Sleep Quality in High School Students With Asthma

NCT03073187 | Completed

• 2 other identifiers: AAAQ9707 - I1R21HD086448-01A1
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma; Sleep; Asthma in Children

Keywords

Asthma; Sleep; Adolescents; Urban; Intervention; High school

Outcome Measures

Primary Outcomes (1)

• Number of subjects successfully completing the interview

  Subjects will be interviewed regarding their preference and opinions about adapted curriculum.

  Up to 10 months

Study Arms (5)

Students: Step 1 Interviews

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.

Caregivers: Step 1 Interviews

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.

Teachers: Step 2 Interviews

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.

Students: Step 3 Focus Groups

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.

Caregivers: Step 3 Focus Groups

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.

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• a prior asthma diagnosis in the prior 12 months;
• use of prescribed asthma medications;
• persistent asthma (defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ Emergency Department visits or (iv) 1+ hospitalization for asthma); and
• sleep duration \< 8 hours

You may not qualify if:

• report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
• A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
• active immunotherapy;
• additional pulmonary disease; and
• significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses.
• SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)
• \- Teach at the high school level.
• \- Unwilling to participate in the study.

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (33)

• 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.

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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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• 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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• 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.

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• 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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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jean-Marie Bruzzese, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Daphne Koinis-Mitchell, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Developmental Psychology (in Nursing)

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 8, 2017
• Study Start: April 17, 2017
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)