Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01653288
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2012-07-25
Brief Title:
A Trial of Coping Coach a Web-based Preventive Intervention for Children
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
A Randomized Controlled Trial of Coping Coach a Web-based Preventive Intervention for Children
Status:
COMPLETED
Status Verified Date:
2019-02
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:
This study will evaluate the impact of a psychosocial intervention Coping Coach delivered online to children who have experience an acute medical event
The core study hypotheses are that children receiving the intervention will 1 endorse fewer maladaptive trauma-related appraisals and 2 demonstrate more adaptive coping more support-seeking more cognitive restructuring less avoidant coping at a 6-week follow-up and 3 demonstrate lower severity of post traumatic stress PTS symptoms and higher health related quality of life HRQOL at 12 week follow-up
The core study hypotheses are that children receiving the intervention will 1 endorse fewer maladaptive trauma-related appraisals and 2 demonstrate more adaptive coping more support-seeking more cognitive restructuring less avoidant coping at a 6-week follow-up and 3 demonstrate lower severity of post traumatic stress PTS symptoms and higher health related quality of life HRQOL at 12 week follow-up
Detailed Description:
The purpose of this study is to evaluate the feasibility and provide an initial evaluation of the efficacy of Coping Coach a new web-based intervention for children experiencing acute medical events
The study aims to 1 assess and maximize intervention feasibility 2 conduct an initial efficacy testing pilot RCT for proximal outcomes appraisals coping and subsequent child health outcomes PTS reactions HRQOL and 3 refine the conceptual framework and optimize the intervention effectiveness
Study Design
This study will progress in multiple stages
Pilot study 20 children experiencing a potentially traumatic medical event will be given the Coping Coach intervention with follow-up at 6 weeks This pilot will examine initial feasibility usability acceptability and child engagement comprehension of the intervention
Additional Pilot Study 2015 20 children treated in the ED or admitted to the hospital with injury due to non-family violence will be provided with the Coping Coach intervention Other inclusion and exclusion criteria as well as baseline 6- and 12-week assessments parallel those from the RCT stage described below This pilot will examine feasibility engagement and estimate pre-post changes in key measures in children with violence exposure
RCT A wait-list design will compare intervention use with a waitlist control on proximal and child health outcomes at 6 12 and 18 weeks after baseline enrollment The Coping Coach intervention will be provided to the waitlist control after the 12 week assessment 70 children will be enrolled 35 in each arm Assessment of feasibility and engagement will continue in this stage
The rest of this CLINICALTRIALSGOV record describes the RCT N72
The Pilot and RCT combined will help us prepare for rigorous large-scale RCT of Coping Coach
The study aims to 1 assess and maximize intervention feasibility 2 conduct an initial efficacy testing pilot RCT for proximal outcomes appraisals coping and subsequent child health outcomes PTS reactions HRQOL and 3 refine the conceptual framework and optimize the intervention effectiveness
Study Design
This study will progress in multiple stages
Pilot study 20 children experiencing a potentially traumatic medical event will be given the Coping Coach intervention with follow-up at 6 weeks This pilot will examine initial feasibility usability acceptability and child engagement comprehension of the intervention
Additional Pilot Study 2015 20 children treated in the ED or admitted to the hospital with injury due to non-family violence will be provided with the Coping Coach intervention Other inclusion and exclusion criteria as well as baseline 6- and 12-week assessments parallel those from the RCT stage described below This pilot will examine feasibility engagement and estimate pre-post changes in key measures in children with violence exposure
RCT A wait-list design will compare intervention use with a waitlist control on proximal and child health outcomes at 6 12 and 18 weeks after baseline enrollment The Coping Coach intervention will be provided to the waitlist control after the 12 week assessment 70 children will be enrolled 35 in each arm Assessment of feasibility and engagement will continue in this stage
The rest of this CLINICALTRIALSGOV record describes the RCT N72
The Pilot and RCT combined will help us prepare for rigorous large-scale RCT of Coping Coach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21HD069832-01A1 | NIH | None | httpsreporternihgovquickSearch1R21HD069832-01A1 |