Coping Skills Program for Childhood Asthma

Overseen By Samantha Garcia Cruz, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Disability interfering participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

560 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Latino families manage childhood asthma by teaching coping skills to handle stress and improve asthma management. It compares a new program that combines stress management with usual asthma care (Combined coping skills + asthma management) to standard asthma care alone. Children with asthma who are patients at certain clinics, are Latino, and speak English or Spanish may be eligible to participate. The goal is to determine if the combined program improves asthma control more effectively than standard care alone.

As an unphased trial, this study offers families a unique opportunity to contribute to innovative asthma management strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this coping skills program is safe for children with asthma?

Research shows that the combined coping skills and asthma management program is safe for children with asthma. A study with 280 children aged 6 to 12 found that lower stress levels were linked to better asthma control and improved coping skills. This finding indicates the program helps children manage stress and asthma more effectively, without any reported negative effects. Additionally, feedback from past participants revealed less separation anxiety and increased confidence and self-management skills. These outcomes suggest the program is not only safe but also beneficial, as no harmful effects have been noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Coping Skills Program for childhood asthma because it goes beyond traditional treatments by integrating stress management with asthma care. Unlike standard asthma management, which typically focuses on recognizing symptoms and self-monitoring, this program combines family-based coping strategies with asthma management, all tailored specifically for Latino families. It uses bilingual, culturally relevant content and interactive video-guided sessions to help both kids and parents manage stress and improve asthma control. This holistic approach aims to enhance overall well-being and could lead to better asthma outcomes by addressing both emotional and physical aspects of the condition.

What evidence suggests that this trial's treatments could be effective for childhood asthma?

Research has shown that teaching children with asthma how to handle stress can improve their asthma control. In a study with 280 children, those who learned stress-coping skills experienced lower stress levels, making asthma management easier. These children also felt less anxious and more confident in dealing with their asthma. In this trial, participants in the combined coping skills and asthma management arm will receive a program that integrates stress-coping skills with asthma management, which helps both children and their parents manage asthma symptoms more effectively. Overall, these coping strategies lead to better asthma outcomes compared to standard management alone, which is being tested in the standard asthma management arm of this trial. ^{1 2 3 4 6}

Who Is on the Research Team?

Erin M Rodriguez, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child has been diagnosed with asthma by their doctor.

This criterion does not seem to be related to a clinical trial exclusion criteria. Can you please provide more context or clarify what the criterion is referring to?

My child is between 8 and 14 years old.

Exclusion Criteria

My child's disability prevents them from participating in the treatment without special adjustments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Families complete assessments 1 week before the intervention, including surveys, interviews, and spirometry

1 week

1 visit (in-person)

Intervention

Participants receive either the combined coping skills + asthma management program or the standard asthma management program

6 weeks

Weekly sessions (in-person or virtual)

Post-intervention Assessment

Families complete assessments 1 week after the intervention, including surveys, interviews, and spirometry

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 6- and 12-month timepoints

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Combined coping skills + asthma management
• Standard Asthma Management (AM)

Trial Overview 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.

How Is the Trial Designed?

Group I: Combined coping skills + asthma management arm Experimental Treatment 1 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 arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

The Family Asthma Program significantly improved asthma knowledge and management skills for parents of children with asthma, but did not show similar benefits for the children aged 4 to 12.

There were no notable differences in family stress and coping characteristics between families participating in the program and those in other groups, indicating a need for program enhancements to better support children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a family asthma program for children and parents. Carson, DK., Council, JR., Schauer, RW.[2007]

Asthma programs aimed at families of children with asthma have successfully increased knowledge about the disease and its treatment in both parents and children, as shown by short-term evaluations.

These programs are designed to reduce morbidity and anxiety, improve coping skills, and promote family harmony, with long-term evaluations currently underway showing promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community and family programs for children with asthma. Hindi-Alexander, M., Cropp, GJ.[2007]

In a study of 47 children aged 8-15 with asthma, it was found that those who used more approach coping strategies had better psychological functioning and quality of life compared to those who relied on avoidant coping strategies.

The study also revealed that a child's quality of life is positively related to their mother's quality of life, suggesting that addressing coping strategies in both children and their mothers could enhance overall well-being in families affected by asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping styles, psychological functioning and quality of life in children with asthma. Marsac, ML., Funk, JB., Nelson, L.[2015]

In a study of 280 children aged 6 to 12 with asthma, lower stress levels were associated with better asthma control and more effective coping strategies, highlighting the importance of mental health in managing asthma.

The findings suggest that interventions aimed at reducing stress and improving coping mechanisms could enhance asthma management, indicating a need for support not just for patients but also for families and schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation to Asthma in Children: A Matter of Coping and Stress Control. Segura Moreno, CC., Diaz Heredia, LP.[2021]

A study involving 78 children with asthma found that coping strategies, particularly 'emotional reaction' and 'avoidance', significantly predict health-related quality of life (HRQoL).

The extended stress-coping model is effective in understanding how asthma impacts children's quality of life, suggesting that these coping factors should be considered in developing psychosocial care interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of quality of life: a quantitative investigation of the stress-coping model in children with asthma. Peeters, Y., Boersma, SN., Koopman, HM.[2021]

Patients with asthma often use emotion-focused coping strategies, like denial, which are linked to poor medication adherence and worse health outcomes, such as increased emergency department visits and hospitalizations.

Improving coping strategies through targeted interventions can reduce asthma symptoms and psychological distress, suggesting that addressing psychological factors is crucial for better asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping as a mediator of psychosocial impediments to optimal management and control of asthma. Barton, C., Clarke, D., Sulaiman, N., et al.[2022]

The Perceived Stress Scale (PSS) has been validated for use in asthma patients, demonstrating acceptable psychometric properties across different ethnic groups and literacy levels in two studies involving a total of 559 participants.

The short version of the PSS is an effective and quick tool for measuring subjective stress in diverse populations with asthma, making it useful for both clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Perceived Stress Scale for African American adults with asthma and low literacy. Sharp, LK., Kimmel, LG., Kee, R., et al.[2022]

A cognitive-educational intervention program for asthmatic patients significantly reduced emotional distress, such as anxiety and anger, and decreased their preoccupation with asthma after the program was implemented.

Patients who participated in the program also reported using less maintenance medication, specifically corticosteroids, indicating a potential improvement in their overall management of asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing health behaviour outcomes in asthmatic patients: a pilot intervention study. Maes, S., Schlösser, M.[2019]

In a pilot study involving 39 teens with asthma, those who received Coping Skills Training showed significant improvements in asthma self-efficacy and social support compared to a control group, indicating the intervention's effectiveness.

The treatment group also reported enhanced quality of life related to their asthma, suggesting that Coping Skills Training could be a valuable approach for improving outcomes in adolescents with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of coping skills training among teens with asthma. Srof, BJ., Velsor-Friedrich, B., Penckofer, S.[2022]

A stress management intervention for children with asthma was found to be highly acceptable and feasible, especially in a school setting, with 18 participants across two cohorts.

Initial results indicated improvements in lung function, perceived stress, and mood after the intervention, suggesting potential benefits for managing asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evidence for the feasibility of a stress management intervention for 7- to 12-year-olds with asthma. Long, KA., Ewing, LJ., Cohen, S., et al.[2015]

Patient adherence, asthma self-management skills, and exposure to stress are crucial factors that can significantly influence asthma outcomes, highlighting the need for their measurement in clinical research.

Standardized measures for these mediators can improve the understanding of how they affect treatment interventions, ultimately leading to better asthma management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of asthma outcomes. Rand, CS., Wright, RJ., Cabana, MD., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05118282

A Coping Skills Program for Children With Asthma The main hypothesis is that the combined coping skills + asthma management program will improve asthma outcomes more than the standard asthma management ...

2. withpower.com withpower.com/trial/phase-asthma-10-2021-1555a

Coping Skills Program for Childhood Asthma In a study of 280 children aged 6 to 12 with asthma, lower stress levels were associated with better asthma control and more effective coping strategies, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7260952/

COPE for Asthma: Outcomes of a Cognitive Behavioral ... Self-reported findings indicated a significant reduction in separation anxiety and increased personal beliefs, child-management self-efficacy, and asthma ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0882596324001064

Children and young people's self-reported experiences of ... Childhood asthma is an increasingly significant health issue, highlighting the importance of acquiring self-management skills to optimise future health outcomes ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/383955

A Coping Skills Program for Children With Asthma Specifically, the study will compare the effects of the combined coping skills + asthma management program with a standard asthma management ...

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08531-w

Study protocol for a randomized controlled trial of Adapt 2 ... The current randomized controlled trial tests the effects of Adapt 2 Asthma (A2A), a family-based coping skills and asthma management intervention.