Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04958694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-07
First Post:
2021-07-01
Brief Title:
CEDARS Intervention A Coping Emotional Development Stress Reduction Intervention
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
CEDARS
Brief Summary:
Using an adapted stress-reduction intervention called the CEDARS we will pilot the intervention in adolescents N50 to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction As an exploratory aim we will explore the influence of the CEDARS on CMH-related behaviors and CMH We expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers
Detailed Description:
This intervention has been adapted based on feedback from previous focus groups with adolescents clinical staff community stakeholders and a CEDARS workgroup
Participants will be divided into two groups - 25 in the intervention group and 25 the waitlisted group Each group will be divided into smaller cohorts to build rapport and ensure appropriate attention is given to all participants
Adolescents in the intervention group will participate in 7 weekly 1-hour sessions These sessions will take place over Zoom and be led by a trained facilitator who will teach adolescents empirically supported strategies for increasing positive affectThe skills are taught through brief didactic presentations followed by interactive activities and games that provide opportunities for practice Participants will complete a baseline and post-intervention survey to determine the impact of the intervention
There will be three follow-up sessions with participants The first one will take place 3 months after the program has concluded the second one at 6 months and the last one at12 months
Participants will be divided into two groups - 25 in the intervention group and 25 the waitlisted group Each group will be divided into smaller cohorts to build rapport and ensure appropriate attention is given to all participants
Adolescents in the intervention group will participate in 7 weekly 1-hour sessions These sessions will take place over Zoom and be led by a trained facilitator who will teach adolescents empirically supported strategies for increasing positive affectThe skills are taught through brief didactic presentations followed by interactive activities and games that provide opportunities for practice Participants will complete a baseline and post-intervention survey to determine the impact of the intervention
There will be three follow-up sessions with participants The first one will take place 3 months after the program has concluded the second one at 6 months and the last one at12 months
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