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

Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior; Stress Reduction; Adverse Childhood Experiences; Positive Attitude
• Intervention / Treatment: Behavioral: CEDARS

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: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescents ages 13-20
• 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 13 and older than age 20
• 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)

Number of Arms

2

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.	Behavioral: CEDARS; 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.	Behavioral: CEDARS; 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
Feasibility: Percentage of Recruitment Target Enrollment Met	This measurement reflects the number of participants recruited compared to the recruitment target goal.	Baseline
Feasibility:4 of 7 Intervention Modules Completed	Feasibility was defined as the proportion of participants who completed at least 4 of the 7 core intervention modules during the study period.	Endpoint (8 Weeks after intervention start)
Feasibility: Mean Intervention Module Completion	Intervention module completion was defined as the mean number of modules the intervention participants completed during the study period.	Endpoint (8 Weeks after intervention start)
Acceptability: Participant Satisfaction Score ≥8 of 10	Acceptability was defined as participant satisfaction with the intervention, measured using a 1-10 satisfaction scale, with scores ≥8 indicating intervention acceptability.	Endpoint (8 Weeks after intervention start)
Acceptability: Mean Participant Satisfaction	Acceptability was defined as participant satisfaction with the intervention measured using a 1-10 satisfaction scale, with scores ≥8 indicating positive acceptability.	Endpoint (8 Weeks after intervention start)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	The PHQ-9 is a self-administered depression module of the Patient Health Questionnaire (PHQ). It contains 9 questions that help identify patients with clinically meaningful symptoms of depression. Patient responses are scored 0-3 with 0 representing "not at all" and 3 indicating "nearly every day;" thus, the PHQ-9 contains a total score range of 0-27. Higher scores indicate more severe depressive symptoms. No specific administration time could be found, but a reasonable administration time is approximately 5-10 minutes for cognitively intact patients. PHQ-9 questions are straightforward and pertain to depressive symptoms experienced over the past 2 weeks that include anhedonia, dysphoria, sleep disturbances, fatigue, changes in eating, low self-esteem, concentration difficulties, hypo-or-hyper-active behaviors, and thoughts of suicide or homicide.	Baseline, Midpoint (Week 4), Endpoint (Week 8), and 1-month follow-up
Anxiety Symptoms	The GAD-7 is a 7-item self-report questionnaire used to measure the severity of generalized anxiety disorder, with total scores ranging from 0 to 21 based on a 4-point scale (0-3). Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. A score of 10 or higher is the recommended threshold for identifying probable cases of GAD.	Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Positive Affect	PANAS-C SF Scale: In this 10-item scale, the 5 positive affect (PA) items are summed to obtain a PA score, and the 5 negative affect (NA) items are summed to obtain an NA score. Each question is scored 1- "not much or not at all" to 5- "a lot. Higher scores on each scale indicate higher levels of engagement within that particular affect, although there is no cutoff threshold.	Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Perceived Stress	The Perceived Stress Scale (PSS) is a widely used, self-report psychological instrument designed to measure the degree to which individuals appraise situations in their lives as uncontrollable, unpredictable, and overwhelming. The general scoring guidelines are 0-13: Low stress, 14-26: Moderate stress, 27-40: High perceived stress.	Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Flourishing	The Flourishing Scale (FS; Diener et al., 2010) is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. It was designed to measure social-psychological prosperity and to complement existing measures of subjective well-being. The FS provides a single psychological well-being score. All items are rated on a 7-point Likert-type scale where 1 = strongly disagree and 7 = strongly agree. All items are phrased in a positive direction. Scores can range from 8 (Strong Disagreement with all items) to 56 (Strong Agreement with all items). Higher scores indicate greater flourshing.	Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Negative Affect	PANAS-C SF Scale: In this 10-item scale, the 5 positive affect (PA) items are summed to obtain a PA score, and the 5 negative affect (NA) items are summed to obtain an NA score. Each question is scored 1- "not much or not at all" to 5- "a lot. Higher scores on each scale indicate higher levels of engagement within that particular affect, although there is no cutoff threshold.	Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Resilient Coping	The Brief Resilient Coping Scale captures tendencies to cope with stress adaptively. The scale focuses on the tendency to effectively use coping strategies in flexible, committed ways to actively solve problems despite stressful circumstances. Total score: Total sum scores range from 4 to 20. Scores of 4-13 indicate low resilient coping, 14-16 indicate medium resilient coping and 17-20 indicate high resilient coping.	Baseline, Midpoint, Endpoint. 1 Month Post-Intervention

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• 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): February 29, 2024
• Primary Completion (Actual): December 24, 2024
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent Behavior; Stress Reduction; Adverse Childhood Experiences (ACEs); CEDARS; Positive Affect Intervention
• Additional Relevant MeSH Terms: Behavior; Adolescent Behavior
• Other Study ID Numbers: IRB 2021-4642; K01HL147995-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No