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Completed

NCT Number: NCT03144531

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

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

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Key information

Conditions

Sleep Disturbance Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mental Disorders Nervous System Diseases Parasomnias Respiratory Hypersensitivity Respiratory Tract Diseases Sleep Wake Disorders

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Intervention for Kids and Parents (SKIP)

Behavioral

Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve

Primary outcomes

  1. Total sleep time

    Time frame: 3 months post intervention (x 10 days of measurement)

    Actigraphy

  2. Sleep efficiency

    Time frame: 3 months post intervention (x 10 days of measurement)

    Actigraphy

  3. Bedtime Consistency

    Time frame: 3 months post intervention (x 10 days of measurement)

    Actigraphy

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: SKIP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 8, 2017
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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