duration | 3 months | Parent sleep duration (measured with actigraphy) |
Countries
United States
Outcome results
None listed