Asthma in ChildrenNCT05118282
A Coping Skills Program for Children With Asthma
A study testing Combined coping skills + asthma management and Standard Asthma Management (AM) in people with Asthma in Children, run by Erin M Rodriguez at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Combined coping skills + asthma management and Standard Asthma Management (AM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2021to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria are that the presence of a disability interferes with the child's participation in the intervention beyond accommodations feasible in primary care.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Combined coping skills + asthma management, Standard Asthma Management (AM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined coping skills + asthma managementBehavioural
This arm includes a curriculum teaching coping skills and culturally relevant asthma management skills.
Standard Asthma Management (AM)Behavioural
This arm includes a curriculum teaching standard asthma management skills.
| Study group | Role | What they receive |
|---|---|---|
| Combined coping skills + asthma management arm | Experimental | 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. Receives: Behavioral: Combined coping skills + asthma management |
| Standard asthma management arm | Active comparator | 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. Receives: Behavioral: Standard Asthma Management (AM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: 1 week Post-intervention
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.
Measured: 1 week Post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: 12 months post-intervention
Secondary outcomes (40)
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").
Measured: Baseline
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").
Measured: 1 week post-intervention
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").
Measured: 6 months post-intervention
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").
Measured: 12 months post-intervention
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").
Measured: Baseline
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").
Measured: 1 week post-intervention
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").
Measured: 6 months post-intervention
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").
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
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.
Measured: Baseline
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.
Measured: 1 week post-intervention
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.
Measured: 6 months post-intervention
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.
Measured: 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start14 Nov 2021
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erin M Rodriguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erin M Rodriguez, University of Texas at Austin
- Investigators
- Erin M Rodriguez, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118282
- Sponsor's protocol ID
- 2017-04-0128
- Status last verified
- Feb 2026
- First submitted
- 14 Oct 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez EM, Westcott S, Calderon MPY, Horner SD, Matsui EC, Dillard J, Fareed H, Camacho J. Study protocol for a randomized controlled trial of Adapt 2 Asthma (A2A), a culturally relevant coping skills and asthma management intervention for Latinx Families. Trials. 2024 Oct 22;25(1):706. doi: 10.1186/s13063-024-08531-w.
PubMed 39438915
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Coping Skills Program for Children With Asthma
- ClinicalTrials.gov ID
- NCT05118282
- Acronym / sponsor ID
- 2017-04-0128
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Erin M RodriguezUniversity, hospital or other
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined coping skills + asthma management arm | Experimental | Behavioral: Combined coping skills + asthma managementThe 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. |
| Standard asthma management arm | Active comparator | Behavioral: Standard Asthma Management (AM)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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria are that the presence of a disability interferes with the child's participation in the intervention beyond accommodations feasible in primary care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined coping skills + asthma managementThis arm includes a curriculum teaching coping skills and culturally relevant asthma management skills. | Behavioural | Combined coping skills + asthma management arm |
| Standard Asthma Management (AM)This arm includes a curriculum teaching standard asthma management skills. | Behavioural | Standard asthma management arm |
Primary outcome
Asthma Control as measured by the Asthma Control Test (ACT)
Time frame: Baseline
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time frame: Baseline
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Asthma Control as measured by the Asthma Control Test (ACT)
Time frame: 1 week Post-intervention
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time frame: 1 week Post-intervention
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Asthma Control as measured by the Asthma Control Test (ACT)
Time frame: 6 months post-intervention
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Time frame: 6 months post-intervention
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Asthma Control as measured by the Asthma Control Test (ACT)
Time frame: 12 months post-intervention
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma 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.
40 secondary outcomes
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Time frame: Baseline
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Time frame: 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
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Time frame: 12 months post-intervention
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Time frame: Baseline
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Time frame: 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
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Time frame: 12 months post-intervention
Forced expiratory volume (FEV1) as measured by spirometry
Time frame: Baseline
Forced expiratory volume (FEV1) as measured by spirometry
Time frame: 1 week post-intervention
Forced expiratory volume (FEV1) as measured by spirometry
Time frame: 6 months post-intervention
Forced expiratory volume (FEV1) as measured by spirometry
Time frame: 12 months post-intervention
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: Baseline
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 1 week post-intervention
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 6 months post-intervention
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 12 months post-intervention
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: Baseline
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 1 week post-intervention
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 6 months post-intervention
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 12 months post-intervention
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: Baseline
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 1 week post-intervention
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 6 months post-intervention
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Time frame: 12 months post-intervention
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: Baseline
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 1 week post-intervention
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 6 months post-intervention
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 12 months post-intervention
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: Baseline
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 1 week post-intervention
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 6 months post-intervention
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 12 months post-intervention
Child self report of coping - Response to Stress Questionnaire (RSQ)
Time frame: Baseline
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 1 week post-intervention
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 6 months post-intervention
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
Time frame: 12 months post-intervention
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Time frame: Baseline
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Time frame: 1 week post-intervention
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Time frame: 6 months post-intervention
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Time frame: 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 39438915Rodriguez EM, Westcott S, Calderon MPY, Horner SD, Matsui EC, Dillard J, Fareed H, Camacho J. Study protocol for a randomized controlled trial of Adapt 2 Asthma (A2A), a culturally relevant coping skills and asthma management intervention for Latinx Families. Trials. 2024 Oct 22;25(1):706. doi: 10.1186/s13063-024-08531-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin M Rodriguez, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined coping skills + asthma management and Standard Asthma Management (AM) in people with Asthma in Children, run by Erin M Rodriguez at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control as measured by the Asthma Control Test (ACT) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.