- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118282
A Coping Skills Program for Children With Asthma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erin M Rodriguez, PhD
- Phone Number: 512-471-0283
- Email: erodriguez@austin.utexas.edu
Study Contact Backup
- Name: Samantha Garcia Cruz, BA
- Phone Number: 512-475-7363
- Email: samantha.garciacruz@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- Recruiting
- University of Texas at Austin
-
Contact:
- Erin M Rodriguez, PhD
- Phone Number: 512-471-0283
- Email: erodriguez@austin.utexas.edu
-
Contact:
- Samantha Garcia Cruz, BA
- Phone Number: 512-475-7363
- Email: samantha.garciacruz@austin.utexas.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
This arm includes a curriculum teaching coping skills and culturally relevant asthma management skills.
|
Active Comparator: 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.
|
This arm includes a curriculum teaching standard asthma management skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
1 week Post-intervention
|
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.
|
1 week Post-intervention
|
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.
|
6 months post-intervention
|
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.
|
6 months post-intervention
|
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.
|
12 months post-intervention
|
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.
|
12 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
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").
|
Baseline
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
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").
|
1 week post-intervention
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
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").
|
6 months post-intervention
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
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").
|
12 months post-intervention
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
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").
|
Baseline
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
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").
|
1 week post-intervention
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
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").
|
6 months post-intervention
|
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
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").
|
12 months post-intervention
|
Forced expiratory volume (FEV1) as measured by spirometry
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.
|
Baseline
|
Forced expiratory volume (FEV1) as measured by spirometry
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.
|
1 week post-intervention
|
Forced expiratory volume (FEV1) as measured by spirometry
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.
|
6 months post-intervention
|
Forced expiratory volume (FEV1) as measured by spirometry
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.
|
12 months post-intervention
|
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
Baseline
|
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
1 week post-intervention
|
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
6 months post-intervention
|
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
12 months post-intervention
|
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
Baseline
|
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
1 week post-intervention
|
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
6 months post-intervention
|
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
12 months post-intervention
|
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
Baseline
|
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
1 week post-intervention
|
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
6 months post-intervention
|
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
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.
|
12 months post-intervention
|
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
Baseline
|
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
1 week post-intervention
|
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
6 months post-intervention
|
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
12 months post-intervention
|
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
Baseline
|
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
1 week post-intervention
|
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
6 months post-intervention
|
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
12 months post-intervention
|
Child self report of coping - Response to Stress Questionnaire (RSQ)
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.
|
Baseline
|
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
1 week post-intervention
|
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
6 months post-intervention
|
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
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.
|
12 months post-intervention
|
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
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.
|
Baseline
|
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
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.
|
1 week post-intervention
|
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
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.
|
6 months post-intervention
|
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
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.
|
12 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin M Rodriguez, PhD, University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-04-0128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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