Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03481673
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2017-11-20
Brief Title:
COPE for Children With Asthma Intervention for Children With Asthma
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
COPE for Children With Asthma A Cognitive Behavior Skills-Building
Status:
COMPLETED
Status Verified Date:
2018-08
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:
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition Asthma is the most common childhood chronic condition Children with asthma and co-morbid anxiety andor depression are at risk of poor health outcomes The purpose of this study is to evaluate the effects of a manualized cognitive behavior skills-building intervention on key physical and mental health outcomes in 8 to 12-year old children with persistent asthma and co-morbid anxiety andor depression The results of this study will inform a large scale randomized controlled trial to fully test this needed intervention
COPE Creating Opportunities for Personal Empowerment developed by Dr Melnyk is a manualized intervention that has been implemented with children adolescents and young adults COPE is a cognitive behavior skills-building program based on cognitive behavior theory Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings youth with obesity and teens experiencing chronic recurrent headaches However the COPE program has never been adapted and tested with children who have persistent asthma This study proposes to test an adaptation of this evidence-based program COPE for Asthma with 8 to 12-year-old children with persistent asthma and elevated anxiety andor depressive symptoms COPE for Asthma combines components of asthma education with cognitive behavioral skills This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population
COPE Creating Opportunities for Personal Empowerment developed by Dr Melnyk is a manualized intervention that has been implemented with children adolescents and young adults COPE is a cognitive behavior skills-building program based on cognitive behavior theory Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings youth with obesity and teens experiencing chronic recurrent headaches However the COPE program has never been adapted and tested with children who have persistent asthma This study proposes to test an adaptation of this evidence-based program COPE for Asthma with 8 to 12-year-old children with persistent asthma and elevated anxiety andor depressive symptoms COPE for Asthma combines components of asthma education with cognitive behavioral skills This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population
Detailed Description:
The Interventionist was trained on the implementation of the COPE intervention and will deliver the COPE for Asthma intervention The intervention delivered by Colleen McGovern -the Interventionist will take place in a room within the school separate from other students The room will include a door for privacy The intervention will be onceweek 30 minute sessions for 7 weeks - during lunch andor recess time Groups during lunch and recess or lunch bunch groups are routinely held in the school system by the social workers guidance counselors and school nurses Participants will be given weekly tickets allowing them to get in line first to pick up their lunch to maximize the allotted time If the material for a session is not covered ie school-wide fire drill lock down or other unforeseen event the session will be moved to the following week
In the event a participant has severely elevated t-scores 70 on the anxiety or depression screening tools or expresses feelings or intent to harm self or others at any time point or otherwise the principal school nurse andor guidance counselorsocial worker will be notified for follow-up per the school districts protocol A form letter will be sent to the childs CG that day If child discloses accounts of abuse or neglect Franklin County Childrens Services will be notified and the principal school nurse andor guidance counselorsocial worker
Consentassent of the CG and child and initial screening for anxietydepressionSCARED and PROMIS measures will be completed by the Interventionist and a research assistant RA from Dr Melnyks research team Data collection and the intervention will start when 5 childCG dyads have been consentedassented in a school
Week 1 at baseline To avoid bias the Interventionist will serve as the interventionist and the RA will complete the data gathering The measures for the child participants will be explained then self-administered and checked for completeness by the RA The RA will conduct phone interviews with the CGs to gather data on demographics controller medication adherence and the Asthma Control Test If phone contact is not possible the surveys will be sent home with the child with sealable envelopes for the return
Weeks 2 - 8 COPE for Asthma will be delivered in small groups Interventionist may need to implement the intervention at several schools on different days this is expected Lessons include 30 minutes of didactic teaching and activities
Post-Intervention Assessment after the 7-week intervention After the last COPE for Asthma session has been implemented in a group a member of Dr Melnyks research team will administer the post-intervention follow-up surveys CGs will be contacted to complete the parentCG survey
6-Week Post-Intervention Assessment The same procedure as for the post-intervention assessment will be conducted for this time period for the children and CGs
In the event a participant has severely elevated t-scores 70 on the anxiety or depression screening tools or expresses feelings or intent to harm self or others at any time point or otherwise the principal school nurse andor guidance counselorsocial worker will be notified for follow-up per the school districts protocol A form letter will be sent to the childs CG that day If child discloses accounts of abuse or neglect Franklin County Childrens Services will be notified and the principal school nurse andor guidance counselorsocial worker
Consentassent of the CG and child and initial screening for anxietydepressionSCARED and PROMIS measures will be completed by the Interventionist and a research assistant RA from Dr Melnyks research team Data collection and the intervention will start when 5 childCG dyads have been consentedassented in a school
Week 1 at baseline To avoid bias the Interventionist will serve as the interventionist and the RA will complete the data gathering The measures for the child participants will be explained then self-administered and checked for completeness by the RA The RA will conduct phone interviews with the CGs to gather data on demographics controller medication adherence and the Asthma Control Test If phone contact is not possible the surveys will be sent home with the child with sealable envelopes for the return
Weeks 2 - 8 COPE for Asthma will be delivered in small groups Interventionist may need to implement the intervention at several schools on different days this is expected Lessons include 30 minutes of didactic teaching and activities
Post-Intervention Assessment after the 7-week intervention After the last COPE for Asthma session has been implemented in a group a member of Dr Melnyks research team will administer the post-intervention follow-up surveys CGs will be contacted to complete the parentCG survey
6-Week Post-Intervention Assessment The same procedure as for the post-intervention assessment will be conducted for this time period for the children and CGs
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