Clinical trial NCT03073187: Sleep Quality in High School Students With Asthma
Official title: A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Sleep
Asthma in Children
Keywords: Asthma
Sleep
Adolescents
Urban
Intervention
High school
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-03-08
Enrollment: 36
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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)

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.

Detailed description: Sleep quality among adolescents is poor and asthma's impact is significant among adolescents. Asthma control is an important risk factor for poor sleep and poor academic performance. In addition, poor asthma control, poor sleep hygiene, and poor sleep quality are more likely in urban settings. Interventions to promote sleep quality by targeting both asthma control and sleep hygiene in this vulnerable population are lacking.

To adapt ASMA and Sleep-Smart, the investigators will use a 3-step iterative process that will consist of (1) interviewing high school students and their caregivers, (2) interviewing high school teachers and (3) conducting separate focus groups with students and caregivers. The investigators hypothesize that the intervention will be feasible and acceptable. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).

Eligibility criteria: ADOLESCENT-CAREGIVER DYADS (20 adolescents with persistent asthma and poor sleep, and their caregivers - 10 in Step 1 and 10 in Step 3)

Inclusion Criteria:

1. a prior asthma diagnosis in the prior 12 months;
2. use of prescribed asthma medications;
3. 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
4. sleep duration \< 8 hours

Exclusion Criteria:

1. report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
2. A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
3. active immunotherapy;
4. additional pulmonary disease; and
5. 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)

Inclusion Criteria:

- Teach at the high school level.

Exclusion Criteria:

- Unwilling to participate in the study.

Primary outcomes:
measure: Number of subjects successfully completing the interview
timeFrame: Up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Columbia University
name: Jean-Marie Bruzzese, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Daphne Koinis-Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
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