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

Vanderbilt University Medical Center

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Sleep Coach Jr.

Study type: Interventional

Funder types: Other

Identifiers

NCT03397147

171902

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Usual Care

Sleep Coach Jr.

Experimental group

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.

Treatment:

Behavioral: Sleep Coach Jr.