What side effects are associated with this type of intervention?

Common treatments for childhood asthma include inhaled corticosteroids, bronchodilators, and leukotriene modifiers. Inhaled corticosteroids can cause oral thrush, hoarseness, and occasionally growth suppression. Bronchodilators may lead to jitteriness, increased heart rate, and headaches. Leukotriene modifiers can result in mood changes and gastrointestinal issues. The coping skills component, which helps manage stress, typically has minimal physical side effects but requires time and effort to practice.

What prior FDA approvals exist?

The FDA has approved several treatments for childhood asthma, including inhaled corticosteroids (ICS) like beclomethasone and fluticasone, and long-acting beta agonists (LABAs) such as salmeterol. Combination therapies, such as salmeterol/fluticasone, have also been approved and are commonly used to manage persistent asthma in children. These treatments focus on reducing inflammation and preventing asthma attacks. The Combined Coping Skills + Asthma Management Program being studied aims to enhance these standard treatments by teaching families coping skills to manage asthma-related stress, potentially improving overall asthma outcomes.

What other types of research exist?

Promising alternatives to the Combined Coping Skills + Asthma Management Program for childhood asthma patients include: 1) Asthma self-management programs tailored for adolescents, which focus on enhancing self-efficacy and prevention behaviors. 2) Integrative health approaches such as guided imagery, hypnosis, and biofeedback, which have been shown to help manage stress and improve asthma symptoms. 3) Complementary therapies like probiotics, which have potential benefits in reducing inflammation and improving overall health. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Coping Skills Program for Childhood Asthma

N/A

Recruiting

Led By Erin M Rodriguez, PhD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The child has a diagnosis of asthma as reported by the child's medical provider and confirmed by the parent

The child is 8 to 14 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program that teaches Latino children with asthma and their families how to manage asthma and cope with stress. The goal is to see if this combined approach improves asthma control. The study involves 280 families and measures outcomes like lung function, school absences, and emergency visits. The intervention, 'ACT-Asma Control y Tratamiento Para Niños,' was adapted from ACT for Kids, an asthma self-management program for English-speaking families.

Who is the study for?

This trial is for Latino children aged 8-14 with asthma, and their families. Participants must speak English or Spanish, have a confirmed asthma diagnosis, and be patients at a participating clinic. Children with disabilities that prevent participation beyond primary care accommodations cannot join.

What is being tested?

The study tests a coping skills program combined with standard asthma management against the standard treatment alone in Latino children living in low-income areas. It aims to see if adding coping strategies helps manage stress-related factors contributing to uncontrolled asthma.

What are the potential side effects?

Since this trial focuses on coping skills and standard asthma management techniques rather than medication, there are no direct medical side effects expected from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child has been diagnosed with asthma by their doctor.

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My child is between 8 and 14 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma Control as measured by the Asthma Control Test (ACT)

Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)

Secondary study objectives

Child self report of coping - Response to Stress Questionnaire (RSQ)

Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)

Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Combined coping skills + asthma management armExperimental Treatment1 Intervention

The combined coping skills + asthma management arm is a family-based coping skills + asthma management intervention that is bilingual and culturally relevant for Latino families. This program is manualized with video-guided and interactive content to improve coping with stress and asthma management behaviors for both children and their parents. Coping strategies taught include primary and secondary control coping. Asthma management content is interactive and culturally tailored.

Group II: Standard asthma management armActive Control1 Intervention

The standard asthma management (AM) arm is an asthma management intervention covering standard asthma self-management content (e.g., symptom recognition, self-monitoring). AM is manualized and is matched in length, time, and number of sessions to the experimental arm.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for childhood asthma include inhaled corticosteroids (ICS) and beta-agonists. ICS work by reducing inflammation in the airways, making them less sensitive and reducing the frequency of asthma attacks. Beta-agonists, such as albuterol, relax the muscles around the airways, making it easier to breathe during an asthma attack. The Combined Coping Skills + Asthma Management Program adds a focus on stress management, teaching families skills to cope with asthma-related and other sources of stress. This is important because stress can exacerbate asthma symptoms, and managing it can lead to better overall asthma control and fewer severe attacks.