Sleep DisturbanceSKIPNCT03144531
Sleep Intervention for Kids and Parents: A Self-Management Pilot Study
A study testing Sleep Intervention for Kids and Parents (SKIP) in people with Sleep Disturbance and Asthma, run by University of Washington at 1 site in United States.
Trial summary
Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance and a parent with sleep disturbance. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Sleep Disturbance, Asthma
- What is being tested?
- Sleep Intervention for Kids and Parents (SKIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 8 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 18 years or older
- Able to understand and read English
Show all 10Show fewer
- 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
Who cannot join
- 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)
- Diagnosed obstructive sleep apnea or sleep disordered breathing
- Is a nightshift worker
- Uses sleep medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Nursing
Seattle, Washington, 98195
About this study
Official title: 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.
- Conditions
- Sleep Disturbance, Asthma
- Being tested
- Sleep Intervention for Kids and Parents (SKIP)
- Keywords
- School-age child
- Medical subject headings
- Parasomnias, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Intervention for Kids and Parents (SKIP)Behavioural
Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve
| Study group | Role | What they receive |
|---|---|---|
| SKIP Intervention | Experimental | Not described Receives: Behavioral: Sleep Intervention for Kids and Parents (SKIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Actigraphy
Measured: 3 months post intervention (x 10 days of measurement)
Sleep efficiency
Actigraphy
Measured: 3 months post intervention (x 10 days of measurement)
Bedtime Consistency
Actigraphy
Measured: 3 months post intervention (x 10 days of measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Mar 2017
- Primary completion30 Jul 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dyadic intervention for school-age children and a parent
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jennifer Sonney, University of Washington
- Investigators
- Jennifer Sonney, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144531
- Sponsor's protocol ID
- STUDY00001834
- Other IDs
- P30NR016585-01
- Acronym
- SKIP
- Status last verified
- Jul 2021
- First submitted
- 1 May 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32056537
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Intervention for Kids and Parents (SKIP): A Self-Management Pilot Study
- ClinicalTrials.gov ID
- NCT03144531
- Acronym / sponsor ID
- SKIP / STUDY00001834
- Conditions
- Sleep Disturbance, Asthma
- Keywords
- School-age child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance and a parent with sleep disturbance.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dyadic intervention for school-age children and a parent
| Arm | Type | Receives |
|---|---|---|
| SKIP Intervention | Experimental | Behavioral: Sleep Intervention for Kids and Parents (SKIP) |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
- 18 years or older
Key exclusion criteria (5 listed)
- 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)
- Diagnosed obstructive sleep apnea or sleep disordered breathing
- Is a nightshift worker
- Uses sleep medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Intervention for Kids and Parents (SKIP)Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve | Behavioural | SKIP Intervention |
Primary outcome
Total sleep time
Time frame: 3 months post intervention (x 10 days of measurement)
Actigraphy
Sleep efficiency
Time frame: 3 months post intervention (x 10 days of measurement)
Actigraphy
Bedtime Consistency
Time frame: 3 months post intervention (x 10 days of measurement)
Actigraphy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 32056537Sonney 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Sonney, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention for Kids and Parents (SKIP) in people with Sleep Disturbance and Asthma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (time frame: 3 months post intervention (x 10 days of measurement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.