NCT02091648

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

March 4, 2014

Last Update Submit

January 4, 2016

Conditions

Asthma

Keywords

AsthmaStressChildrenPsychosocial FactorsRelaxationStress management

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (1)

  • Life Events Questionnaire

    Baseline

Study Arms (3)

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.

Behavioral: I Can Cope Intervention

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.

Behavioral: Standard Education Intervention

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.

Interventions

I Can Cope InterventionBEHAVIORAL

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.

I Can Cope Intervention
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.

Also known as: Open Airways for Schools Program
Standard Education Intervention

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (2)

  • 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.

    PMID: 21332379BACKGROUND

  • 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.

    PMID: 30657230DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anna L. Marsland, Ph.D., R.N.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology and Nursing

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 19, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

US(1)