Sleep Quality in High School Students With Asthma - II

NCT03329066 | Completed

• 2 other identifiers: AAAQ9707 - II1R21HD086448-01A1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Sleep; Asthma in Children

Keywords

Asthma; Sleep; Adolescents; Urban; Intervention; High school

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, immediate post-intervention and 2-months post-intervention

Secondary Outcomes (5)

• Change in Asthma Control score

  Baseline, immediate post-intervention and 2-months post-intervention

• Change in Asthma Management Skill - Symptom Prevention Total Score

  Baseline, immediate post-intervention and 2-months post-intervention

• Change in Asthma Management Skill - Symptom Prevention Steps

  Baseline, immediate post-intervention and 2-months post-intervention

• Change in Asthma Management Skill - Attack Management score

  Baseline, immediate post-intervention and 2-months post-intervention

• Change in Asthma Management Skill - Self-efficacy Score

  Baseline, immediate post-intervention and 2-months post-intervention

Study Arms (3)

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.

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.

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.

Behavioral: Information & Referral Control Group

Interventions

MAST - Managing Asthma & Sleep in Teens BEHAVIORAL

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

MAST - Managing Asthma & Sleep in Teens

ASMA - Asthma Self-Management for Adol BEHAVIORAL

This behavioral intervention focuses only on asthma care.

ASMA - Asthma Self-Management for Adol

Information & Referral Control Group BEHAVIORAL

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

Information & Referral Control Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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?).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (31)

• 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.

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• Koinis-Mitchell D, McQuaid EL, Kopel SJ, Esteban CA, Ortega AN, Seifer R, Garcia-Coll C, Klein R, Cespedes E, Canino G, Fritz GK. Cultural-related, contextual, and asthma-specific risks associated with asthma morbidity in urban children. J Clin Psychol Med Settings. 2010 Mar;17(1):38-48. doi: 10.1007/s10880-009-9178-3.

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• Koinis-Mitchell D, Kopel SJ, Boergers J, Ramos K, LeBourgeois M, McQuaid EL, Esteban CA, Seifer R, Fritz GK, Klein R. Asthma, allergic rhinitis, and sleep problems in urban children. J Clin Sleep Med. 2015 Jan 15;11(2):101-10. doi: 10.5664/jcsm.4450.

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MeSH Terms

Conditions

Asthma

Interventions

Sleep

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean-Marie Bruzzese, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Daphne Koinis-Mitchell, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants who interview the teenager and their parents/caregivers will not know to which arm the participants are randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Applied Developmental Psychology (in Nursing)

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 1, 2017
• Study Start: April 9, 2018
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)