An interventional study of I Can Cope Intervention and Standard Education Intervention in Asthma, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2016-01-05.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 111 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
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.
Also known as: Open Airways for Schools Program
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.
Time frame: 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.
Time frame: 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.
Time frame: After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
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
Assess change in symptoms of depression.
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
State-Trait Anxiety Inventory for Children
Assess change in symptoms of anxiety and depression.
Time frame: 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.
Time frame: Pre and post intervention: baseline, up to 4 months later.
Pediatric Asthma Quality of Life Questionnaire
Assesses asthma-related quality of life.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre to post-intervention: baseline, up to 4 months later.
Life Events Questionnaire
Assesses life events that have had a negative impact on the child's psychological state.
Time frame: Baseline
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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