CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention

Adolescent Behavior Clinical Trial

— CEDARS  

Official title:

Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04958694
• Other study ID #: IRB 2021-4642
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Nia Heard-Garris, MD,MSc,FAAP
• Phone: (312) 227-2610
• Email: nheardgarris[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using an adapted stress-reduction intervention called the CEDARS, we will pilot the intervention in adolescents (N=50) 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.

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 affect.The 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

Inclusion Criteria:

• Adolescents ages 11-19

• Adolescents able to speak and understand English fluently

• Adolescents with reliable internet access (for virtual focus groups)

Exclusion Criteria:

• Individuals younger than age 11 and older than age 19

• Individuals who are not able to speak or understand English fluently

• Individuals without reliable internet access

Related Conditions & MeSH terms

• Adolescent Behavior
• Adverse Childhood Experiences
• Stress Reduction

Intervention

Behavioral:
• CEDARS
This intervention is intended to help adolescents cope with stress.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CEDARS Intervention	Participants will directly benefit from taking part in the interventions by learning and putting into practice new tools to reduce and manage their stress.	7 Weeks
Primary	Baseline and Post-Intervention Surveys	Participants will complete a baseline survey and then a post-intervention survey	8 weeks
Primary	Post-Intervention Follow-Up	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 at 12 months	12 months