Clinical trial NCT02091648: A Pilot Stress Management Intervention Study for High Risk Children With Asthma
Official title: A Pilot Stress Management Intervention for High Risk Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Stress
Children
Psychosocial Factors
Relaxation
Stress management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 111
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Eligible Children who Participate in Study
timeFrame: End of enrollment: estimated 2 years after beginning active enrollment.
measure: Participant Drop-out Rates
timeFrame: After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.
measure: Session Completion Rates
timeFrame: After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
measure: Program Satisfaction Survey
timeFrame: End of Study Participation: up to 5 months from initial enrollment.
measure: Barriers to offering the Intervention in Selected Schools
timeFrame: End of enrollment: estimated 2 years after beginning active enrollment.
measure: Child Depression Inventory
timeFrame: Pre and Post Intervention: baseline, up to 4 months later.
measure: State-Trait Anxiety Inventory for Children
timeFrame: Pre and Post Intervention: baseline, up to 4 months later.
measure: Perceived Stress Scale
timeFrame: Pre and post intervention: baseline, up to 4 months later.
measure: Pediatric Asthma Quality of Life Questionnaire
timeFrame: Pre and Post Intervention: baseline, up to 4 months later.
measure: Asthma Self-Management Scale
timeFrame: Pre and Post Intervention: baseline, up to 4 months later.
measure: KIDCOPE
timeFrame: Pre and Post Intervention: baseline, up to 4 months later.
measure: Measure of Current Status (MOCS - Adapted)
timeFrame: Pre and Post Intervention: baseline, up to 4 months later.
measure: Change in Asthma Health from Baseline
timeFrame: Pre to post-intervention: baseline, up to 4 months later.
Secondary outcomes:
measure: Life Events Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anna L. Marsland, Ph.D., R.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.