A Pilot Stress Management Intervention for High Risk Children With Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- University of Pittsburgh
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Proportion of Eligible Children who Participate in Study
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Anna L. Marsland
Associate Professor of Psychology and Nursing
University of Pittsburgh
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
Outcomes
Primary Outcomes
Proportion of Eligible Children who Participate in Study
Time Frame: End of enrollment: estimated 2 years after beginning active enrollment.
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.
Participant Drop-out Rates
Time Frame: After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.
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.
Session Completion Rates
Time Frame: After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
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.
Program Satisfaction Survey
Time Frame: End of Study Participation: up to 5 months from initial enrollment.
Barriers to offering the Intervention in Selected Schools
Time Frame: End of enrollment: estimated 2 years after beginning active enrollment.
Child Depression Inventory
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
Assess change in symptoms of depression.
State-Trait Anxiety Inventory for Children
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
Assess change in symptoms of anxiety and depression.
Perceived Stress Scale
Time Frame: Pre and post intervention: baseline, up to 4 months later.
Assess change in the degree to which the child perceives current demands as stressful and exceeding his or her ability to cope.
Pediatric Asthma Quality of Life Questionnaire
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
Assesses asthma-related quality of life.
Asthma Self-Management Scale
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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).
KIDCOPE
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
Child participants will complete the Kidcope a 10-item measure of different coping strategies.
Measure of Current Status (MOCS - Adapted)
Time Frame: Pre and Post Intervention: baseline, up to 4 months later.
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.
Change in Asthma Health from Baseline
Time Frame: Pre to post-intervention: baseline, up to 4 months later.
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.
Secondary Outcomes
- Life Events Questionnaire(Baseline)