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

NCT03397147 | Completed

• 1 other identifier: 171902
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Glycemic Control

  3 months

• Parent Sleep Duration

  3 months

• Parental Well-being

  3 months

• Child Behavior Problems

  3 months

• Parent Sleep Quality

  3 months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual Care

Sleep Coach Jr.

EXPERIMENTAL

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.

Interventions

Sleep Coach Jr. BEHAVIORAL

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.

Sleep Coach Jr.

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Randomized trial with 2 conditions (intervention and usual care).

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 11, 2018
• Study Start: July 5, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 9, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

US (1)