NCT04958694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
2.6 years until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

July 1, 2021

Last Update Submit

December 8, 2025

Conditions

Keywords

Adolescent BehaviorStress ReductionAdverse Childhood Experiences (ACEs)CEDARSPositive Affect Intervention

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 Weeks

  • Baseline, Midpoint, and Post-Intervention Surveys

    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

    There will be one follow-up survey with participants. The final survey will be 1 month post-intervention survey.

    4 weeks

Study Arms (2)

CEDARS- Active Intervention

EXPERIMENTAL

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.

Behavioral: CEDARS

CEDARS- Waitlisted Control

OTHER

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.

Behavioral: CEDARS

Interventions

CEDARSBEHAVIORAL

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

CEDARS- Active InterventionCEDARS- Waitlisted Control

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents ages 14-19
  • Adolescents able to speak and understand English fluently
  • Adolescents with reliable internet access (for virtual access to online modules)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nia Heard-Garris, MD,MSc,FAAP

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Wait-list control, no masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, FAAP

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 12, 2021

Study Start

February 29, 2024

Primary Completion

December 24, 2024

Study Completion

July 28, 2025

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations