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

NCT ID: NCT04958694

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-07-28

Brief Summary

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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

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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.

Conditions

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Adolescent Behavior Stress Reduction Adverse Childhood Experiences Positive Attitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Wait-list control, no masking

Study Groups

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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.

Group Type EXPERIMENTAL

CEDARS

Intervention Type BEHAVIORAL

This intervention is intended to help adolescents cope with stress and improve positive affect.

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.

Group Type OTHER

CEDARS

Intervention Type BEHAVIORAL

This intervention is intended to help adolescents cope with stress and improve positive affect.

Interventions

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CEDARS

This intervention is intended to help adolescents cope with stress and improve positive affect.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Nia Heard-Garris

MD, MSc, FAAP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nia Heard-Garris, MD,MSc,FAAP

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 2021-4642

Identifier Type: -

Identifier Source: org_study_id