Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Change in Alcohol Consumption
研究概览
简要总结
This study will use a SMART (Sequential, Multiple Assignment Randomized Trial) design to optimize adaptive interventions (AIs) for adolescents reporting alcohol misuse and violent behaviors. The study will test the efficacy of state-of-the-art adaptive intervention delivery approaches (text messaging, remote therapy) for reducing alcohol use and violent behaviors among urban teens. Given the morbidly/mortality associated with alcohol use and violence, this study will have significant impact by using a SMART design to identify the optimal intervention strategy to produce and sustain outcomes among at-risk youth.
详细描述
The specific aims are to: 1) Compare the efficacy of adaptive interventions (AIs) that begin with BI+TM (brief intervention + text messaging) vs. BI+HC (brief intervention + remote health coach) on reducing alcohol misuse and violent behaviors among youth while in the Emergency Department (ED); and, 2) Identify the most efficacious second-stage strategy post-ED visit for those who initially respond and for those who do not. Specifically, 700 youth (ages 14-20) in the ED screening positive for alcohol use and violent behaviors will be randomly assigned to: BI+TM or BI+HC. After receiving the SafERteens BI in the ED, youth will complete weekly assessments over an 8 week period to tailor intervention content and measure mechanisms of change, with one month determination of participant response (e.g., binge drinking, violence). Responders in each arm will be re-randomized to continued condition (e.g., stay the course or maintenance), or reduced condition (e.g., stepped down). Non-responders will be re-randomized to continued condition (e.g., stay the course or maintenance), or intensified condition (e.g., stepped up). Follow-up assessments will take place at 4 and 8 months post-baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients age 14-20 years presenting to the ED for any reason(except exclusions as noted below)
- •past 4 month binge alcohol use and violent behaviors (i.e., physical aggression)
- •have a cell phone with texting capabilities and a cell phone plan for texting
排除标准
- •patients who do not understand English
- •patients deemed unable to provide informed consent due to mental incompetence, incarceration, or medically unstable (abnormal vital signs requiring urgent resuscitation) or
- •present for acute suicidal ideation or acute suicide attempt, child abuse, or sexual assault
研究组 & 干预措施
First Treatment
Participants will be randomized to first treatment to compare Brief Intervention + Health Coach (Step 1 Treatment BI+HC) to Brief Intervention + Text Messages (Step 1 Treatment BI+TM). Participants in the BI+HC will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks. Participants in the BI+TM will receive a BI in the ED, followed by daily TMs for 4 weeks.
干预措施: Step 1 Treatment BI+HC (Behavioral)
First Treatment
Participants will be randomized to first treatment to compare Brief Intervention + Health Coach (Step 1 Treatment BI+HC) to Brief Intervention + Text Messages (Step 1 Treatment BI+TM). Participants in the BI+HC will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks. Participants in the BI+TM will receive a BI in the ED, followed by daily TMs for 4 weeks.
干预措施: Step 1 Treatment BI+TM (Behavioral)
Second Treatment for Responders and Non-Responders
Beginning in week 5, all participants will be classified as Responders or Non-Responders (based on weekly assessments) and re-randomized.
Step 2 Treatment Responders: Responders will be randomized to either stay the course or be stepped down. Specifically, participants in the BI+HC will either continue to receive the HC or stepped down to receive a control brochure; participants in the BI+TM will either continue to receive the TM or stepped down to receive a control brochure.
Step 2 Treatment Non-Responders: Non-Responders will be randomized to either stay the course or be stepped up. Specifically, participants in the BI+HC will either continue to receive the HC or stepped up to receive a HC+; participants in the BI+TM will either continue to receive the TM or stepped up to receive HC.
干预措施: Step 2 Treatment Responders (Behavioral)
Second Treatment for Responders and Non-Responders
Beginning in week 5, all participants will be classified as Responders or Non-Responders (based on weekly assessments) and re-randomized.
Step 2 Treatment Responders: Responders will be randomized to either stay the course or be stepped down. Specifically, participants in the BI+HC will either continue to receive the HC or stepped down to receive a control brochure; participants in the BI+TM will either continue to receive the TM or stepped down to receive a control brochure.
Step 2 Treatment Non-Responders: Non-Responders will be randomized to either stay the course or be stepped up. Specifically, participants in the BI+HC will either continue to receive the HC or stepped up to receive a HC+; participants in the BI+TM will either continue to receive the TM or stepped up to receive HC.
干预措施: Step 2 Treatment Non-Responders (Behavioral)
结局指标
主要结局
Change in Alcohol Consumption
时间窗: 4 months and 8 months post baseline
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including binge drinking, with total consumption calculated.
Change in Physical Violence
时间窗: 4 months and 8 months post baseline
Physical violence will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and severity of violent behaviors (e.g. push, shove, slap, kick, punch, weapon/firearm use or carriage etc.), with total violence calculated weighted by severity.
次要结局
- Change in Alcohol Consequences(4 months and 8 months post baseline)
- Change in Violence Consequences(4 months and 8 months post baseline)
研究者
Maureen A Walton
Professor
University of Michigan