Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Sleep Coach Jr.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial with 2 conditions (intervention and usual care).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Usual Care | |
| Experimental: Sleep Coach Jr.<br>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. | Behavioral: Sleep Coach Jr.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | HbA1c, % glucose values in range | 3 months | 
| Parent Sleep Duration | Parent sleep duration (measured with actigraphy) | 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 |