Clinical trial NCT04089085: STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression
Official title: STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Asthma
Childhood Anxiety
Childhood Depression
Keywords: Childhood Asthma
Childhood Anxiety/depression
Educational and Behavioral Intervention for Children
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International
First posted: 2019-09-13
Enrollment: 14
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One Group Pilot Study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: 8-weeks
measure: Acceptability related to the Intervention
timeFrame: 8 weeks
measure: Acceptability of the Intervention - for the Child Participants
timeFrame: 8 weeks
measure: Acceptability of the Intervention - for the Parent/Caregiver Participants
timeFrame: 8 weeks
Secondary outcomes:
measure: Asthma Management Self-Efficacy - Child
timeFrame: From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.
measure: Anxiety Measure (Screen for Child Anxiety Related Disorders [SCARED]) - Child
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
measure: Depression Measure (Patient-Reported Outcomes Measurement Information System [PROMIS]- Child Depression Short Form)
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
measure: Asthma Illness Representations - Child Version (AIRS-C)
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
measure: Pediatric Asthma Quality of Life Questionnaire (PAQLQ) - Child
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
measure: Peak Flow - Child
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
measure: Pediatric Symptom Checklist - completed by the Parent/Caregiver
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
measure: Asthma Control Test - Combined Child and Parent/Caregiver
timeFrame: From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: Excelsior School
state: North Carolina
Study officials:
affiliation: University of North Carolina, Greensboro
name: Colleen McGovern, PhD
role: PRINCIPAL_INVESTIGATOR
References: