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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Sleep Coach Jr.

• Registration Number: NCT03397147
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-11
• Study Start: 2018-07-05
• Primary Completion: 2019-04-01
• Study Completion: 2019-07-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• child has other major health problems or sleep disorders other than insufficient sleep or insomnia
• participating in other intervention studies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Coach Jr.	Sleep Coach Jr.	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.

Primary Outcome Measures

Name	Time	Method
Child Sleep Quality	3 months	Child sleep quality (measured with Child Sleep Habits Questionnaire)
Child Sleep Duration	3 months	Child sleep duration (measured with actigraphy)

Secondary Outcome Measures

Name	Time	Method
Parent Sleep Quality	3 months	and sleep quality (measured with Pittsburgh Sleep Quality Index)
Child Behavior Problems	3 months	Behavior problems measured with the Child Behavior Checklist (CBCL)
Parental Fear of Hypoglycemia	3 months	Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)
Glycemic Control	3 months	HbA1c, % glucose values in range
Parent Sleep Duration	3 months	Parent sleep duration (measured with actigraphy)
Parental Diabetes Distress	3 months	Diabetes distress (Problem Area In Diabetes - Parental Version Revised)
Parental Well-being	3 months	Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States