NCT03144531

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

May 1, 2017

Last Update Submit

July 28, 2021

Conditions

Keywords

School-age child

Outcome Measures

Primary Outcomes (3)

  • Total sleep time

    Actigraphy

    3 months post intervention (x 10 days of measurement)

  • Sleep efficiency

    Actigraphy

    3 months post intervention (x 10 days of measurement)

  • Bedtime Consistency

    Actigraphy

    3 months post intervention (x 10 days of measurement)

Study Arms (1)

SKIP Intervention

EXPERIMENTAL
Behavioral: Sleep Intervention for Kids and Parents (SKIP)

Interventions

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

SKIP Intervention

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • Diagnosed obstructive sleep apnea or sleep disordered breathing
  • Is a nightshift worker
  • Uses sleep medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ParasomniasAsthma

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jennifer Sonney, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Dyadic intervention for school-age children and a parent
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Family and Child Nursing

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 8, 2017

Study Start

March 1, 2017

Primary Completion

July 30, 2018

Study Completion

August 8, 2018

Last Updated

August 4, 2021

Record last verified: 2021-07

Locations