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

Primary Purpose

Sleep Disturbance, Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Intervention for Kids and Parents (SKIP)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Disturbance focused on measuring School-age child

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington School of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SKIP Intervention

Arm Description

Outcomes

Primary Outcome Measures

Total sleep time
Actigraphy
Sleep efficiency
Actigraphy
Bedtime Consistency
Actigraphy

Secondary Outcome Measures

Full Information

First Posted
May 1, 2017
Last Updated
July 28, 2021
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03144531
Brief Title
Sleep Intervention for Kids and Parents: A Self-Management Pilot Study
Acronym
SKIP
Official Title
Sleep Intervention for Kids and Parents (SKIP): A Self-Management Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Asthma
Keywords
School-age child

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Dyadic intervention for school-age children and a parent
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKIP Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Sleep Intervention for Kids and Parents (SKIP)
Intervention Description
Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve
Primary Outcome Measure Information:
Title
Total sleep time
Description
Actigraphy
Time Frame
3 months post intervention (x 10 days of measurement)
Title
Sleep efficiency
Description
Actigraphy
Time Frame
3 months post intervention (x 10 days of measurement)
Title
Bedtime Consistency
Description
Actigraphy
Time Frame
3 months post intervention (x 10 days of measurement)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Sonney, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Nursing
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32056537
Citation
Sonney JT, Thompson HJ, Landis CA, Pike KC, Chen ML, Garrison MM, Ward TM. Sleep intervention for children with asthma and their parents (SKIP Study): a novel web-based shared management pilot study. J Clin Sleep Med. 2020 Jun 15;16(6):925-936. doi: 10.5664/jcsm.8374.
Results Reference
derived

Learn more about this trial

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

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