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

July 28, 2021 updated by: Jennifer Sonney, University of Washington

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Nursing

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

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SKIP Intervention
Behavioral: Sleep Intervention for Kids and Parents (SKIP)
Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep time
Time Frame: 3 months post intervention (x 10 days of measurement)
Actigraphy
3 months post intervention (x 10 days of measurement)
Sleep efficiency
Time Frame: 3 months post intervention (x 10 days of measurement)
Actigraphy
3 months post intervention (x 10 days of measurement)
Bedtime Consistency
Time Frame: 3 months post intervention (x 10 days of measurement)
Actigraphy
3 months post intervention (x 10 days of measurement)

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Jennifer Sonney, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2017

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

August 8, 2018

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (ACTUAL)

May 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001834
  • P30NR016585-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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