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Active Not RecruitingNCT05118282

A Coping Skills Program for Children With Asthma

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
282 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
8 Years
Healthy volunteers
Not accepted

Summary

Uncontrolled asthma in school-aged children is a significant public health problem. Latino children living in low-income contexts are at increased risk for uncontrolled asthma compared to non-Latino white children, and stress is an unaddressed factor in this disparity. Therefore, the purpose of the current study is to test an intervention program that teaches families skills to cope with asthma-related and other sources of stress. Specifically, the study will compare the effects of the combined coping skills + asthma management program with a standard asthma management program in 280 families of Latino children with asthma. The study will also look at why the program may have an effect, and specifically whether the program impacts child coping, parent coping, or family asthma management behaviors. The main hypothesis is that the combined coping skills + asthma management program will improve asthma outcomes more than the standard asthma management program.

Detailed description

This study is a randomized controlled trial (RCT) examining the effects and mediators of Adapt 2 Asthma (A2A), a coping skills + asthma management intervention, compared to standard asthma self-management (AM) for Latino children with asthma and their parents/caregivers living in low-socioeconomic status (SES) contexts. The focus of the study is to test the effects of A2A on asthma control, quality of life, lung function, school absences, and emergency department visits, and to identify child and parent mediational pathways of A2A. Children ages 8 to 14 years old with asthma and their parents/caregivers will participate. The investigators will enroll 280 youth who are patients at the partner primary care clinics and 280 of their parents/caregivers to participate. The investigators will identify patients with asthma in the study age range through reviewing records from the partner clinics as well as natural referral when patients attend appointments. The investigators will screen identified patients for eligibility. Enrolled families will complete assessments at 1 week pre-intervention, 1 week post-intervention, and at 6- and 12-month follow-up timepoints. Research staff will collect assessment data in the form of child and parent surveys, interviews and spirometry. Providers will also audiotape sessions, which will be used for case supervision and to measure fidelity to the intervention. Youth and parents/caregivers will provide all data. Participant data will be de-identified and stored in the principal investigator's locked laboratory, and all computerized data will be encrypted with University approved encryption software to ensure the confidentiality, integrity and availability of data.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCombined coping skills + asthma managementThis arm includes a curriculum teaching coping skills and culturally relevant asthma management skills.
BEHAVIORALStandard Asthma Management (AM)This arm includes a curriculum teaching standard asthma management skills.

Timeline

Start date
2021-11-14
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2021-11-11
Last updated
2026-02-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05118282. Inclusion in this directory is not an endorsement.