Ignite Creation Date:
2024-05-06 @ 10:04 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03153696
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2017-05-02
Brief Title:
Initial Evaluation of the Cellie Coping Kit for Children With Injury
Sponsor:
Meghan Marsac
Organization:
University of Kentucky
Study Overview
Official Title:
Application of Theory and Evidence to Promote Full Recovery From Pediatric Injury
Status:
COMPLETED
Status Verified Date:
2020-02
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:
The purpose of this study is to assess the feasibility fidelity acceptability implementation cost of the Cellie Coping Kit for Children with Injury as well as to determine the interventions efficacy mechanisms of action and health outcomes
Detailed Description:
The goal of this study is to assess the Cellie Coping Kit for Injury intervention feasibility and initial efficacy
Aim 1 Intervention Feasibility Assess intervention feasibility implementation cost fidelity
Aim 2 Intervention Efficacy Mechanisms of Action and Health Outcomes Conduct initial efficacy evaluation of the Cellie Intervention on mechanisms of action adherence and coping behaviors and health outcomes physical recovery HRQOL emotional health
Hypotheses At 6-week follow-up T2 compared to a Treatment as Usual TAU control group parents in the intervention group will report greater adherence to medical discharge instructions H21 and encourage their child to use a higher number of adaptive coping strategies cognitive active support seeking H22 children in the intervention group will generate a greater number of adaptive coping strategies H23
Hypotheses At a 12-week follow-up T3 compared to TAU children in the intervention group will report better HRQOL and emotional health H24 parents in the intervention group will report better child HRQOL and child emotional health H25 Objective injury recovery scores will be higher for the intervention group H26
Method 80 children with injury and one parent per child will participate in a pilot RCT with a wait-list control design Participants will complete baseline assessments of targeted study variables prior to randomization 40 to the intervention 40 to usual care and then repeat measures 6 T2 12 T3 and 18 weeks T4 later Those in the immediate intervention condition will initiate the intervention following the T1 assessment Those in the wait-list condition will initiate the intervention following the T3 assessment
Aim 1 Intervention Feasibility Assess intervention feasibility implementation cost fidelity
Aim 2 Intervention Efficacy Mechanisms of Action and Health Outcomes Conduct initial efficacy evaluation of the Cellie Intervention on mechanisms of action adherence and coping behaviors and health outcomes physical recovery HRQOL emotional health
Hypotheses At 6-week follow-up T2 compared to a Treatment as Usual TAU control group parents in the intervention group will report greater adherence to medical discharge instructions H21 and encourage their child to use a higher number of adaptive coping strategies cognitive active support seeking H22 children in the intervention group will generate a greater number of adaptive coping strategies H23
Hypotheses At a 12-week follow-up T3 compared to TAU children in the intervention group will report better HRQOL and emotional health H24 parents in the intervention group will report better child HRQOL and child emotional health H25 Objective injury recovery scores will be higher for the intervention group H26
Method 80 children with injury and one parent per child will participate in a pilot RCT with a wait-list control design Participants will complete baseline assessments of targeted study variables prior to randomization 40 to the intervention 40 to usual care and then repeat measures 6 T2 12 T3 and 18 weeks T4 later Those in the immediate intervention condition will initiate the intervention following the T1 assessment Those in the wait-list condition will initiate the intervention following the T3 assessment
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