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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I Can Cope Intervention | Experimental | 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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| Standard Education Intervention | Active Comparator | 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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| No treatment control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I Can Cope Intervention | Behavioral | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Life Events Questionnaire | Assesses life events that have had a negative impact on the child's psychological state. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna L. Marsland, Ph.D., R.N. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21332379 | Background | 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. | |
| 30657230 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Standard Education Intervention | Behavioral | 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. |
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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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |