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

Asthma Clinical Trial

Official title:

A Pilot Stress Management Intervention for High Risk Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091648
• Other study ID #: R34HL107613
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: January 4, 2016
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• I Can Cope Intervention
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.
• Standard Education Intervention
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	Program Satisfaction Survey		End of Study Participation: up to 5 months from initial enrollment.	No
Primary	Barriers to offering the Intervention in Selected Schools		End of enrollment: estimated 2 years after beginning active enrollment.	No
Primary	Child Depression Inventory	Assess change in symptoms of depression.	Pre and Post Intervention: baseline, up to 4 months later.	Yes
Primary	State-Trait Anxiety Inventory for Children	Assess change in symptoms of anxiety and depression.	Pre and Post Intervention: baseline, up to 4 months later.	No
Primary	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.	No
Primary	Pediatric Asthma Quality of Life Questionnaire	Assesses asthma-related quality of life.	Pre and Post Intervention: baseline, up to 4 months later.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	Life Events Questionnaire	Assesses life events that have had a negative impact on the child's psychological state.	Baseline	No