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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Stress Management Intervention for High Risk Children With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: I Can Cope Intervention
* Behavioral: Standard Education Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I Can Cope Intervention<br>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. | Behavioral: I Can Cope Intervention<br>* 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.<br>|
| Active Comparator: Standard Education Intervention<br>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. | Behavioral: Standard Education Intervention<br>* 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.<br>* Other names: Open Airways for Schools Program;|
| No Intervention: No treatment control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eligible Children who Participate in Study | 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. | End of enrollment: estimated 2 years after beginning active enrollment. | 
| Participant Drop-out Rates | 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. | After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment. | 
| Session Completion Rates | 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. | After final participant has completed study: estimated 2 1/2 years after beginning active enrollement. | 
| Program Satisfaction Survey |  | End of Study Participation: up to 5 months from initial enrollment. | 
| Barriers to offering the Intervention in Selected Schools |  | End of enrollment: estimated 2 years after beginning active enrollment. | 
| Child Depression Inventory | Assess change in symptoms of depression. | Pre and Post Intervention: baseline, up to 4 months later. | 
| State-Trait Anxiety Inventory for Children | Assess change in symptoms of anxiety and depression. | Pre and Post Intervention: baseline, up to 4 months later. | 
| Perceived Stress Scale | Assess change in the degree to which the child perceives current demands as stressful and exceeding his or her ability to cope. | Pre and post intervention: baseline, up to 4 months later. | 
| Pediatric Asthma Quality of Life Questionnaire | Assesses asthma-related quality of life. | Pre and Post Intervention: baseline, up to 4 months later. | 
| Asthma Self-Management Scale | 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). | Pre and Post Intervention: baseline, up to 4 months later. | 
| KIDCOPE | Child participants will complete the Kidcope a 10-item measure of different coping strategies. | Pre and Post Intervention: baseline, up to 4 months later. | 
| Measure of Current Status (MOCS - Adapted) | 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. | Pre and Post Intervention: baseline, up to 4 months later. | 
| Change in Asthma Health from Baseline | 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. | Pre to post-intervention: baseline, up to 4 months later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Events Questionnaire | Assesses life events that have had a negative impact on the child's psychological state. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Stress, Children, Psychosocial Factors, Relaxation, Stress management