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

Browse trials for

• Adolescent Behavior 305

Keywords

• Adolescent Behavior
• Stress Reduction
• Adverse Childhood Experiences (ACEs)
• CEDARS
• Positive Affect Intervention

Adolescent Behavior

305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.

This study's enrollment of 36 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 28 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Study arms

• 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

• 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

Interventions

• BehavioralCEDARS

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

Primary outcomes

1. Feasibility: Percentage of Recruitment Target Enrollment Met

   This measurement reflects the number of participants recruited compared to the recruitment target goal.

   Time frame: Baseline

2. 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.

   Time frame: Endpoint (8 Weeks after intervention start)

3. Feasibility: Mean Intervention Module Completion

   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)

4. 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.

   Time frame: Endpoint (8 Weeks after intervention start)

5. 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.

   Time frame: Endpoint (8 Weeks after intervention start)

Secondary outcomes

1. 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.

   Time frame: Baseline, Midpoint (Week 4), Endpoint (Week 8), and 1-month follow-up

2. 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.

   Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention

3. 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.

   Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention

4. 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.

   Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention

5. 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.

   Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention

6. 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.

   Time frame: Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention

7. 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.

   Time frame: Baseline, Midpoint, Endpoint. 1 Month Post-Intervention

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Apr 14, 2025
• Informed consent form ↗ · Nov 2, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided