Sleep Quality in High School Students With Asthma - II
Condition: Asthma; Sleep; Asthma in Children
MeSH terms: Asthma
Study type: Interventional

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.
    

Intervention name(s): MAST - Managing Asthma & Sleep in Teens; ASMA - Asthma Self-Management for Adol; Information & Referral Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene.; This behavioral intervention focuses only on asthma care.; Students learn basic information about asthma and sleep, as well as other health topics relevant to teenagers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Sleep; Adolescents; Urban; Intervention; High school