- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958694
CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention (CEDARS)
Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents ages 14-19
- Adolescents able to speak and understand English fluently
- Adolescents with reliable internet access (for virtual access to online modules)
Exclusion Criteria:
- Individuals younger than age 14 and older than age 19
- Individuals who are not able to speak or understand English fluently
- Individuals without reliable internet access
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CEDARS- Active Intervention
Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=20) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction.
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This intervention is intended to help adolescents cope with stress and improve positive affect.
|
|
Other: CEDARS- Waitlisted Control
The investigators will use a wait-listed control for the pilot intervention in adolescents (N=20) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction.
|
This intervention is intended to help adolescents cope with stress and improve positive affect.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CEDARS Intervention
Time Frame: 8 Weeks
|
Participants will directly benefit from taking part in the interventions by learning and putting into practice new tools to reduce and manage their stress.
|
8 Weeks
|
|
Baseline, Midpoint, and Post-Intervention Surveys
Time Frame: 8 weeks
|
Participants will complete a baseline survey, a mid-point survey, and a post-intervention survey (after the completion of the last CEDARS online module).
|
8 weeks
|
|
Post-Intervention Follow-Up
Time Frame: 4 weeks
|
There will be one follow-up survey with participants.
The final survey will be 1 month post-intervention survey.
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nia Heard-Garris, MD,MSc,FAAP, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2021-4642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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