Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- CEDARS Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Wait-list control, no masking
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents ages 13-20
- •Adolescents able to speak and understand English fluently
- •Adolescents with reliable internet access (for virtual access to online modules)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CEDARS (Behavioral)
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.
干预措施: CEDARS (Behavioral)
结局指标
主要结局
CEDARS Intervention
时间窗: 8 Weeks
Participants will directly benefit from taking part in the interventions by learning and putting into practice new tools to reduce and manage their stress.
Baseline, Midpoint, and Post-Intervention Surveys
时间窗: 8 weeks
Participants will complete a baseline survey, a mid-point survey, and a post-intervention survey (after the completion of the last CEDARS online module).
Post-Intervention Follow-Up
时间窗: 4 weeks
There will be one follow-up survey with participants. The final survey will be 1 month post-intervention survey.
Feasibility: Percentage of Recruitment Target Enrollment Met
时间窗: Baseline
This measurement reflects the number of participants recruited compared to the recruitment target goal.
Feasibility:4 of 7 Intervention Modules Completed
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Depressive Symptoms(Baseline, Midpoint (Week 4), Endpoint (Week 8), and 1-month follow-up)
- Anxiety Symptoms(Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention)
- Positive Affect(Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention)
- Perceived Stress(Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention)
- Flourishing(Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention)
- Negative Affect(Baseline, Midpoint (4 weeks), Endpoint (8 weeks), 1 month post intervention)
- Resilient Coping(Baseline, Midpoint, Endpoint. 1 Month Post-Intervention)
研究者
Nia Heard-Garris
MD, MSc, FAAP
Ann & Robert H Lurie Children's Hospital of Chicago