Sleep Quality in High School Students With Asthma

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT03073187

Collaborator

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

Enrollment

Locations

11.8

Actual Duration (Months)

Patients Per Site

1.5

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 I only.

Condition or Disease	Intervention/Treatment	Phase
Asthma Sleep Asthma in Children

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).

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Apr 17, 2017

Actual Primary Completion Date :

Apr 10, 2018

Actual Study Completion Date :

Apr 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Students: Step 1 Interviews 20 adolescents with uncontrolled asthma and poor sleep [10 from New York City (NYC); 10 from Rhode Island (RI)] will provide information regarding their asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
Caregivers: Step 1 Interviews The caregivers of the 20 adolescents in this step [10 from NYC; 10 from RI] will be asked to provide information regarding their teenager's asthma and sleep routines, and on what they would like to see in an intervention targeting co-morbid asthma and poor sleep.
Teachers: Step 2 Interviews 4 high school teachers, 2 from NYC and 2 from RI, will review the developed intervention. They will provide their opinions about the appropriateness of the teaching methods and literacy level for adolescents.
Students: Step 3 Focus Groups 20 adolescents with uncontrolled asthma and poor sleep [10 from NYC; 10 from RI] will review the intervention providing feedback on its appropriateness and utility.
Caregivers: Step 3 Focus Groups The caregivers of the 20 adolescents in this step [10 from NYC; 10 from RI] will review the intervention providing feedback on its appropriateness and utility in small groups.

Outcome Measures

Primary Outcome Measures

Number of subjects successfully completing the interview [Up to 10 months]
Subjects will be interviewed regarding their preference and opinions about adapted curriculum.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

a prior asthma diagnosis in the prior 12 months;
use of prescribed asthma medications;
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
sleep duration < 8 hours

Exclusion Criteria:

report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
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.

SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)