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

March 24, 2020 updated by: Sarah Jaser, Vanderbilt University Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: 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.
Behavioral: Sleep 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Sleep Duration
Time Frame: 3 months
Child sleep duration (measured with actigraphy)
3 months
Child Sleep Quality
Time Frame: 3 months
Child sleep quality (measured with Child Sleep Habits Questionnaire)
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

July 9, 2019

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 171902

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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