A Technology-Augmented Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Emergency Department Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
研究概览
简要总结
The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
详细描述
Peer violence and depressive symptoms have mutual, reinforcing negative impacts on teens' emotional and behavioral regulation strategies.
The emergency department (ED) is the primary source of care for many high-risk teens. It provides an opportunity to initiate preventive interventions, to complement existing mental health treatment or to stand alone for those who may lack access to formal care. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.
The purpose of this study is to expand on the PI's pilot randomized controlled trial (RCT) of iDOVE (K23 MH095866; PI: Ranney) by testing the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens). The investigators will use a 2x2 factorial design to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.
Participants will be identified in the course of usual clinical care in the ED. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to one of four groups: Brief ED Intervention (BI) + Text; BI + No Text; No BI + Text; or No BI + No Text. Youth in the Text arm who show no signal of improvement at 7 days, per daily self-reported mood ratings, will be re-randomized to additional "LiveText" (once-weekly real-time micro-counseling via text) or to continue with standard, automated Text intervention curriculum.
At baseline and follow-ups at 2 months, 4 months, and 8 months, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •presenting to the emergency department for routine care
- •reporting past-year physical violence (using a modified version of The Revised Conflict Tactics Scales (CTS-2) score ≥1), as identified on a brief screen administered in the ED
- •reporting past 2-week mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ-9) score 5-19), as identified on a brief screen administered in the ED
- •Accompanied by a parent/guardian who is present and able to consent
- •Possession of a cell phone with text-messaging capability
排除标准
- •Chief complaint of suicidality, psychosis, sexual assault, or child abuse
- •In police or child protective services' custody (as per state law)
- •Unable to assent
- •In need of emergency psychiatric care
研究组 & 干预措施
+ Brief ED Intervention (BI), + Text
Participants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills).
干预措施: + Brief ED Intervention (BI) (Behavioral)
+ Brief ED Intervention (BI), + Text
Participants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills).
干预措施: + Text (Behavioral)
+ Brief ED Intervention (BI), no Text
Participants receive the Brief ED Intervention component only (which is a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant).
干预措施: + Brief ED Intervention (BI) (Behavioral)
No Brief ED Intervention (BI), + Text
Participants receive the Text Message Intervention component only (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Participants receive a brochure containing online and community resources for violence and depression prevention instead of the Brief ED Intervention component.
干预措施: + Text (Behavioral)
No Brief ED Intervention (BI), no Text
Participants receive neither the Brief ED Intervention component, nor the Text Message Intervention component. Participants receive a brochure containing online and community resources for violence and depression prevention, instead of the Brief ED Intervention component.
结局指标
主要结局
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
时间窗: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Change from enrollment depressive symptoms (score is summed based on symptom group, range 0 - 80)
Conflict Tactics Scale-2, physical subset (CTS-2)
时间窗: Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment
Change from enrollment physical peer violence (score is summed, range 0 - 56)
次要结局
- Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)(Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment)
- Change in ED Visits for Assault-Related Injury(12 months before enrollment and 12 months after enrollment)
- Illinois Bully Scale (IBS)(Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment)
- Student School Survey(Enrollment, 2 months post-enrollment, 4 months post-enrollment, 8 months post-enrollment)