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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04958694
Other study ID # IRB 2021-4642
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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