search
Back to results

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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Coach Jr.
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Sleep Coach Jr.

Arm Description

Usual Care

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.

Outcomes

Primary Outcome Measures

Child Sleep Duration
Child sleep duration (measured with actigraphy)
Child Sleep Quality
Child sleep quality (measured with Child Sleep Habits Questionnaire)

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2018
Last Updated
March 24, 2020
Sponsor
Vanderbilt University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03397147
Brief Title
Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
Official Title
Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial with 2 conditions (intervention and usual care).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
Sleep Coach Jr.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Coach Jr.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child Sleep Duration
Description
Child sleep duration (measured with actigraphy)
Time Frame
3 months
Title
Child Sleep Quality
Description
Child sleep quality (measured with Child Sleep Habits Questionnaire)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Glycemic Control
Description
HbA1c, % glucose values in range
Time Frame
3 months
Title
Parent Sleep Duration
Description
Parent sleep duration (measured with actigraphy)
Time Frame
3 months
Title
Parental Well-being
Description
Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)
Time Frame
3 months
Title
Child Behavior Problems
Description
Behavior problems measured with the Child Behavior Checklist (CBCL)
Time Frame
3 months
Title
Parent Sleep Quality
Description
and sleep quality (measured with Pittsburgh Sleep Quality Index)
Time Frame
3 months
Title
Parental Fear of Hypoglycemia
Description
Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)
Time Frame
3 months
Title
Parental Diabetes Distress
Description
Diabetes distress (Problem Area In Diabetes - Parental Version Revised)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs