University of Texas at Austin
Austin, Texas, 78712, United States
NCT Number: NCT05118282
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.
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Notify Me8 year and older
All sexes
Interventional
Not applicable
Austin, Texas, 78712, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This arm includes a curriculum teaching coping skills and culturally relevant asthma management skills.
This arm includes a curriculum teaching standard asthma management skills.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: 1 week post-intervention
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: 6 months post-intervention
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: 12 months post-intervention
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: Baseline
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: 1 week post-intervention
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: 6 months post-intervention
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: 12 months post-intervention
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time frame: Baseline
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time frame: 1 week post-intervention
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time frame: 6 months post-intervention
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time frame: 12 months post-intervention
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time frame: Baseline
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time frame: 1 week post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time frame: 6 months post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time frame: 12 months post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time frame: Baseline
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time frame: 1 week post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time frame: 6 months post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time frame: 12 months post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time frame: Baseline
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time frame: 1 week post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time frame: 6 months post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time frame: 12 months post-intervention
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time frame: Baseline
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time frame: 1 week post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time frame: 6 months post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time frame: 12 months post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time frame: Baseline
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time frame: 1 week post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time frame: 6 months post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time frame: 12 months post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time frame: Baseline
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time frame: 1 week post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time frame: 6 months post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time frame: 12 months post-intervention
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time frame: Baseline
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time frame: 1 week post-intervention
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time frame: 6 months post-intervention
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time frame: 12 months post-intervention
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Erin M Rodriguez
Other
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