AsthmaNCT03329066
Sleep Quality in High School Students With Asthma - II
A study testing MAST - Managing Asthma & Sleep in Teens and ASMA - Asthma Self-Management for Adol in people with Asthma and Sleep, run by Columbia University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Asthma, Sleep, Asthma in Children
- What is being tested?
- MAST - Managing Asthma & Sleep in Teens and ASMA - Asthma Self-Management for Adol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2018to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (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?).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10032
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
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.
Read more
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.
Read the 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.
- Conditions
- Asthma, Sleep, Asthma in Children
- Being tested
- MAST - Managing Asthma & Sleep in Teens, ASMA - Asthma Self-Management for Adol, Information & Referral Control Group
- Keywords
- Asthma, Sleep, Adolescents, Urban, Intervention, High school
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAST - Managing Asthma & Sleep in TeensBehavioural
This behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene.
ASMA - Asthma Self-Management for AdolBehavioural
This behavioral intervention focuses only on asthma care.
Information & Referral Control GroupBehavioural
Students learn basic information about asthma and sleep, as well as other health topics relevant to teenagers.
| Study group | Role | What they receive |
|---|---|---|
| MAST - Managing Asthma & Sleep in Teens | Experimental | 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. Receives: Behavioral: MAST - Managing Asthma & Sleep in Teens |
| ASMA - Asthma Self-Management for Adol | Active comparator | 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. Receives: Behavioral: ASMA - Asthma Self-Management for Adol |
| Information & Referral Control Group | Placebo comparator | 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. Receives: Behavioral: Information & Referral Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Quality score
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.
Measured: Baseline, immediate post-intervention and 2-months post-intervention
Secondary outcomes (5)
Change in Asthma Control score
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.
Measured: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Symptom Prevention Total Score
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.
Measured: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Symptom Prevention Steps
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
Measured: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Attack Management score
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
Measured: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Self-efficacy Score
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.
Measured: Baseline, immediate post-intervention and 2-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start9 Apr 2018
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jean-Marie Bruzzese, Columbia University
- Investigators
- Jean-Marie Bruzzese, PhD, Principal investigator, Columbia UniversityDaphne Koinis-Mitchell, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329066
- Sponsor's protocol ID
- AAAQ9707 - II
- Other IDs
- 1R21HD086448-01A1
- Status last verified
- Mar 2021
- First submitted
- 27 Oct 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25991645Vignau J, Bailly D, Duhamel A, Vervaecke P, Beuscart R, Collinet C. Epidemiologic study of sleep quality and troubles in French secondary school adolescents. J Adolesc Health. 1997 Nov;21(5):343-50. doi: 10.1016/S1054-139X(97)00109-2.
PubMed 9358298Meltzer LJ, Ullrich M, Szefler SJ. Sleep duration, sleep hygiene, and insomnia in adolescents with asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):562-9. doi: 10.1016/j.jaip.2014.02.005. Epub 2014 Apr 13.
PubMed 25213049Wolfson AR, Carskadon MA. Understanding adolescents' sleep patterns and school performance: a critical appraisal. Sleep Med Rev. 2003 Dec;7(6):491-506. doi: 10.1016/s1087-0792(03)90003-7.
PubMed 15018092Wolfson AR, Carskadon MA. Sleep schedules and daytime functioning in adolescents. Child Dev. 1998 Aug;69(4):875-87.
PubMed 9768476Spilsbury JC, Storfer-Isser A, Drotar D, Rosen CL, Kirchner LH, Benham H, Redline S. Sleep behavior in an urban US sample of school-aged children. Arch Pediatr Adolesc Med. 2004 Oct;158(10):988-94. doi: 10.1001/archpedi.158.10.988.
PubMed 15466688Colrain IM, Baker FC. Changes in sleep as a function of adolescent development. Neuropsychol Rev. 2011 Mar;21(1):5-21. doi: 10.1007/s11065-010-9155-5. Epub 2011 Jan 12.
PubMed 21225346Dahl RE, Lewin DS. Pathways to adolescent health sleep regulation and behavior. J Adolesc Health. 2002 Dec;31(6 Suppl):175-84. doi: 10.1016/s1054-139x(02)00506-2.
PubMed 12470913Keyes KM, Maslowsky J, Hamilton A, Schulenberg J. The great sleep recession: changes in sleep duration among US adolescents, 1991-2012. Pediatrics. 2015 Mar;135(3):460-8. doi: 10.1542/peds.2014-2707.
PubMed 25687142Wong ML, Lau EY, Wan JH, Cheung SF, Hui CH, Mok DS. The interplay between sleep and mood in predicting academic functioning, physical health and psychological health: a longitudinal study. J Psychosom Res. 2013 Apr;74(4):271-7. doi: 10.1016/j.jpsychores.2012.08.014. Epub 2012 Sep 25.
PubMed 23497826Newacheck PW, Halfon N. Prevalence, impact, and trends in childhood disability due to asthma. Arch Pediatr Adolesc Med. 2000 Mar;154(3):287-93. doi: 10.1001/archpedi.154.3.287.
PubMed 10710030Worldwide variations in the prevalence of asthma symptoms: the International Study of Asthma and Allergies in Childhood (ISAAC). Eur Respir J. 1998 Aug;12(2):315-35. doi: 10.1183/09031936.98.12020315.
PubMed 9727780Centers for Disease Control and Prevention (CDC). Self-reported asthma among high school students--United States, 2003. MMWR Morb Mortal Wkly Rep. 2005 Aug 12;54(31):765-7.
PubMed 16094284Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
PubMed 19221156Pearce N, Ait-Khaled N, Beasley R, Mallol J, Keil U, Mitchell E, Robertson C; ISAAC Phase Three Study Group. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax. 2007 Sep;62(9):758-66. doi: 10.1136/thx.2006.070169. Epub 2007 May 15.
PubMed 17504817
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
- ClinicalTrials.gov ID
- NCT03329066
- Acronym / sponsor ID
- AAAQ9707 - II
- Conditions
- Asthma, Sleep, Asthma in Children
- Keywords
- Asthma, Sleep, Adolescents, Urban, Intervention, High school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAST - Managing Asthma & Sleep in Teens | Experimental | Behavioral: MAST - Managing Asthma & Sleep in TeensThis 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. |
| ASMA - Asthma Self-Management for Adol | Active comparator | Behavioral: ASMA - Asthma Self-Management for AdolASMA 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. |
| Information & Referral Control Group | Placebo comparator | Behavioral: Information & Referral Control GroupThe 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- (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?).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAST - Managing Asthma & Sleep in TeensThis behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene. | Behavioural | MAST - Managing Asthma & Sleep in Teens |
| ASMA - Asthma Self-Management for AdolThis behavioral intervention focuses only on asthma care. | Behavioural | ASMA - Asthma Self-Management for Adol |
| Information & Referral Control GroupStudents learn basic information about asthma and sleep, as well as other health topics relevant to teenagers. | Behavioural | Information & Referral Control Group |
Primary outcome
Change in Sleep Quality score
Time frame: 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.
5 secondary outcomes
Change in Asthma Control score
Time frame: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Symptom Prevention Total Score
Time frame: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Symptom Prevention Steps
Time frame: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Attack Management score
Time frame: Baseline, immediate post-intervention and 2-months post-intervention
Change in Asthma Management Skill - Self-efficacy Score
Time frame: Baseline, immediate post-intervention and 2-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Background: PubMed 25991645Koinis-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.
- Background: PubMed 9358298Vignau J, Bailly D, Duhamel A, Vervaecke P, Beuscart R, Collinet C. Epidemiologic study of sleep quality and troubles in French secondary school adolescents. J Adolesc Health. 1997 Nov;21(5):343-50. doi: 10.1016/S1054-139X(97)00109-2.
- Background: PubMed 25213049Meltzer LJ, Ullrich M, Szefler SJ. Sleep duration, sleep hygiene, and insomnia in adolescents with asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):562-9. doi: 10.1016/j.jaip.2014.02.005. Epub 2014 Apr 13.
- Background: PubMed 15018092Wolfson AR, Carskadon MA. Understanding adolescents' sleep patterns and school performance: a critical appraisal. Sleep Med Rev. 2003 Dec;7(6):491-506. doi: 10.1016/s1087-0792(03)90003-7.
- Background: PubMed 9768476Wolfson AR, Carskadon MA. Sleep schedules and daytime functioning in adolescents. Child Dev. 1998 Aug;69(4):875-87.
- Background: PubMed 15466688Spilsbury JC, Storfer-Isser A, Drotar D, Rosen CL, Kirchner LH, Benham H, Redline S. Sleep behavior in an urban US sample of school-aged children. Arch Pediatr Adolesc Med. 2004 Oct;158(10):988-94. doi: 10.1001/archpedi.158.10.988.
- Background: PubMed 21225346Colrain IM, Baker FC. Changes in sleep as a function of adolescent development. Neuropsychol Rev. 2011 Mar;21(1):5-21. doi: 10.1007/s11065-010-9155-5. Epub 2011 Jan 12.
- Background: PubMed 12470913Dahl RE, Lewin DS. Pathways to adolescent health sleep regulation and behavior. J Adolesc Health. 2002 Dec;31(6 Suppl):175-84. doi: 10.1016/s1054-139x(02)00506-2.
- Background: PubMed 25687142Keyes KM, Maslowsky J, Hamilton A, Schulenberg J. The great sleep recession: changes in sleep duration among US adolescents, 1991-2012. Pediatrics. 2015 Mar;135(3):460-8. doi: 10.1542/peds.2014-2707.
- Background: PubMed 23497826Wong ML, Lau EY, Wan JH, Cheung SF, Hui CH, Mok DS. The interplay between sleep and mood in predicting academic functioning, physical health and psychological health: a longitudinal study. J Psychosom Res. 2013 Apr;74(4):271-7. doi: 10.1016/j.jpsychores.2012.08.014. Epub 2012 Sep 25.
- Background: PubMed 10710030Newacheck PW, Halfon N. Prevalence, impact, and trends in childhood disability due to asthma. Arch Pediatr Adolesc Med. 2000 Mar;154(3):287-93. doi: 10.1001/archpedi.154.3.287.
- Background: PubMed 9727780Worldwide variations in the prevalence of asthma symptoms: the International Study of Asthma and Allergies in Childhood (ISAAC). Eur Respir J. 1998 Aug;12(2):315-35. doi: 10.1183/09031936.98.12020315.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Bruzzese, PhD principal investigator
Columbia University
Daphne Koinis-Mitchell, PhD principal investigator
Rhode Island Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAST - Managing Asthma & Sleep in Teens and ASMA - Asthma Self-Management for Adol in people with Asthma and Sleep, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality score (time frame: Baseline, immediate post-intervention and 2-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329066, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.