A Coping Skills Program for Children With Asthma

NCT05118282 | Active Not Recruiting DMC

• 1 other identifier: 2017-04-0128
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (8)

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

  The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.

  Baseline

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

  The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.

  Baseline

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

  The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.

  1 week Post-intervention

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

  The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.

  1 week Post-intervention

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

  The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.

  6 months post-intervention

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

  The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.

  6 months post-intervention

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

  The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.

  12 months post-intervention

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

  The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.

  12 months post-intervention

Secondary Outcomes (40)

• Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report

  Baseline

• Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report

  1 week post-intervention

• Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report

  6 months post-intervention

• Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report

  12 months post-intervention

• Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report

  Baseline

Study Arms (2)

Combined coping skills + asthma management arm

EXPERIMENTAL

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.

Behavioral: Combined coping skills + asthma management

Standard asthma management arm

ACTIVE COMPARATOR

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.

Behavioral: Standard Asthma Management (AM)

Interventions

Standard Asthma Management (AM) BEHAVIORAL

This arm includes a curriculum teaching standard asthma management skills.

Standard asthma management arm

Combined coping skills + asthma management BEHAVIORAL

This arm includes a curriculum teaching coping skills and culturally relevant asthma management skills.

Combined coping skills + asthma management arm

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Rodriguez EM, Westcott S, Calderon MPY, Horner SD, Matsui EC, Dillard J, Fareed H, Camacho J. Study protocol for a randomized controlled trial of Adapt 2 Asthma (A2A), a culturally relevant coping skills and asthma management intervention for Latinx Families. Trials. 2024 Oct 22;25(1):706. doi: 10.1186/s13063-024-08531-w.

  PMID: 39438915 DERIVED

Study Officials

• Erin M Rodriguez, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 11, 2021
• Study Start: November 14, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)