Childhood AsthmaNCT04089085
STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression
A study testing STRONGer Together in people with Childhood Asthma and Childhood Anxiety, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Childhood Asthma, Childhood Anxiety, Childhood Depression
- What is being tested?
- STRONGer Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Dec 2022
- 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
- No healthy volunteers
- Child
Who may be able to join
- In the range of 8 - 12 years of age,
- Child has a diagnosis of asthma or reactive airway and prescribed a controller medication or have intermittent symptoms,
- Child has at least slightly elevated anxiety or depressive symptoms upon screening at enrollment,
- The parent/caregiver can understand and answer the survey questions in English; child can understand English in a small group setting and can answer survey questions in English,
- The consenting parent/caregiver has at least equal responsibility for the day-to-day management of the child's asthma.
Who cannot join
- Child has other pulmonary conditions (e.g., cystic fibrosis/pulmonary fibrosis),
- Child or parent/caregiver cannot answer the survey questions due to a cognitive delay.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms.
Read the detailed description
Asthma is one of the leading chronic conditions in children and affects 6.1 million children in the United States. 5,15,16 It is one of the most common causes of school absenteeism and is a major public health issue, accounting for over $56 billion dollars annually in healthcare costs. 16 Children with asthma have increased odds ~ 3.13 of having co-morbid anxiety/depression, a lower quality of life, and higher morbidity and mortality rates. 4,17-21 In recent years, the economic burden of asthma 22 and the level of impairment due to mental health concerns have increased for children and adolescents. 23 A study by Secinti, Thompson, Richards, and Gaysina (2017) highlights the association between childhood chronic physical conditions and adult emotional health, further emphasizing the critical need to address physical health as well as the emotional and mental health of children with asthma. 24 More distally, asthma, anxiety, and depression cause inflammation. 25 Left unaddressed, adults with asthma and comorbid anxiety/depression may be at higher risk of cardiovascular disease. 25,26 Compounding potential health related complications of asthma and comorbid anxiety/depressive symptoms is the disproportionate effect of asthma for children from ethnic and racial minority populations 4,19 or from socioeconomically disadvantaged settings. 19 Further, underserved populations are less likely to receive appropriate medical or mental health care for a variety of reasons such as transportation, neighborhood factors, a caregiver's inability to pay for needed medications or treatment, and healthcare provider bias. 20 Cost-related barriers were found to be most indicative of uncontrolled asthma in a recent study. 27 Clinicians, policy makers, and researchers must be responsive and provide interventions to ameliorate detrimental outcomes. Prior studies indicate that not only are children with asthma and anxiety/depression less likely to adhere to treatment guidelines, they are prone to misinterpretation of their symptoms leading to overuse of their quick-relief inhaler. 20 Symptoms of anxiety and asthma are often confused and psychological factors can be a trigger for an asthma attack. 25 Improvement in symptom interpretation, asthma self-efficacy, and asthma illness beliefs has been associated with better asthma control. 28 Children using skills to take care of their asthma, or asthma self-management, is a dynamic process. Self-efficacy contributes to one's to self-management behaviors. 29 While many factors contribute to managing one's asthma, the skills can be easily learned. However, children with asthma are frequently expected to manage their medications at a very young age and may not have the knowledge or skills yet to understand what actions to take and when. For example, a study by Orrell-Valente, Jarlsberg, Hill, and Cabana (2008) found that 20% of children aged 7 years were responsible for managing their asthma medications, and by age 11 years, 50% of children are left to manage their asthma medications without caregiver assistance. 30 Bellin and colleagues (2017) interviewed children as young as six years of age that self-administered their medication. 31 Because of this, educating children about asthma is imperative so they can more accurately interpret their symptoms and treat themselves for optimal health, particularly since it is a lifelong condition. The proposed one group pilot will determine the feasibility and acceptability of an 8-session educational and skills-building intervention in YMCA after-school programs in Orange and Chatham counties, and one school in Durham county in North Carolina.
- Conditions
- Childhood Asthma, Childhood Anxiety, Childhood Depression
- Being tested
- STRONGer Together
- Keywords
- Childhood Asthma, Childhood Anxiety/depression, Educational and Behavioral Intervention for Children
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRONGer TogetherBehavioural
STRONGer (Successes/Strengths, Triggers, Remember your medications, Ongoing communication, Never give up!, Gratitude) Together is an asthma educational and cognitive behavioral skills intervention for children between 8 - 12 years of age. The intervention is implemented in small groups in 30-minute sessions.
| Study group | Role | What they receive |
|---|---|---|
| One group pilot | Other | The experimental group will receive the intervention, which is an 8-week (30 minute session per week) asthma educational and cognitive behavioral skills program. Receives: Behavioral: STRONGer Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
Feasibility will be established if 80% of the participants attend 6 out of 8 sessions.
Measured: 8-weeks
Acceptability related to the Intervention
Acceptability will be established if 80% of the child participants practice the skills or practice sheets.
Measured: 8 weeks
Acceptability of the Intervention - for the Child Participants
Questions relate to satisfaction with the program and general like/dislike (rated 0 - 5; higher score reflects more satisfaction) and qualitative questions about what participants liked or would change about the program.
Measured: 8 weeks
Acceptability of the Intervention - for the Parent/Caregiver Participants
Questions relate to overall satisfaction with the program (0 - 5; higher score reflects greater satisfaction) and qualitative questions about if/what their child learned from the program.
Measured: 8 weeks
Secondary outcomes (8)
Asthma Management Self-Efficacy - Child
The Child Asthma Self-Efficacy (CASE) 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") and assesses asthma symptoms, health status, and impact of the child's illness on the family (Bursch, Schwankovsky, Gilbert, \& Zeiger, 1999). Answers are scored 1 - 5; higher scores indicate greater self-efficacy.
Measured: From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.
Anxiety Measure (Screen for Child Anxiety Related Disorders [SCARED]) - Child
The SCARED measure 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 (Beidas et al., 2015; Hale, Crocetti, Raaijmakers, \& Meeus, 2011; Birmaher et al., 1999). Items are scored from 0 (not true or hardly ever true) to 2 (very true or often true; Birmaher et al., 1999). Higher scores indicate greater anxiety with a total score of 25 as having a potential anxiety disorder and 30 as more specific.
Measured: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Depression Measure (Patient-Reported Outcomes Measurement Information System [PROMIS]- Child Depression Short Form)
The PROMIS Child Depression 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; Assessment Center, n.d.). Items are scored from 0 (never) to 4 (almost always). Higher scores indicate greater depressive symptoms.
Measured: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Asthma Illness Representations - Child Version (AIRS-C)
The AIRS-C is a 17-item measure designed to identify barriers to and risk factors for under-utilization of controller medications. Higher scores indicate closer alignment with the professional model of asthma management.
Measured: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) - Child
The PAQLQ 14-item Likert-type scale is validated for children between ages 7 - 17 years (Juniper, Guyatt, Ferrie, \& Griffith, 1993) and measures the functional problems (symptoms, activity limitations, emotional function) that are troublesome to children with asthma (Juniper et al., 1993). 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: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Peak Flow - Child
The child participants will be asked to complete peak flow assessments (blowing into the meter) during the study to evaluate lung function. A higher number indicates better lung function.
Measured: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Pediatric Symptom Checklist - completed by the Parent/Caregiver
The PSC includes 17 Likert type questions to assess internalizing, attention, and externalizing problems (Murphy et al., 2016). Items are scored from 0 (never) to 2 (often; α = .89). Examples of questions include "My child feels sad, unhappy" and "Daydreams too much." Higher scores indicate more symptoms.
Measured: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Asthma Control Test - Combined Child and Parent/Caregiver
The 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 instrument assesses interference with activities, asthma symptoms, and nighttime awakenings. The C-ACT (α = .79; Lui et al., 2007; Lui et al., 2010) classifies children as very poorly controlled, not well-controlled, or well controlled.
Measured: From baseline to 8 weeks (immediately post-intervention) and 16 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 posted13 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One Group Pilot Study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International
- Responsible party
- Principal investigator, Colleen McGovern, University of North Carolina, Greensboro
- Investigators
- Colleen McGovern, PhD, Principal investigator, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089085
- Sponsor's protocol ID
- 19-1290
- Status last verified
- Nov 2022
- First submitted
- 9 Sep 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression
- ClinicalTrials.gov ID
- NCT04089085
- Acronym / sponsor ID
- 19-1290
- Conditions
- Childhood Asthma, Childhood Anxiety, Childhood Depression
- Keywords
- Childhood Asthma, Childhood Anxiety/depression, Educational and Behavioral Intervention for Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Sep 2019 (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.
The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms.
Detailed description
Asthma is one of the leading chronic conditions in children and affects 6.1 million children in the United States. 5,15,16 It is one of the most common causes of school absenteeism and is a major public health issue, accounting for over $56 billion dollars annually in healthcare costs. 16 Children with asthma have increased odds ~ 3.13 of having co-morbid anxiety/depression, a lower quality of life, and higher morbidity and mortality rates. 4,17-21 In recent years, the economic burden of asthma 22 and the level of impairment due to mental health concerns have increased for children and adolescents. 23 A study by Secinti, Thompson, Richards, and Gaysina (2017) highlights the association between childhood chronic physical conditions and adult emotional health, further emphasizing the critical need to address physical health as well as the emotional and mental health of children with asthma. 24 More distally, asthma, anxiety, and depression cause inflammation. 25 Left unaddressed, adults with asthma and comorbid anxiety/depression may be at higher risk of cardiovascular disease. 25,26 Compounding potential health related complications of asthma and comorbid anxiety/depressive symptoms is the disproportionate effect of asthma for children from ethnic and racial minority populations 4,19 or from socioeconomically disadvantaged settings. 19 Further, underserved populations are less likely to receive appropriate medical or mental health care for a variety of reasons such as transportation, neighborhood factors, a caregiver's inability to pay for needed medications or treatment, and healthcare provider bias. 20 Cost-related barriers were found to be most indicative of uncontrolled asthma in a recent study. 27 Clinicians, policy makers, and researchers must be responsive and provide interventions to ameliorate detrimental outcomes. Prior studies indicate that not only are children with asthma and anxiety/depression less likely to adhere to treatment guidelines, they are prone to misinterpretation of their symptoms leading to overuse of their quick-relief inhaler. 20 Symptoms of anxiety and asthma are often confused and psychological factors can be a trigger for an asthma attack. 25 Improvement in symptom interpretation, asthma self-efficacy, and asthma illness beliefs has been associated with better asthma control. 28 Children using skills to take care of their asthma, or asthma self-management, is a dynamic process. Self-efficacy contributes to one's to self-management behaviors. 29 While many factors contribute to managing one's asthma, the skills can be easily learned. However, children with asthma are frequently expected to manage their medications at a very young age and may not have the knowledge or skills yet to understand what actions to take and when. For example, a study by Orrell-Valente, Jarlsberg, Hill, and Cabana (2008) found that 20% of children aged 7 years were responsible for managing their asthma medications, and by age 11 years, 50% of children are left to manage their asthma medications without caregiver assistance. 30 Bellin and colleagues (2017) interviewed children as young as six years of age that self-administered their medication. 31 Because of this, educating children about asthma is imperative so they can more accurately interpret their symptoms and treat themselves for optimal health, particularly since it is a lifelong condition. The proposed one group pilot will determine the feasibility and acceptability of an 8-session educational and skills-building intervention in YMCA after-school programs in Orange and Chatham counties, and one school in Durham county in North Carolina.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One Group Pilot Study
| Arm | Type | Receives |
|---|---|---|
| One group pilot | Other | Behavioral: STRONGer TogetherThe experimental group will receive the intervention, which is an 8-week (30 minute session per week) asthma educational and cognitive behavioral skills program. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- In the range of 8 - 12 years of age,
- Child has a diagnosis of asthma or reactive airway and prescribed a controller medication or have intermittent symptoms,
- Child has at least slightly elevated anxiety or depressive symptoms upon screening at enrollment,
- The parent/caregiver can understand and answer the survey questions in English; child can understand English in a small group setting and can answer survey questions in English,
- The consenting parent/caregiver has at least equal responsibility for the day-to-day management of the child's asthma.
Key exclusion criteria (2 listed)
- Child has other pulmonary conditions (e.g., cystic fibrosis/pulmonary fibrosis),
- Child or parent/caregiver cannot answer the survey questions due to a cognitive delay.
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 |
|---|---|---|
| STRONGer TogetherSTRONGer (Successes/Strengths, Triggers, Remember your medications, Ongoing communication, Never give up!, Gratitude) Together is an asthma educational and cognitive behavioral skills intervention for children between 8 - 12 years of age. The intervention is implemented in small groups in 30-minute sessions. | Behavioural | One group pilot |
Primary outcome
Feasibility of the Intervention
Time frame: 8-weeks
Feasibility will be established if 80% of the participants attend 6 out of 8 sessions.
Acceptability related to the Intervention
Time frame: 8 weeks
Acceptability will be established if 80% of the child participants practice the skills or practice sheets.
Acceptability of the Intervention - for the Child Participants
Time frame: 8 weeks
Questions relate to satisfaction with the program and general like/dislike (rated 0 - 5; higher score reflects more satisfaction) and qualitative questions about what participants liked or would change about the program.
Acceptability of the Intervention - for the Parent/Caregiver Participants
Time frame: 8 weeks
Questions relate to overall satisfaction with the program (0 - 5; higher score reflects greater satisfaction) and qualitative questions about if/what their child learned from the program.
8 secondary outcomes
Asthma Management Self-Efficacy - Child
Time frame: From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.
Anxiety Measure (Screen for Child Anxiety Related Disorders [SCARED]) - Child
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Depression Measure (Patient-Reported Outcomes Measurement Information System [PROMIS]- Child Depression Short Form)
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Asthma Illness Representations - Child Version (AIRS-C)
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) - Child
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Peak Flow - Child
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Pediatric Symptom Checklist - completed by the Parent/Caregiver
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Asthma Control Test - Combined Child and Parent/Caregiver
Time frame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No. No IPD will be shared.
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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 principal investigator
University of North Carolina, Greensboro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRONGer Together in people with Childhood Asthma and Childhood Anxiety, run by University of North Carolina, Greensboro 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. 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?
Results are not available in the source record.
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?
Feasibility of the Intervention (time frame: 8-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.