Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05118282
Status:
RECRUITING
Last Update Posted:
2023-03-27
First Post:
2021-10-14
Brief Title:
A Coping Skills Program for Children With Asthma
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
A Coping Skills Program for Children With Asthma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Uncontrolled asthma in school-aged children is a significant public health problem Latino children living in low-income contexts are at increased risk for uncontrolled asthma compared to non-Latino white children and stress is an unaddressed factor in this disparity Therefore the purpose of the current study is to test an intervention program that teaches families skills to cope with asthma-related and other sources of stress Specifically the study will compare the effects of the combined coping skills asthma management program with a standard asthma management program in 280 families of Latino children with asthma The study will also look at why the program may have an effect and specifically whether the program impacts child coping parent coping or family asthma management behaviors The main hypothesis is that the combined coping skills asthma management program will improve asthma outcomes more than the standard asthma management program
Detailed Description:
This study is a randomized controlled trial RCT examining the effects and mediators of Adapt 2 Asthma A2A a coping skills asthma management intervention compared to standard asthma self-management AM for Latino children with asthma and their parentscaregivers 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 parentscaregivers will participate The investigators will enroll 280 youth who are patients at the partner primary care clinics and 280 of their parentscaregivers 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 parentscaregivers will provide all data Participant data will be de-identified and stored in the principal investigators locked laboratory and all computerized data will be encrypted with University approved encryption software to ensure the confidentiality integrity and availability of data
Children ages 8 to 14 years old with asthma and their parentscaregivers will participate The investigators will enroll 280 youth who are patients at the partner primary care clinics and 280 of their parentscaregivers 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 parentscaregivers will provide all data Participant data will be de-identified and stored in the principal investigators locked laboratory and all computerized data will be encrypted with University approved encryption software to ensure the confidentiality integrity and availability of data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None