Adolescent Behavior, Adverse Childhood Experiences, Positive Attitude, Stress Reduction
Conditions
Keywords
Adolescent Behavior, Stress Reduction, Adverse Childhood Experiences (ACEs), CEDARS, Positive Affect Intervention
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.
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.
Interventions
BEHAVIORALCEDARS
This intervention is intended to help adolescents cope with stress and improve positive affect.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Wait-list control, no masking
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percentage of Recruitment Target Enrollment Met | Baseline | This measurement reflects the number of participants recruited compared to the recruitment target goal. |
| Feasibility:4 of 7 Intervention Modules Completed | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Affect | 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. |
| Positive Affect | 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. |
| Resilient Coping | 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. |
| Perceived Stress | 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. |
| Depressive Symptoms | 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. |
| Anxiety Symptoms | 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. |
| Flourishing | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNia Heard-Garris, MD,MSc,FAAP
Ann & Robert H Lurie Children's Hospital of Chicago
Participant flow
Recruitment details
Youth ages 14-19 years were recruited through social media advertisements.
Pre-assignment details
Participants completed baseline screening assessments, including the Adverse Childhood Experiences (ACE) questionnaire. Participants were stratified by ACE score and then assigned to either the intervention group or the waitlist control group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 17.5 Years STANDARD_DEVIATION 0.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian or Asian American | 5 Participants |
| Race/Ethnicity, Customized Bi- or Multiracial | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Latino/a/x/e | 4 Participants |
| Race/Ethnicity, Customized Middle Eastern and/or North African | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 12 Participants |
| Sex/Gender, Customized Genderqueer or genderfluid | 1 Participants |
| Sex/Gender, Customized Man | 8 Participants |
| Sex/Gender, Customized Questioning or unsure | 4 Participants |
| Sex/Gender, Customized Woman | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 14 |
| other Total, other adverse events | 0 / 22 | 0 / 14 |
| serious Total, serious adverse events | 0 / 22 | 0 / 14 |
Outcome results
None listed