STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression

Childhood Asthma Clinical Trial

Official title:

STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04089085
• Other study ID #: 19-1290
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: University of North Carolina, Greensboro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Asthma
• Childhood Anxiety
• Childhood Asthma
• Childhood Depression
• Depression
• Depressive Disorder

Intervention

Behavioral:
• STRONGer Together
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.

Locations

Country	Name	City	State
United States	Excelsior School	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Greensboro	Sigma Theta Tau International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Intervention	Feasibility will be established if 80% of the participants attend 6 out of 8 sessions.	8-weeks
Primary	Acceptability related to the Intervention	Acceptability will be established if 80% of the child participants practice the skills or practice sheets.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Secondary	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.	From baseline to post-intervention (8-weeks) and at 16 weeks post-intervention.
Secondary	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.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Secondary	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.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Secondary	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.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Secondary	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.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Secondary	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.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Secondary	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; a = .89). Examples of questions include "My child feels sad, unhappy" and "Daydreams too much." Higher scores indicate more symptoms.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention
Secondary	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 (a = .79; Lui et al., 2007; Lui et al., 2010) classifies children as very poorly controlled, not well-controlled, or well controlled.	From baseline to 8 weeks (immediately post-intervention) and 16 weeks post-intervention