Clinical trial NCT05118282: A Coping Skills Program for Children With Asthma
Official title: A Coping Skills Program for Children With Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 560
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Asthma Control as measured by the Asthma Control Test (ACT)
timeFrame: Baseline
measure: Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
timeFrame: Baseline
measure: Asthma Control as measured by the Asthma Control Test (ACT)
timeFrame: 1 week Post-intervention
measure: Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
timeFrame: 1 week Post-intervention
measure: Asthma Control as measured by the Asthma Control Test (ACT)
timeFrame: 6 months post-intervention
measure: Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
timeFrame: 6 months post-intervention
measure: Asthma Control as measured by the Asthma Control Test (ACT)
timeFrame: 12 months post-intervention
measure: Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
timeFrame: Baseline
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
timeFrame: 1 week post-intervention
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
timeFrame: 6 months post-intervention
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
timeFrame: 12 months post-intervention
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
timeFrame: Baseline
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
timeFrame: 1 week post-intervention
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
timeFrame: 6 months post-intervention
measure: Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
timeFrame: 12 months post-intervention
measure: Forced expiratory volume (FEV1) as measured by spirometry
timeFrame: Baseline
measure: Forced expiratory volume (FEV1) as measured by spirometry
timeFrame: 1 week post-intervention
measure: Forced expiratory volume (FEV1) as measured by spirometry
timeFrame: 6 months post-intervention
measure: Forced expiratory volume (FEV1) as measured by spirometry
timeFrame: 12 months post-intervention
measure: School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: Baseline
measure: School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 1 week post-intervention
measure: School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 6 months post-intervention
measure: School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 12 months post-intervention
measure: Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: Baseline
measure: Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 1 week post-intervention
measure: Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 6 months post-intervention
measure: Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 12 months post-intervention
measure: Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: Baseline
measure: Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 1 week post-intervention
measure: Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 6 months post-intervention
measure: Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
timeFrame: 12 months post-intervention
measure: Parent coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: Baseline
measure: Parent coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 1 week post-intervention
measure: Parent coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 6 months post-intervention
measure: Parent coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 12 months post-intervention
measure: Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: Baseline
measure: Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 1 week post-intervention
measure: Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 6 months post-intervention
measure: Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 12 months post-intervention
measure: Child self report of coping - Response to Stress Questionnaire (RSQ)
timeFrame: Baseline
measure: Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 1 week post-intervention
measure: Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 6 months post-intervention
measure: Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
timeFrame: 12 months post-intervention
measure: Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
timeFrame: Baseline
measure: Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
timeFrame: 1 week post-intervention
measure: Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
timeFrame: 6 months post-intervention
measure: Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
timeFrame: 12 months post-intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Erin M Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: