A Coping Skills Program for Children With Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Combined coping skills + asthma management
- Conditions
- Asthma in Children
- Sponsor
- University of Texas at Austin
- Enrollment
- 282
- Locations
- 1
- Primary Endpoint
- Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria are that (a) the child has a diagnosis of asthma as reported by the child's medical provider and confirmed by the parent; (b) the child is a current patient at a participating clinic; (c) the child is 8 to 14 years old; (d) the child is Latino/a; and (e) the child and parent speak English or Spanish.
Exclusion Criteria
- •Exclusion criteria are that the presence of a disability interferes with the child's participation in the intervention beyond accommodations feasible in primary care.
Arms & Interventions
Combined coping skills + asthma management arm
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.
Intervention: Combined coping skills + asthma management
Standard asthma management arm
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.
Intervention: Standard Asthma Management (AM)
Outcomes
Primary Outcomes
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time Frame: 12 months post-intervention
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.
Asthma Control as measured by the Asthma Control Test (ACT)
Time Frame: 12 months post-intervention
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.
Asthma Control as measured by the Asthma Control Test (ACT)
Time Frame: Baseline
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.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time Frame: Baseline
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.
Asthma Control as measured by the Asthma Control Test (ACT)
Time Frame: 1 week Post-intervention
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.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time Frame: 1 week Post-intervention
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.
Asthma Control as measured by the Asthma Control Test (ACT)
Time Frame: 6 months post-intervention
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.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time Frame: 6 months post-intervention
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.
Secondary Outcomes
- Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report(12 months post-intervention)
- Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)(12 months post-intervention)
- Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)(12 months post-intervention)
- Parent coping as measured by the Response to Stress Questionnaire (RSQ)(12 months post-intervention)
- Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)(12 months post-intervention)
- Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)(12 months post-intervention)
- Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report(12 months post-intervention)
- Child self report of coping - Response to Stress Questionnaire (RSQ)(Baseline)
- Forced expiratory volume (FEV1) as measured by spirometry(12 months post-intervention)
- School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)(12 months post-intervention)
- Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)(12 months post-intervention)
- 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) Child Self Report(Baseline)
- Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report(1 week post-intervention)
- Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report(6 months post-intervention)
- Forced expiratory volume (FEV1) as measured by spirometry(Baseline)
- Forced expiratory volume (FEV1) as measured by spirometry(1 week post-intervention)
- Forced expiratory volume (FEV1) as measured by spirometry(6 months post-intervention)
- School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)(Baseline)
- School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)(1 week post-intervention)
- School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)(6 months post-intervention)
- Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)(Baseline)
- Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)(1 week post-intervention)
- Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)(6 months post-intervention)
- Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)(Baseline)
- Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)(1 week post-intervention)
- Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)(6 months post-intervention)
- Parent coping as measured by the Response to Stress Questionnaire (RSQ)(Baseline)
- Parent coping as measured by the Response to Stress Questionnaire (RSQ)(1 week post-intervention)
- Parent coping as measured by the Response to Stress Questionnaire (RSQ)(6 months post-intervention)
- Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)(Baseline)
- Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)(1 week post-intervention)
- Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)(6 months post-intervention)
- Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)(1 week post-intervention)
- Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)(6 months post-intervention)
- Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)(Baseline)
- Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)(1 week post-intervention)
- Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)(6 months post-intervention)