Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
NCT Number: NCT04958694
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.
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Notify Me14 year–19 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention is intended to help adolescents cope with stress and improve positive affect.
Time frame: Baseline
This measurement reflects the number of participants recruited compared to the recruitment target goal.
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.
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.
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.
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.
Time frame: Baseline, Midpoint (Week 4), Endpoint (Week 8), and 1-month follow-up
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.
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
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.
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
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.
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
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.
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
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.
Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention
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.
Time frame: Baseline, Midpoint, Endpoint. 1 Month Post-Intervention
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.
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
Acronym: CEDARS
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