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

N/ACompletedNCT02091648

University of Pittsburgh111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

111

Conditions

Asthma

Interventions

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 InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

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.