Clinical trial NCT03329066: Sleep Quality in High School Students With Asthma - II
Official title: A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: 2017-11-01
Enrollment: 63
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 II 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. 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. We developed a novel intervention -- Managing Asthma and Sleep in Teenagers (MAST) -- and in this phase of the study will evaluate the intervention's feasibility and acceptability and assess the preliminary evidence of intervention effects on improving sleep quality in urban high school students in NYC and Providence, RI. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).

The investigators hypothesize that: (1) The intervention will be feasible and acceptable as evidenced by adolescents' high rates of adherence to the treatment protocol, and their high satisfaction ratings and positive responses to exit interviews; and (2) relative to controls, over 2-months post-intervention adolescents randomized to the intervention will have significant improvement on the following outcomes assessing sleep quality: (1) sleep efficiency; (2) night awakenings; and (3) sleep duration. If hypotheses are supported, the investigators will explore whether treatment effects on sleep quality outcomes are mediated through changes in asthma self-management (e.g., confidence to care for asthma, steps taken to prevent the onset of symptoms, taking controller medication), and changes in sleep hygiene and behaviors (e.g., consistent bedtime and wake time, consistent sleep location, fewer sleep distractions in child's bedroom, decreased caffeine use). The investigators will also compare MAST to the evidence-based intervention -- Asthma Self-Management for Adolescents (ASMA) -- to explore if whether an asthma intervention integrated with sleep hygiene components enhances sleep quality above and beyond a behavioral, guideline-based asthma intervention.

To test how well MAST works, a pilot randomized controlled trial (RCT) with 84 urban adolescents (42 = NYC; 42 = RI) with persistent asthma and whose typical sleep duration is at/below what is recommended for this age group. Students will be recruited from high schools in New York City and in Greater Providence, RI, two areas of high asthma prevalence for urban adolescents. Students within schools will be randomized to one of three study arms: (1) MAST -- the new intervention consisting of both asthma and sleep hygiene components; (2) the original ASMA program; and (3) an informational and referral control group. The investigators will follow students for two months post-intervention and explore differences in feasibility, acceptability, and preliminary intervention effects by site.

Following consent, students and their parents/caregivers will complete baseline interviews, and will be randomized into one of the three study conditions. The investigators will deliver the intervention to the students at their respective schools, and will interview students and their parents/caregivers when the intervention ends and two months later. At each assessment, to assess sleep objectively, students will be asked to wear actigraph watches (Model AW2; Mini Mittler) for 2 weeks. During this two week period, they will also complete asthma and sleep logs where they record on a daily basis if they had asthma symptoms, took asthma medication, had asthma-related limitations, and information about their sleep; these logs are completed in the morning and the evening and should take less than 5 minutes each time to complete.

Eligibility criteria: Inclusion Criteria: Students will have

* (a) a prior asthma diagnosis;
* (b) used a prescribed asthma medication in the last 12 months; and
* (c) uncontrolled asthma, defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ ED visits or (iv) 1+ hospitalization for asthma; and (c) sleep duration 8.5 hours or less (at/below the appropriate number of hours of sleep for this age group through the following questions: What time do you: a) usually fall asleep on weekdays, b) usually wakeup on weekdays?).

Exclusion Criteria:

* report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
* 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.

Primary outcomes:
measure: Change in Sleep Quality score
timeFrame: Baseline, immediate post-intervention and 2-months post-intervention
Secondary outcomes:
measure: Change in Asthma Control score
timeFrame: Baseline, immediate post-intervention and 2-months post-intervention
measure: Change in Asthma Management Skill - Symptom Prevention Total Score
timeFrame: Baseline, immediate post-intervention and 2-months post-intervention
measure: Change in Asthma Management Skill - Symptom Prevention Steps
timeFrame: Baseline, immediate post-intervention and 2-months post-intervention
measure: Change in Asthma Management Skill - Attack Management score
timeFrame: Baseline, immediate post-intervention and 2-months post-intervention
measure: Change in Asthma Management Skill - Self-efficacy Score
timeFrame: Baseline, immediate post-intervention and 2-months post-intervention
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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