- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091648
A Pilot Stress Management Intervention Study for High Risk Children With Asthma
January 4, 2016 updated by: Anna L. Marsland, University of Pittsburgh
A Pilot Stress Management Intervention for High Risk Children With Asthma
The purpose of the proposed study is to conduct a randomized controlled pilot trial of a school-based stress management and coping skills training program among a sample of economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed asthma.
The investigators aim (1) to establish feasibility of this approach by recruiting from different schools and (2) to learn whether individuals assigned to receive the intervention show improvements in psychological function, decreases in lung inflammation, and related improvements in asthma health when compared with disease severity-matched peers who receive education-only or standard care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- In grades 3 through 8 and attending one of the 11 participating public schools
- Age 8 through 14 years
- Qualify for the free or reduced cost school lunch program in Pennsylvania (families that receive food stamps or have an annual income of < $40,900).
- Meets National Heart Lung and Blood Institute (NHLBI, 2007) criteria for any asthma diagnosis EXCEPT mild, intermittent asthma, as confirmed by the study physician using NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf, page 40).
- Has a parent or legal guardian who is willing to participate in the study
- Fluent in English (i.e., have commonly used English in everyday speaking and reading for at least 10 years)
Exclusion Criteria:
- History of a chronic illness in addition to asthma (determined by parent or guardian report)
- Prescribed medications other than for asthma
- Mental retardation or significant developmental delay
- Inability to speak or understand English
- A diagnosis of mild, intermittent asthma as determined using NHLBI (2007) criteria (see above)
- Age less then 8 years or greater than 14 years
- Not in grades 3 through 8
- Not qualifying for free or reduced cost school lunches in Pennsylvania
- No parent or legal guardian who is willing to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I Can Cope Intervention
Participants randomized to the "I Can Cope" condition will receive 6 face-to-face individualized sessions over a 2-month period.
Each session will last 50 minutes and take place at the child's school either during approved times during the school day or as part of the after-school program.
Sessions are psychoeducational and experiential and include opportunities for the child with asthma to: (1) learn about the pathophysiology of asthma; (2) understand the biological impact of stress on the body; (3) learn the relationship among thoughts, feelings, actions, and asthma; (4) acquire a set of coping skills to help deal with asthma-related and day-to-day stressors in their lives, and (5) receive training in biofeedback-assisted relaxation techniques.
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Participants randomized to the "I Can Cope" condition will receive 6 face-to-face individualized sessions over a 2-month period.
Each session will last 50 minutes and take place at the child's school either during approved times during the school day or as part of the after-school program.
Sessions are psychoeducational and experiential and include opportunities for the child with asthma to: (1) learn about the pathophysiology of asthma; (2) understand the biological impact of stress on the body; (3) learn the relationship among thoughts, feelings, actions, and asthma; (4) acquire a set of coping skills to help deal with asthma-related and day-to-day stressors in their lives, and (5) receive training in biofeedback-assisted relaxation techniques.
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Active Comparator: Standard Education Intervention
this group will receive the standard American Lung Association "Open Airways for Schools" program.
This program includes six 40-minute sessions covering the National Heart Lung and Blood Institute recommendations for asthma education.
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This group will receive the standard American Lung Association (ALA)"Open Airways for Schools" program.
This program includes six 40-minute sessions covering the National Heart Lung and Blood Institute's recommendations for asthma education.
Other Names:
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No Intervention: No treatment control
This group will receive no treatment during the course of the study and will have the option to receive the "Open Airways" program after their participation in the study is complete.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Eligible Children who Participate in Study
Time Frame: End of enrollment: estimated 2 years after beginning active enrollment.
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A measure of the feasibility of offering the "I Can Cope" intervention trial to socioeconomically disadvantaged 8-14 year-old children with physician-confirmed asthma in urban schools.
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End of enrollment: estimated 2 years after beginning active enrollment.
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Participant Drop-out Rates
Time Frame: After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.
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A measure of the feasibility of offering the "I Can Cope" intervention trial to socioeconomically disadvantaged 8-14 year-old children with physician-confirmed asthma in urban schools.
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After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.
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Session Completion Rates
Time Frame: After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
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A measure of the feasibility of offering the "I Can Cope" intervention trial to socioeconomically disadvantaged 8-14 year-old children with physician-confirmed asthma in urban schools.
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After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
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Program Satisfaction Survey
Time Frame: End of Study Participation: up to 5 months from initial enrollment.
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End of Study Participation: up to 5 months from initial enrollment.
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Barriers to offering the Intervention in Selected Schools
Time Frame: End of enrollment: estimated 2 years after beginning active enrollment.
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End of enrollment: estimated 2 years after beginning active enrollment.
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Child Depression Inventory
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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Assess change in symptoms of depression.
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Pre and Post Intervention: baseline, up to 4 months later.
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State-Trait Anxiety Inventory for Children
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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Assess change in symptoms of anxiety and depression.
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Pre and Post Intervention: baseline, up to 4 months later.
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Perceived Stress Scale
Time Frame: Pre and post intervention: baseline, up to 4 months later.
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Assess change in the degree to which the child perceives current demands as stressful and exceeding his or her ability to cope.
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Pre and post intervention: baseline, up to 4 months later.
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Pediatric Asthma Quality of Life Questionnaire
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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Assesses asthma-related quality of life.
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Pre and Post Intervention: baseline, up to 4 months later.
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Asthma Self-Management Scale
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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Parent and child participants will complete the which assesses beliefs that they can perform behaviors to alleviate the child's asthma, including behaviors associated with symptom prevention (e.g., getting to doctor, using medication, and avoiding allergens) as well as symptom management (e.g., staying calm, controlling symptoms, deciding how to manage symptoms).
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Pre and Post Intervention: baseline, up to 4 months later.
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KIDCOPE
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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Child participants will complete the Kidcope a 10-item measure of different coping strategies.
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Pre and Post Intervention: baseline, up to 4 months later.
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Measure of Current Status (MOCS - Adapted)
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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In order to measure the effectiveness of stress management training, child participants will complete an adapted version of the 10-item Measure of Current Status assessing perceived self-efficacy for skills targeted by the intervention: the ability to relax, to recognize stress-inducing situations, to be assertive about needs, and to choose appropriate coping responses.
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Pre and Post Intervention: baseline, up to 4 months later.
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Change in Asthma Health from Baseline
Time Frame: Pre to post-intervention: baseline, up to 4 months later.
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The magnitude of intervention-related improvements in the child's asthma health will be measured by change in pulmonary function, exhaled levels of nitric oxide, and symptoms of asthma, as well as number of medical visits, and school absenteeism.
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Pre to post-intervention: baseline, up to 4 months later.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life Events Questionnaire
Time Frame: Baseline
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Assesses life events that have had a negative impact on the child's psychological state.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna L. Marsland, Ph.D., R.N., University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Long KA, Ewing LJ, Cohen S, Skoner D, Gentile D, Koehrsen J, Howe C, Thompson AL, Rosen RK, Ganley M, Marsland AL. Preliminary evidence for the feasibility of a stress management intervention for 7- to 12-year-olds with asthma. J Asthma. 2011 Mar;48(2):162-70. doi: 10.3109/02770903.2011.554941.
- Marsland AL, Gentile D, Hinze-Crout A, von Stauffenberg C, Rosen RK, Tavares A, Votruba-Drzal E, Cohen S, McQuaid EL, Ewing LJ. A randomized pilot trial of a school-based psychoeducational intervention for children with asthma. Clin Exp Allergy. 2019 May;49(5):591-602. doi: 10.1111/cea.13337. Epub 2019 Feb 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 17, 2014
First Posted (Estimate)
March 19, 2014
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34HL107613 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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