Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT04958694
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Organization:
Study Overview
Official Title:
Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
Status:
COMPLETED
Status Verified Date:
2025-12
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, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators 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 - 20 in the intervention group and 20 in the waitlisted group.
Adolescents in the intervention group will participate in 7 weekly, 1-hour sessions. This online intervention will feature positive affect and stress reduction skills delivered via self-paced and self-guided modules. The skills are taught through brief didactic and semi-interactive videos followed by invitations and opportunities for practice within the session and at home. Participants will complete a baseline, mid-point, and post-intervention survey to determine the influence of the intervention.
There will be one follow-up survey with participants after the intervention. The survey will take place 1 month after the program has concluded.
Participants will be divided into two groups - 20 in the intervention group and 20 in the waitlisted group.
Adolescents in the intervention group will participate in 7 weekly, 1-hour sessions. This online intervention will feature positive affect and stress reduction skills delivered via self-paced and self-guided modules. The skills are taught through brief didactic and semi-interactive videos followed by invitations and opportunities for practice within the session and at home. Participants will complete a baseline, mid-point, and post-intervention survey to determine the influence of the intervention.
There will be one follow-up survey with participants after the intervention. The survey will take place 1 month after the program has concluded.
Study Oversight
Has Oversight DMC:
False
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?: