Sleep Quality in High School Students With Asthma - II

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT03329066

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Locations

Arms

20.1

Actual Duration (Months)

31.5

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Sleep Asthma in Children	Behavioral: MAST - Managing Asthma & Sleep in Teens Behavioral: ASMA - Asthma Self-Management for Adol Behavioral: Information & Referral Control Group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The research assistants who interview the teenager and their parents/caregivers will not know to which arm the participants are randomized.

Primary Purpose:

Treatment

Official Title:

A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma

Actual Study Start Date :

Apr 9, 2018

Actual Primary Completion Date :

Dec 12, 2019

Actual Study Completion Date :

Dec 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAST - Managing Asthma & Sleep in Teens 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.	Behavioral: MAST - Managing Asthma & Sleep in Teens This behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene.
Active Comparator: ASMA - Asthma Self-Management for Adol 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.	Behavioral: ASMA - Asthma Self-Management for Adol This behavioral intervention focuses only on asthma care.
Placebo Comparator: Information & Referral Control Group 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.	Behavioral: Information & Referral Control Group Students learn basic information about asthma and sleep, as well as other health topics relevant to teenagers.

Arm

Intervention/Treatment

Experimental: MAST - Managing Asthma & Sleep in Teens

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.

Behavioral: MAST - Managing Asthma & Sleep in Teens

This behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene.

Active Comparator: ASMA - Asthma Self-Management for Adol

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.

Behavioral: ASMA - Asthma Self-Management for Adol

This behavioral intervention focuses only on asthma care.

Placebo Comparator: Information & Referral Control Group

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.

Behavioral: Information & Referral Control Group

Students learn basic information about asthma and sleep, as well as other health topics relevant to teenagers.

Outcome Measures

Primary Outcome Measures

Change in Sleep Quality score [Baseline, immediate post-intervention and 2-months post-intervention]
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.

Secondary Outcome Measures

Change in Asthma Control score [Baseline, immediate post-intervention and 2-months post-intervention]
We will use the Asthma Control Test, is a 5-item instrument validated for those 12 and older. Respondents indicate on a five-point scale how often in the past 4 weeks they had symptoms, had activity restrictions, used rescue medication; they also rate their perceived asthma control. Scores range from 5 to 25, with higher scores reflecting greater asthma control. An ACT score of 19 or more indicate well-controlled asthma.. Students will also report using a two-week recall of (a) # of days with symptoms, (b) # of nights woken wakening with symptoms, and (c) how bothered they were by the symptoms. We will also assess symptom severity using Whalgren's asthma symptom scale which rates asthma symptoms during the last 2 weeks on a 5 point scale where 0=none and 4=severe.
Change in Asthma Management Skill - Symptom Prevention Total Score [Baseline, immediate post-intervention and 2-months post-intervention]
We have adapted asthma self-management indices for adolescents developed and used in prior research by our team. These indices assess three categories of management behaviors: (1) symptom prevention; (2) attack management; and (3) self-efficacy in managing asthma. In our middle school study Cronbach's α was 0.67, 0.70, and 0.84 for symptom prevention, attack management, and asthma management self-efficacy, respectively, as reported by students. These scales are treatment sensitive (i.e., detect change in self-care following participation in an intervention). The symptom prevention scale can be used to calculate 2 scores, with one being the Symptom Prevention Total Score ranges from 0 - 27 with higher scores indicating that the teenager takes more steps to prevent symptoms, and does so more regularly.
Change in Asthma Management Skill - Symptom Prevention Steps [Baseline, immediate post-intervention and 2-months post-intervention]
We have adapted asthma self-management indices for adolescents developed and used in prior research by our team. These indices assess three categories of management behaviors: (1) symptom prevention; (2) attack management; and (3) self-efficacy in managing asthma. In our middle school study Cronbach's α was 0.67, 0.70, and 0.84 for symptom prevention, attack management, and asthma management self-efficacy, respectively, as reported by students. These scales are treatment sensitive (i.e., detect change in self-care following participation in an intervention). The symptom prevention scale can be used to calculate 2 scores, with one being the Symptom Prevention Steps ranges from 0 - 9 with higher scores indicating that the teenager takes more steps to prevent the onset of symptoms
Change in Asthma Management Skill - Attack Management score [Baseline, immediate post-intervention and 2-months post-intervention]
We have adapted asthma self-management indices for adolescents developed and used in prior research by our team. These indices assess three categories of management behaviors: (1) symptom prevention; (2) attack management; and (3) self-efficacy in managing asthma. In our middle school study Cronbach's α was 0.67, 0.70, and 0.84 for symptom prevention, attack management, and asthma management self-efficacy, respectively, as reported by students. These scales are treatment sensitive (i.e., detect change in self-care following participation in an intervention). The Attack Management Score ranges from 0 - 7 with higher scores indicating more steps taken to manage existing symptoms
Change in Asthma Management Skill - Self-efficacy Score [Baseline, immediate post-intervention and 2-months post-intervention]
We have adapted asthma self-management indices for adolescents developed and used in prior research by our team. These indices assess three categories of management behaviors: (1) symptom prevention; (2) attack management; and (3) self-efficacy in managing asthma. In our middle school study Cronbach's α was 0.67, 0.70, and 0.84 for symptom prevention, attack management, and asthma management self-efficacy, respectively, as reported by students. These scales are treatment sensitive (i.e., detect change in self-care following participation in an intervention). For the self-efficacy score, the mean of 14 items is calculated with scores ranging from 1 to 6 with higher scores indicated more self-efficacy to care for asthma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.