NCT03329066|Completed
Sleep Quality in High School Students With Asthma - II
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
interventional
63
1 country
2
Study Start
April 9, 2018
Actual (reported)Primary Completion
December 12, 2019
Actual (reported)Study Completion
December 12, 2019
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 II only.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2017
Actual (reported)November 1, 2017
Actual (reported)April 9, 2018
Actual (reported)December 12, 2019
Actual (reported)December 12, 2019
Actual (reported)Change in Sleep Quality score
Sleep efficiency will be calculated from data obtain from actigraphs (Model AW2; Mini Mittler) that the teenagers will wear for 2 weeks at each point.
Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Control score
Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Symptom Prevention Total Score
Baseline, immediate post-intervention and 2-months post-intervention
This is an eight week intervention consisting of 4 group and 4 individual tailored coaching sessions that focuses on both asthma and sleep. In this behavioral medicine intervention, teenagers learn ways to better care for their asthma and sleep hygiene. Teen sessions are delivered in school. Their caregivers will receive four educational booklets that correspond to each group session; topics mirror the objectives of each group and the booklets are sent at the time of each group.
ASMA is an evidence-based intervention for students, caregiver education, and education for students' medical providers. The student intervention consists of 3 group sessions \& 5 individual tailored coaching sessions. All sessions are held at school. The caregiver intervention includes 3 educational booklets that correspond to the timing of the student group and 4 brief telephone-counseling sessions to review the booklets, answer questions, and provide strategies to support adolescents' steps to care for their asthma. With caregiver permission, we mail students' healthcare providers a toolkit consisting of (1) a letter informing them their patient is participating in ASMA and is being directed to them for clinical evaluation and (2) summaries of key NHLBI guidelines for treating asthma.
This behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene.
This behavioral intervention focuses only on asthma care.
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
63 participants (actual enrollment reported by the registry).
First Submitted
October 27, 2017
First Posted
November 1, 2017
Study Start
April 9, 2018
Asthma Implementation Research Trial
Change in Asthma Management Skill - Symptom Prevention Steps
Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Attack Management score
Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Self-efficacy Score
Baseline, immediate post-intervention and 2-months post-intervention
The information-and-referral control intervention is a student-only intervention that consists of 3 group sessions and 5 individual sessions. Sessions are held once a week at school, where students will receive guideline-based information about asthma and other health topics relevant to adolescents (e.g., nutrition, safety). Students will be referred to their medical providers for asthma and other health concerns; if they do not have a provider, they are given referrals in their community.
Students learn basic information about asthma and sleep, as well as other health topics relevant to teenagers.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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Bruzzese JM, Stepney C, Fiorino EK, Bornstein L, Wang J, Petkova E, Evans D. Asthma self-management is sub-optimal in urban Hispanic and African American/black early adolescents with uncontrolled persistent asthma. J Asthma. 2012 Feb;49(1):90-7. doi: 10.3109/02770903.2011.637595. Epub 2011 Dec 7.
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Koinis-Mitchell D, McQuaid EL, Seifer R, Kopel SJ, Esteban C, Canino G, Garcia-Coll C, Klein R, Fritz GK. Multiple urban and asthma-related risks and their association with asthma morbidity in children. J Pediatr Psychol. 2007 Jun;32(5):582-95. doi: 10.1093/jpepsy/jsl050. Epub 2007 Jan 11.
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Williams DR, Sternthal M, Wright RJ. Social determinants: taking the social context of asthma seriously. Pediatrics. 2009 Mar;123 Suppl 3(Suppl 3):S174-84. doi: 10.1542/peds.2008-2233H.
Clark NM, Brown R, Joseph CL, Anderson EW, Liu M, Valerio M, Gong M. Issues in identifying asthma and estimating prevalence in an urban school population. J Clin Epidemiol. 2002 Sep;55(9):870-81. doi: 10.1016/s0895-4356(02)00451-1.
Koinis-Mitchell D, McQuaid EL, Kopel SJ, Esteban CA, Ortega AN, Seifer R, Garcia-Coll C, Klein R, Cespedes E, Canino G, Fritz GK. Cultural-related, contextual, and asthma-specific risks associated with asthma morbidity in urban children. J Clin Psychol Med Settings. 2010 Mar;17(1):38-48. doi: 10.1007/s10880-009-9178-3.
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Spilsbury JC, Storfer-Isser A, Kirchner HL, Nelson L, Rosen CL, Drotar D, Redline S. Neighborhood disadvantage as a risk factor for pediatric obstructive sleep apnea. J Pediatr. 2006 Sep;149(3):342-7. doi: 10.1016/j.jpeds.2006.04.061.
Boergers J, Koinis-Mitchell D. Sleep and culture in children with medical conditions. J Pediatr Psychol. 2010 Oct;35(9):915-26. doi: 10.1093/jpepsy/jsq016. Epub 2010 Mar 23.
Koinis-Mitchell D, Kopel SJ, Boergers J, Ramos K, LeBourgeois M, McQuaid EL, Esteban CA, Seifer R, Fritz GK, Klein R. Asthma, allergic rhinitis, and sleep problems in urban children. J Clin Sleep Med. 2015 Jan 15;11(2):101-10. doi: 10.5664/jcsm.4450.
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Primary Completion
December 12, 2019
Actual (reported)Study Completion
December 12, 2019
Actual (reported)Last Updated
March 4, 2021
Record last verified: 2021-03
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