Adolescent BehaviorCEDARSNCT04958694
CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention
A study testing CEDARS in people with Adolescent Behavior and Stress Reduction, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Stress Reduction, Adverse Childhood Experiences
- What is being tested?
- CEDARS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents ages 13-20
- Adolescents able to speak and understand English fluently
- Adolescents with reliable internet access (for virtual access to online modules)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Being tested
- CEDARS
- Keywords
- Adolescent Behavior, Stress Reduction, Adverse Childhood Experiences (ACEs), CEDARS, Positive Affect Intervention
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEDARSBehavioural
This intervention is intended to help adolescents cope with stress and improve positive affect.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CEDARS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Percentage of Recruitment Target Enrollment Met
This measurement reflects the number of participants recruited compared to the recruitment target goal.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Endpoint (8 Weeks after intervention start)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Midpoint, Endpoint. 1 Month Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start29 Feb 2024
- Primary completion24 Dec 2024
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nia Heard-Garris, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Nia Heard-Garris, MD,MSc,FAAP, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958694
- Sponsor's protocol ID
- IRB 2021-4642
- Other IDs
- K01HL147995-01
- Acronym
- CEDARS
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2021
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
- ClinicalTrials.gov ID
- NCT04958694
- Acronym / sponsor ID
- CEDARS / IRB 2021-4642
- Keywords
- Adolescent Behavior, Stress Reduction, Adverse Childhood Experiences (ACEs), CEDARS, Positive Affect Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEDARS- Active Intervention | Experimental | Behavioral: CEDARSUsing 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. |
| CEDARS- Waitlisted Control | Other | Behavioral: CEDARSThe 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents ages 13-20
- Adolescents able to speak and understand English fluently
- Adolescents with reliable internet access (for virtual access to online modules)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEDARSThis intervention is intended to help adolescents cope with stress and improve positive affect. | Behavioural | CEDARS- Active Intervention, CEDARS- Waitlisted Control |
Primary outcome
Feasibility: Percentage of Recruitment Target Enrollment Met
Time frame: Baseline
This measurement reflects the number of participants recruited compared to the recruitment target goal.
Feasibility:4 of 7 Intervention Modules Completed
Time frame: Endpoint (8 Weeks after intervention start)
Feasibility was defined as the proportion of participants who completed at least 4 of the 7 core intervention modules during the study period.
Feasibility: Mean Intervention Module Completion
Time frame: Endpoint (8 Weeks after intervention start)
Intervention module completion was defined as the mean number of modules the intervention participants completed during the study period.
Acceptability: Participant Satisfaction Score ≥8 of 10
Time frame: Endpoint (8 Weeks after intervention start)
Acceptability was defined as participant satisfaction with the intervention, measured using a 1-10 satisfaction scale, with scores ≥8 indicating intervention acceptability.
Acceptability: Mean Participant Satisfaction
Time frame: Endpoint (8 Weeks after intervention start)
Acceptability was defined as participant satisfaction with the intervention measured using a 1-10 satisfaction scale, with scores ≥8 indicating positive acceptability.
7 secondary outcomes
Depressive Symptoms
Time frame: Baseline, Midpoint (Week 4), Endpoint (Week 8), and 1-month follow-up
Anxiety Symptoms
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Positive Affect
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Perceived Stress
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Flourishing
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Negative Affect
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
Resilient Coping
Time frame: Baseline, Midpoint, Endpoint. 1 Month Post-Intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Aggression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nia Heard-Garris, MD,MSc,FAAP principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEDARS in people with Adolescent Behavior and Stress Reduction, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Percentage of Recruitment Target Enrollment Met (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.