Childhood AsthmaNCT03481673
COPE for Children With Asthma: Intervention for Children With Asthma
A study testing COPE for Asthma in people with Childhood Asthma and Childhood Anxiety Disorder, run by Ohio State University at 1 site in United States.
Trial summary
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Asthma, Childhood Anxiety Disorder, Childhood Depression
- What is being tested?
- COPE for Asthma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2017to 21 May 2018
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age 8-12 years enrolled in Columbus City Schools
- Diagnosis of persistent asthma requiring daily inhaled controller medication use at some point (medical condition form on file with the school/CG report)
- Have symptoms depression or anxiety per the PROMIS/SCARED measures
- Have written consent to participate provided by care giver and child assent
- The participating care giver has primary or at least equal responsibility for the day-to-day management of the child's asthma
- care givers provide written consent for their own participation
- Be able to speak, read, and write in English (care giver and child).
Who cannot join
- has other significant pulmonary conditions (e.g., pulmonary fibrosis, cystic fibrosis)
- currently receiving treatment from a mental health professional
- child or CG has cognitive learning disability that could interfere with the ability to comprehend the interview questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COPE for Children With Asthma: A Cognitive Behavior Skills-Building
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. The purpose of this study is to evaluate the effects of a manualized cognitive behavior skills-building intervention on key physical and mental health outcomes in 8 to 12-year old children with persistent asthma and co-morbid anxiety and/or depression. The results of this study will inform a large scale randomized controlled trial to fully test this needed intervention.
COPE (Creating Opportunities for Personal Empowerment), developed by Dr. Melnyk, is a manualized intervention that has been implemented with children, adolescents, and young adults. COPE is a cognitive behavior skills-building program based on cognitive behavior theory. Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings, youth with obesity, and teens experiencing chronic recurrent headaches. However, the COPE program has never been adapted and tested with children who have persistent asthma. This study proposes to test an adaptation of this evidence-based program, "COPE for Asthma," with 8 to 12-year-old children with persistent asthma and elevated anxiety and/or depressive symptoms. COPE for Asthma combines components of asthma education with cognitive behavioral skills. This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population.
Read the detailed description
The Interventionist was trained on the implementation of the COPE intervention and will deliver the COPE for Asthma intervention. The intervention, delivered by Colleen McGovern -the Interventionist, will take place in a room within the school separate from other students. The room will include a door for privacy. The intervention will be once/week, 30 minute sessions, for 7 weeks - during lunch and/or recess time. Groups during lunch and recess, or "lunch bunch" groups, are routinely held in the school system by the social workers, guidance counselors, and school nurses. Participants will be given weekly tickets allowing them to get in line first to pick up their lunch to maximize the allotted time. If the material for a session is not covered (i.e., school-wide fire drill, lock down, or other unforeseen event), the session will be moved to the following week.
In the event a participant has severely elevated t-scores, >=70, on the anxiety or depression screening tools or expresses feelings or intent to harm self or others (at any time point or otherwise), the principal, school nurse and/or guidance counselor/social worker will be notified for follow-up per the school district's protocol. A form letter will be sent to the child's CG that day. If child discloses accounts of abuse or neglect, Franklin County Children's Services will be notified and the principal, school nurse and/or guidance counselor/social worker.
Consent/assent of the CG and child and initial screening for anxiety/depression:SCARED and PROMIS measures; will be completed by the Interventionist and a research assistant, RA, from Dr. Melnyk's research team. Data collection and the intervention will start when >=5 child/CG dyads have been consented/assented in a school.
Week 1 at baseline. To avoid bias, the Interventionist will serve as the interventionist and the RA will complete the data gathering. The measures for the child participants will be explained, then self-administered, and checked for completeness by the RA. The RA will conduct phone interviews with the CGs to gather data on demographics, controller medication adherence, and the Asthma Control Test. If phone contact is not possible, the surveys will be sent home with the child with sealable envelopes for the return.
Weeks 2 - 8. COPE for Asthma will be delivered in small groups (Interventionist may need to implement the intervention at several schools on different days; this is expected). Lessons include 30 minutes of didactic teaching and activities.
Post-Intervention Assessment, after the 7-week intervention. After the last COPE for Asthma session has been implemented in a group, a member of Dr. Melnyk's research team will administer the post-intervention follow-up surveys. CGs will be contacted to complete the parent/CG survey.
6-Week Post-Intervention Assessment. The same procedure as for the post-intervention assessment will be conducted for this time period for the children and CGs.
- Being tested
- COPE for Asthma
- Keywords
- Childhood Asthma, Childhood Anxiety, Childhood Depression, Childhood Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPE for AsthmaBehavioural
The intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This pre-experimental pilot project is a single group, pretest-posttest design with a 6-week post-intervention follow-up. A single group design was chosen for this feasibility pilot study because the COPE for Asthma intervention is newly adapted for 8 to 12-year-old children with asthma in an urban setting. The intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression. Surveys with children and their parents/caregivers (CGs) will occur at baseline, immediately post-intervention and 6 weeks' post-intervention. Receives: Behavioral: COPE for Asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in perception of asthma self-management over three time points
Asthma Management Self-Efficacy: The Child ASE scale (14 items) measures children's perception of their own ability to manage asthma (e.g., "...can tell when a serious breathing problem can be controlled at home"); assesses asthma symptoms, health status, and impact of the child's illness on the family. Higher scores indicate greater self-efficacy; (α=.87). This measure has been validated in children ages 7 - 15 years.
Measured: Baseline (week 1, before the intervention starts), post-intervention (week 8-9, after the 7-week intervention), and 6-weeks post-intervention (week 16-17).
Secondary outcomes (8)
Measure change in anxiety symptoms over three time points
Anxiety Symptoms: SCARED (Screen for Child Anxiety Related Emotional Disorders) assesses five factors including panic/somatic, general anxiety disorder, separation anxiety, social phobia, and school phobia; it has been validated with children and adolescents ages 8 - 19 years. Items are scored from 0 (not true or hardly ever true) to 2 (very true or often true). Higher scores indicate greater anxiety with a total score of 25 as having a potential anxiety disorder and 30 as more specific (α=.70 - .90).
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in depressive symptoms over three time points
Depressive Symptoms: PROMIS Pediatric Short Form: Assesses negative mood (e.g., sadness), decrease in positive affect (e.g., loss of interest), negative views of self (e.g., worthlessness), and negative social cognition (e.g., loneliness, interpersonal alienation). Items are scored from 0 (never) to 4 (almost always). Higher scores indicate greater anxiety(α=.85). The PROMIS Pediatric Instruments are intended for children between the ages of 8 - 17 years.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in confidence in managing stress over three time points
Personal Beliefs Scale: Child Version: 10-item Likert-type scale with items scored from 1 (strongly disagree) to 5 (strongly agree); assesses personal beliefs and confidence about managing stress. Higher scores indicate greater beliefs (α=.85). This scale has been used in prior studies for children and youth between the ages of 9 - 18 years.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in symptom interpretation over three time points
Symptom Interpretation: Childhood Asthma Symptom Checklist (CASCL): Interpretation of symptoms; 20-item measure of the frequency that children experience physical symptoms, irritability, and panic-fear during asthma attacks.191 Items are scored on a 4-point scale from 1 (never) to 4 (always). In addition to the three subscales the instrument yields a total symptom score (α=.81). This measure has been validated for children between the ages of 6 - 18 years.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in barriers to controller medications over three time points
Asthma Illness Representation Scale (AIRS-C): Child Version: The 17-item AIRS Child (AIRS-C) was designed to identify barriers and risk factors for under-utilization of controller medications. Higher scores indicate closer alignment with the professional model for asthma management. This scale has been adapted from the validated parent version and was tested in a small pilot study with acceptable reliability(α=.84). It has been validated for children between the ages of 6 - 17 years.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in quality of life over three time points
Pediatric Asthma Quality of Life Questionnaire (PAQLQ): 14-item Likert-type scale validated for children between ages 7 - 17 years; measures the functional problems (symptoms, activity limitations, emotional function) that are troublesome to children with asthma.31 Items are scored from 1 (extremely bothered) to 7 (not bothered at all) and the total score is the mean of items. Higher scores denote better QoL.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in asthma control over three time points
Asthma control: The Childhood Asthma Control Test (C-ACT) consists of questions for children (ages 4-11 years; 4 items) and parents (3 items) and the ACT (for individuals 12 years and older) has similar questions which are self-administered. This instruments assesses interference with activities, asthma symptoms, and nighttime awakenings. The C-ACT (α=.79) exhibits good reliability and validity, and classifies children as very poorly controlled, not well-controlled, or well controlled.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure comprehension over each lesson
Education Manipulation Checks: 4 (ordinal) questions will be asked after each session to evaluate children's comprehension of session content. Answering 3 out of 4 questions correctly indicates understanding. The Interventionist will review the incorrect questions and provide re-education for that item. These questions are age appropriate questions in line with the manual.
Measured: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start15 Jul 2017
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, pre-experimental, intervention pilot study.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Nurses Foundation, Sigma Theta Tau International Honor Society of Nursing, National Association of Pediatric Nurse Practitioners, Sigma Theta Tau Epsilon Branch
- Responsible party
- Sponsor
- Investigators
- Colleen McGovern, PhD(c), Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481673
- Sponsor's protocol ID
- 2017B0094
- Status last verified
- Aug 2018
- First submitted
- 20 Nov 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.
PubMed 267128602. Centers for Disease Control and Prevention. Healthy Schools; asthma and schools. 2015. Retrieved on 3-28-2016 from http://www.cdc.gov/healthyschools/asthma/index.htm
3. American Lung Association. Asthma and Children Fact Sheet. Retrieved on 4-1-2016 from http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/asthma/learn-about-asthma/asthma-children-facts-sheet.html
Goodwin RD, Hottinger K, Pena L, Chacko A, Feldman J, Wamboldt MZ, Hoven C. Asthma and mental health among youth in high-risk service settings. J Asthma. 2014 Aug;51(6):639-44. doi: 10.3109/02770903.2014.897728. Epub 2014 Mar 18.
PubMed 24628526Lu Y, Mak KK, van Bever HP, Ng TP, Mak A, Ho RC. Prevalence of anxiety and depressive symptoms in adolescents with asthma: a meta-analysis and meta-regression. Pediatr Allergy Immunol. 2012 Dec;23(8):707-15. doi: 10.1111/pai.12000. Epub 2012 Sep 9.
PubMed 22957535Strunk RC, Mrazek DA, Fuhrmann GS, LaBrecque JF. Physiologic and psychological characteristics associated with deaths due to asthma in childhood. A case-controlled study. JAMA. 1985 Sep 6;254(9):1193-8.
PubMed 4021061Feldman JM, Ortega AN, McQuaid EL, Canino G. Comorbidity between asthma attacks and internalizing disorders among Puerto Rican children at one-year follow-up. Psychosomatics. 2006 Jul-Aug;47(4):333-9. doi: 10.1176/appi.psy.47.4.333.
PubMed 16844893Goodwin RD, Robinson M, Sly PD, McKeague IW, Susser ES, Zubrick SR, Stanley FJ, Mattes E. Severity and persistence of asthma and mental health: a birth cohort study. Psychol Med. 2013 Jun;43(6):1313-22. doi: 10.1017/S0033291712001754. Epub 2012 Aug 29.
PubMed 23171853Feldman JM, Siddique MI, Morales E, Kaminski B, Lu SE, Lehrer PM. Psychiatric disorders and asthma outcomes among high-risk inner-city patients. Psychosom Med. 2005 Nov-Dec;67(6):989-96. doi: 10.1097/01.psy.0000188556.97979.13.
PubMed 16314605Al Aloola NA, Naik-Panvelkar P, Nissen L, Saini B. Asthma interventions in primary schools--a review. J Asthma. 2014 Oct;51(8):779-98. doi: 10.3109/02770903.2014.914534. Epub 2014 May 19.
PubMed 24730772Yorke J, Fleming SL, Shuldham C. A systematic review of psychological interventions for children with asthma. Pediatr Pulmonol. 2007 Feb;42(2):114-24. doi: 10.1002/ppul.20464.
PubMed 17186533Ritz T, Meuret AE, Trueba AF, Fritzsche A, von Leupoldt A. Psychosocial factors and behavioral medicine interventions in asthma. J Consult Clin Psychol. 2013 Apr;81(2):231-50. doi: 10.1037/a0030187. Epub 2012 Oct 1.
PubMed 23025250Shanahan L, Copeland WE, Worthman CM, Angold A, Costello EJ. Children with both asthma and depression are at risk for heightened inflammation. J Pediatr. 2013 Nov;163(5):1443-7. doi: 10.1016/j.jpeds.2013.06.046. Epub 2013 Aug 3.
PubMed 23919906Goodwin RD, Bandiera FC, Steinberg D, Ortega AN, Feldman JM. Asthma and mental health among youth: etiology, current knowledge and future directions. Expert Rev Respir Med. 2012 Aug;6(4):397-406. doi: 10.1586/ers.12.34.
PubMed 22971065Feldman JM, Kutner H, Matte L, Lupkin M, Steinberg D, Sidora-Arcoleo K, Serebrisky D, Warman K. Prediction of peak flow values followed by feedback improves perception of lung function and adherence to inhaled corticosteroids in children with asthma. Thorax. 2012 Dec;67(12):1040-5. doi: 10.1136/thoraxjnl-2012-201789.
PubMed 23154987
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE for Children With Asthma: A Cognitive Behavior Skills-Building
- ClinicalTrials.gov ID
- NCT03481673
- Acronym / sponsor ID
- 2017B0094
- Keywords
- Childhood Asthma, Childhood Anxiety, Childhood Depression, Childhood Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Nurses Foundation, Sigma Theta Tau International Honor Society of Nursing, National Association of Pediatric Nurse Practitioners, Sigma Theta Tau Epsilon Branch
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. The purpose of this study is to evaluate the effects of a manualized cognitive behavior skills-building intervention on key physical and mental health outcomes in 8 to 12-year old children with persistent asthma and co-morbid anxiety and/or depression. The results of this study will inform a large scale randomized controlled trial to fully test this needed intervention.
COPE (Creating Opportunities for Personal Empowerment), developed by Dr. Melnyk, is a manualized intervention that has been implemented with children, adolescents, and young adults. COPE is a cognitive behavior skills-building program based on cognitive behavior theory. Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings, youth with obesity, and teens experiencing chronic recurrent headaches. However, the COPE program has never been adapted and tested with children who have persistent asthma. This study proposes to test an adaptation of this evidence-based program, "COPE for Asthma," with 8 to 12-year-old children with persistent asthma and elevated anxiety and/or depressive symptoms. COPE for Asthma combines components of asthma education with cognitive behavioral skills. This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population.
Detailed description
The Interventionist was trained on the implementation of the COPE intervention and will deliver the COPE for Asthma intervention. The intervention, delivered by Colleen McGovern -the Interventionist, will take place in a room within the school separate from other students. The room will include a door for privacy. The intervention will be once/week, 30 minute sessions, for 7 weeks - during lunch and/or recess time. Groups during lunch and recess, or "lunch bunch" groups, are routinely held in the school system by the social workers, guidance counselors, and school nurses. Participants will be given weekly tickets allowing them to get in line first to pick up their lunch to maximize the allotted time. If the material for a session is not covered (i.e., school-wide fire drill, lock down, or other unforeseen event), the session will be moved to the following week.
In the event a participant has severely elevated t-scores, >=70, on the anxiety or depression screening tools or expresses feelings or intent to harm self or others (at any time point or otherwise), the principal, school nurse and/or guidance counselor/social worker will be notified for follow-up per the school district's protocol. A form letter will be sent to the child's CG that day. If child discloses accounts of abuse or neglect, Franklin County Children's Services will be notified and the principal, school nurse and/or guidance counselor/social worker.
Consent/assent of the CG and child and initial screening for anxiety/depression:SCARED and PROMIS measures; will be completed by the Interventionist and a research assistant, RA, from Dr. Melnyk's research team. Data collection and the intervention will start when >=5 child/CG dyads have been consented/assented in a school.
Week 1 at baseline. To avoid bias, the Interventionist will serve as the interventionist and the RA will complete the data gathering. The measures for the child participants will be explained, then self-administered, and checked for completeness by the RA. The RA will conduct phone interviews with the CGs to gather data on demographics, controller medication adherence, and the Asthma Control Test. If phone contact is not possible, the surveys will be sent home with the child with sealable envelopes for the return.
Weeks 2 - 8. COPE for Asthma will be delivered in small groups (Interventionist may need to implement the intervention at several schools on different days; this is expected). Lessons include 30 minutes of didactic teaching and activities.
Post-Intervention Assessment, after the 7-week intervention. After the last COPE for Asthma session has been implemented in a group, a member of Dr. Melnyk's research team will administer the post-intervention follow-up surveys. CGs will be contacted to complete the parent/CG survey.
6-Week Post-Intervention Assessment. The same procedure as for the post-intervention assessment will be conducted for this time period for the children and CGs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, pre-experimental, intervention pilot study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: COPE for AsthmaThis pre-experimental pilot project is a single group, pretest-posttest design with a 6-week post-intervention follow-up. A single group design was chosen for this feasibility pilot study because the COPE for Asthma intervention is newly adapted for 8 to 12-year-old children with asthma in an urban setting. The intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression. Surveys with children and their parents/caregivers (CGs) will occur at baseline, immediately post-intervention and 6 weeks' post-intervention. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children age 8-12 years enrolled in Columbus City Schools
- Diagnosis of persistent asthma requiring daily inhaled controller medication use at some point (medical condition form on file with the school/CG report)
- Have symptoms depression or anxiety per the PROMIS/SCARED measures
- Have written consent to participate provided by care giver and child assent
- The participating care giver has primary or at least equal responsibility for the day-to-day management of the child's asthma
Key exclusion criteria (3 listed)
- has other significant pulmonary conditions (e.g., pulmonary fibrosis, cystic fibrosis)
- currently receiving treatment from a mental health professional
- child or CG has cognitive learning disability that could interfere with the ability to comprehend the interview questions.
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 |
|---|---|---|
| COPE for AsthmaThe intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression. | Behavioural | Intervention |
Primary outcome
Measure change in perception of asthma self-management over three time points
Time frame: Baseline (week 1, before the intervention starts), post-intervention (week 8-9, after the 7-week intervention), and 6-weeks post-intervention (week 16-17).
Asthma Management Self-Efficacy: The Child ASE scale (14 items) measures children's perception of their own ability to manage asthma (e.g., "...can tell when a serious breathing problem can be controlled at home"); assesses asthma symptoms, health status, and impact of the child's illness on the family. Higher scores indicate greater self-efficacy; (α=.87). This measure has been validated in children ages 7 - 15 years.
8 secondary outcomes
Measure change in anxiety symptoms over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in depressive symptoms over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in confidence in managing stress over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in symptom interpretation over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in barriers to controller medications over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in quality of life over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure change in asthma control over three time points
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
Measure comprehension over each lesson
Time frame: Baseline (before the intervention starts), post-intervention (after the 7-week intervention), and 6-weeks post-intervention.
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 21 Aug 2018.
- Background: PubMed 26712860Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.
- Background2. Centers for Disease Control and Prevention. Healthy Schools; asthma and schools. 2015. Retrieved on 3-28-2016 from http://www.cdc.gov/healthyschools/asthma/index.htm
- Background3. American Lung Association. Asthma and Children Fact Sheet. Retrieved on 4-1-2016 from http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/asthma/learn-about-asthma/asthma-children-facts-sheet.html
- Background: PubMed 24628526Goodwin RD, Hottinger K, Pena L, Chacko A, Feldman J, Wamboldt MZ, Hoven C. Asthma and mental health among youth in high-risk service settings. J Asthma. 2014 Aug;51(6):639-44. doi: 10.3109/02770903.2014.897728. Epub 2014 Mar 18.
- Background: PubMed 22957535Lu Y, Mak KK, van Bever HP, Ng TP, Mak A, Ho RC. Prevalence of anxiety and depressive symptoms in adolescents with asthma: a meta-analysis and meta-regression. Pediatr Allergy Immunol. 2012 Dec;23(8):707-15. doi: 10.1111/pai.12000. Epub 2012 Sep 9.
- Background: PubMed 4021061Strunk RC, Mrazek DA, Fuhrmann GS, LaBrecque JF. Physiologic and psychological characteristics associated with deaths due to asthma in childhood. A case-controlled study. JAMA. 1985 Sep 6;254(9):1193-8.
- Background: PubMed 16844893Feldman JM, Ortega AN, McQuaid EL, Canino G. Comorbidity between asthma attacks and internalizing disorders among Puerto Rican children at one-year follow-up. Psychosomatics. 2006 Jul-Aug;47(4):333-9. doi: 10.1176/appi.psy.47.4.333.
- Background: PubMed 23171853Goodwin RD, Robinson M, Sly PD, McKeague IW, Susser ES, Zubrick SR, Stanley FJ, Mattes E. Severity and persistence of asthma and mental health: a birth cohort study. Psychol Med. 2013 Jun;43(6):1313-22. doi: 10.1017/S0033291712001754. Epub 2012 Aug 29.
- Background: PubMed 16314605Feldman JM, Siddique MI, Morales E, Kaminski B, Lu SE, Lehrer PM. Psychiatric disorders and asthma outcomes among high-risk inner-city patients. Psychosom Med. 2005 Nov-Dec;67(6):989-96. doi: 10.1097/01.psy.0000188556.97979.13.
- Background: PubMed 24730772Al Aloola NA, Naik-Panvelkar P, Nissen L, Saini B. Asthma interventions in primary schools--a review. J Asthma. 2014 Oct;51(8):779-98. doi: 10.3109/02770903.2014.914534. Epub 2014 May 19.
- Background: PubMed 17186533Yorke J, Fleming SL, Shuldham C. A systematic review of psychological interventions for children with asthma. Pediatr Pulmonol. 2007 Feb;42(2):114-24. doi: 10.1002/ppul.20464.
- Background: PubMed 23025250Ritz T, Meuret AE, Trueba AF, Fritzsche A, von Leupoldt A. Psychosocial factors and behavioral medicine interventions in asthma. J Consult Clin Psychol. 2013 Apr;81(2):231-50. doi: 10.1037/a0030187. Epub 2012 Oct 1.
- Individual participant dataSharing planned: No
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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.
Colleen McGovern, PhD(c) principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPE for Asthma in people with Childhood Asthma and Childhood Anxiety Disorder, run by Ohio State University 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 7 inclusion and 3 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 21 Aug 2018. 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?
Measure change in perception of asthma self-management over three time points (time frame: Baseline (week 1, before the intervention starts), post-intervention (week 8-9, after the 7-week intervention), and 6-weeks post-intervention (week 16-17).). 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 NCT03481673, which also lists 42 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 21 Aug 2018.