A Pilot Stress Management Intervention Study for High Risk Children With Asthma

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02091648

Run by

University of Pittsburgh

People needed

111

Starts

2013-01-01

Expected to finish

2015-11-01

Last updated by the study team

2016-01-05

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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