Asthma in Children Clinical Trial
Official title:
A Coping Skills Program for Children With Asthma
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.
| Status | Recruiting |
| Enrollment | 560 |
| Est. completion date | April 2025 |
| Est. primary completion date | April 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Texas at Austin | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| University of Texas at Austin |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report | 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"). | Baseline | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report | 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"). | 1 week post-intervention | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report | 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"). | 6 months post-intervention | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report | 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"). | 12 months post-intervention | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report | 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"). | Baseline | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report | 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"). | 1 week post-intervention | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report | 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"). | 6 months post-intervention | |
| Secondary | Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report | 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"). | 12 months post-intervention | |
| Secondary | Forced expiratory volume (FEV1) as measured by spirometry | 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. | Baseline | |
| Secondary | Forced expiratory volume (FEV1) as measured by spirometry | 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. | 1 week post-intervention | |
| Secondary | Forced expiratory volume (FEV1) as measured by spirometry | 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. | 6 months post-intervention | |
| Secondary | Forced expiratory volume (FEV1) as measured by spirometry | 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. | 12 months post-intervention | |
| Secondary | School attendance as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | Baseline | |
| Secondary | School attendance as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 1 week post-intervention | |
| Secondary | School attendance as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 6 months post-intervention | |
| Secondary | School attendance as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 12 months post-intervention | |
| Secondary | Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | Baseline | |
| Secondary | Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 1 week post-intervention | |
| Secondary | Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 6 months post-intervention | |
| Secondary | Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 12 months post-intervention | |
| Secondary | Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | Baseline | |
| Secondary | Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 1 week post-intervention | |
| Secondary | Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 6 months post-intervention | |
| Secondary | Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ) | 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. | 12 months post-intervention | |
| Secondary | Parent coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | Baseline | |
| Secondary | Parent coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 1 week post-intervention | |
| Secondary | Parent coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 6 months post-intervention | |
| Secondary | Parent coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 12 months post-intervention | |
| Secondary | Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | Baseline | |
| Secondary | Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 1 week post-intervention | |
| Secondary | Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 6 months post-intervention | |
| Secondary | Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 12 months post-intervention | |
| Secondary | Child self report of coping - Response to Stress Questionnaire (RSQ) | 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. | Baseline | |
| Secondary | Child self report of coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 1 week post-intervention | |
| Secondary | Child self report of coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 6 months post-intervention | |
| Secondary | Child self report of coping as measured by the Response to Stress Questionnaire (RSQ) | 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. | 12 months post-intervention | |
| Secondary | Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS) | 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. | Baseline | |
| Secondary | Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS) | 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. | 1 week post-intervention | |
| Secondary | Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS) | 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. | 6 months post-intervention | |
| Secondary | Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS) | 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. | 12 months post-intervention |
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