Sleep Intervention for Kids and Parents: A Self-Management Pilot Study

Asthma Clinical Trial

— SKIP  

Official title:

Sleep Intervention for Kids and Parents (SKIP): A Self-Management Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144531
• Other study ID #: STUDY00001834
• Secondary ID: P30NR016585-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 8, 2018

Study information

• Verified date: July 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance and a parent with sleep disturbance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 8, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria (child):

• Children 6-11 years

• Child diagnosis of asthma with prescription for daily medication

• Able to understand English (child)

• Sleep disturbance per CSHQ (child >= 41) and/or < 9 hours of sleep per night

Exclusion Criteria (child)

• Parent reported diagnosis of traumatic brain injury, developmental delay, autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), obstructive sleep apnea, cancer

• Positive sleep related breathing disorder screening (obstructive sleep apnea screening)

Inclusion Criteria (parent)

• 18 years or older

• Able to understand and read English

• Lives with child 50% of time or more

• Is child's legal guardian

• Has reliable access to internet

• >/= 5 on Pittsburgh Sleep Quality Index or <7 hours overnight reported sleep

Exclusion Criteria (parent)

• Diagnosed obstructive sleep apnea or sleep disordered breathing

• Is a nightshift worker

• Uses sleep medication

Related Conditions & MeSH terms

• Asthma
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Sleep Intervention for Kids and Parents (SKIP)
Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve

Locations

Country	Name	City	State
United States	University of Washington School of Nursing	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time	Actigraphy	3 months post intervention (x 10 days of measurement)
Primary	Sleep efficiency	Actigraphy	3 months post intervention (x 10 days of measurement)
Primary	Bedtime Consistency	Actigraphy	3 months post intervention (x 10 days of measurement)