NCT03073187|Completed
Sleep Quality in High School Students With Asthma
A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
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A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
Sponsor study identifier
Secondary identifiers
observational
36
1 country
2
Study Start
April 17, 2017
Actual (reported)Primary Completion
April 10, 2018
Actual (reported)Study Completion
April 10, 2018
Actual (reported)The overall goal of this project is to develop and to preliminarily validate a novel intervention to be delivered in the high school setting that integrates two evidence-based, school-based interventions for urban adolescents with proven efficacy: (1) Asthma Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and behaviors in urban adolescents. The aim for Phase I is to develop and integrate school-based interventions to improve asthma self-management and sleep hygiene in urban high school students via interviews. The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the intervention procedures; and (2) to assess the preliminary evidence of the effects of the intervention on improving sleep quality in urban high school students with persistent asthma over a 2-month follow-up period. This record is for Phase I only.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 10, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2017
Actual (reported)March 8, 2017
Actual (reported)April 17, 2017
Actual (reported)April 10, 2018
Actual (reported)April 10, 2018
Actual (reported)Number of subjects successfully completing the interview
Subjects will be interviewed regarding their preference and opinions about adapted curriculum.
Up to 10 months
20 adolescents with uncontrolled asthma and poor sleep \[10 from New York City (NYC); 10 from Rhode Island (RI)\] will provide information regarding their asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
The caregivers of the 20 adolescents in this step \[10 from NYC; 10 from RI\] will be asked to provide information regarding their teenager's asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
4 high school teachers, 2 from NYC and 2 from RI, will review the developed intervention. They will provide their opinions about the appropriateness of the teaching methods and literacy level for adolescents.
20 adolescents with uncontrolled asthma and poor sleep \[10 from NYC; 10 from RI\] will review the intervention providing feedback on its appropriateness and utility.
The caregivers of the 20 adolescents in this step \[10 from NYC; 10 from RI\] will review the intervention providing feedback on its appropriateness and utility in small groups.
Families for Steps 1 and 3 will be identified through schools, clinics, and non-profit agencies that focus on asthma (e.g., American Lung Association). School principals, clinic directors, administrators and/or clinicians will distribute a flyer to families advertising the study, and families will be asked to call the researchers. In Rhode Island, families will also be recruited from their lab's database of past referrals and past research participants. Interested families will be screened for study eligibility by trained study staff. Each site will recruit two high school teachers for Step 2 from teachers known to the investigative team (convenient sample)
Columbia University
New York, New York, 10032, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Koinis-Mitchell D, Kopel SJ, Boergers J, McQuaid EL, Esteban CA, Seifer R, Fritz GK, Beltran AJ, Klein RB, LeBourgeois M. Good Sleep Health in Urban Children With Asthma: A Risk and Resilience Approach. J Pediatr Psychol. 2015 Oct;40(9):888-903. doi: 10.1093/jpepsy/jsv046. Epub 2015 May 18.
Vignau J, Bailly D, Duhamel A, Vervaecke P, Beuscart R, Collinet C. Epidemiologic study of sleep quality and troubles in French secondary school adolescents. J Adolesc Health. 1997 Nov;21(5):343-50. doi: 10.1016/S1054-139X(97)00109-2.
Jean-Marie Bruzzese, PhD
Columbia University
Daphne Koinis-Mitchell, PhD
Rhode Island Hospital
36 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2017
First Posted
March 8, 2017
Study Start
April 17, 2017
Actual (reported)Rural Asthma Effectiveness Study
Contact the study team to confirm eligibility.
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Primary Completion
April 10, 2018
Actual (reported)Study Completion
April 10, 2018
Actual (reported)Last Updated
March 5, 2021
Record last verified: 2021-03
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