AsthmaNCT02091648

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

A study testing I Can Cope Intervention and Standard Education Intervention in people with Asthma, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 14 years
Conditions the study is for: Asthma
What is being tested?: I Can Cope Intervention and Standard Education Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: A Pilot Stress Management Intervention for High Risk Children With Asthma

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.

Conditions: Asthma
Being tested: I Can Cope Intervention, Standard Education Intervention
Keywords: Asthma, Stress, Children, Psychosocial Factors, Relaxation, Stress management
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

I Can Cope InterventionBehavioural
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 InterventionBehavioural
Also called Open Airways for Schools Program
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.

Study groups in NCT02091648
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
Program Satisfaction Survey
Measured: End of Study Participation: up to 5 months from initial enrollment.
Barriers to offering the Intervention in Selected Schools
Measured: End of enrollment: estimated 2 years after beginning active enrollment.
Child Depression Inventory
Assess change in symptoms of depression.
Measured: Pre and Post Intervention: baseline, up to 4 months later.
State-Trait Anxiety Inventory for Children
Assess change in symptoms of anxiety and depression.
Measured: 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.
Measured: Pre and post intervention: baseline, up to 4 months later.
Pediatric Asthma Quality of Life Questionnaire
Assesses asthma-related quality of life.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre to post-intervention: baseline, up to 4 months later.

Secondary outcomes (1)

Life Events Questionnaire
Assesses life events that have had a negative impact on the child's psychological state.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Nov 2015

First posted19 Mar 2014 (estimated)
Study startJan 2013
Primary completionJul 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02091648
Sponsor's protocol ID: R34HL107613
Status last verified: Jan 2016
First submitted: 4 Mar 2014
Last updated: 5 Jan 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 21332379
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.
PubMed 30657230

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Stress Management Intervention for High Risk Children With Asthma
ClinicalTrials.gov ID: NCT02091648
Acronym / sponsor ID: R34HL107613
Conditions: Asthma
Keywords: Asthma, Stress, Children, Psychosocial Factors, Relaxation, Stress management
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Study start: Jan 2013
Primary completion: Jul 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 19 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
I Can Cope Intervention	Experimental	Behavioral: I Can Cope InterventionParticipants 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	Active comparator	Behavioral: Standard Education Interventionthis 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.
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.

Who may qualify

Ages: 8 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
I Can Cope InterventionParticipants 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.	Behavioural	I Can Cope Intervention
Standard Education InterventionAlso: Open Airways for Schools ProgramThis 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.	Behavioural	Standard Education Intervention

Primary outcome

Proportion of Eligible Children who Participate in Study
Time frame: End of enrollment: estimated 2 years after beginning active enrollment.
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.
Participant Drop-out Rates
Time frame: After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.
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.
Session Completion Rates
Time frame: After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.
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.
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
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
Assess change in symptoms of depression.
State-Trait Anxiety Inventory for Children
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
Assess change in symptoms of anxiety and depression.
Perceived Stress Scale
Time frame: Pre and post intervention: baseline, up to 4 months later.
Assess change in the degree to which the child perceives current demands as stressful and exceeding his or her ability to cope.
Pediatric Asthma Quality of Life Questionnaire
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
Assesses asthma-related quality of life.
Asthma Self-Management Scale
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
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).
KIDCOPE
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
Child participants will complete the Kidcope a 10-item measure of different coping strategies.
Measure of Current Status (MOCS - Adapted)
Time frame: Pre and Post Intervention: baseline, up to 4 months later.
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.
Change in Asthma Health from Baseline
Time frame: Pre to post-intervention: baseline, up to 4 months later.
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.

1 secondary outcome

Life Events Questionnaire
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Background: PubMed 21332379Long 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.
Derived from this study: PubMed 30657230Marsland 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna L. Marsland, Ph.D., R.N. principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing I Can Cope Intervention and Standard Education Intervention in people with Asthma, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eligible Children who Participate in Study (time frame: End of enrollment: estimated 2 years after beginning active enrollment.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02091648, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.