NCT03344666

SafERteens M-Coach

Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 14 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Alcohol Drinking
• Violence

Interventions

Type	Name	Description
BEHAVIORAL	Step 1 Treatment BI+HC	Participants in the Brief intervention + Health Coach (BI+HC) will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks, which will occur by phone or in person. During sessions, the HC will review the prior week's progress, and discuss goals and plans for the following week.
BEHAVIORAL	Step 1 Treatment BI+TM	Participants in the Brief intervention + Text messages (BI+TM) will receive a BI in the ED, followed by daily TMs for 4 weeks. TM's are tailored based on weekly surveys and focus on motives for alcohol and violence and strategies to reduce involvement.
BEHAVIORAL	Step 2 Treatment Responders	Participants in the BI+HC assigned to stay the course (e.g., continue to receive the HC) will have 4 more weekly sessions with the HC. Participants in the BI+TM assigned to stay the course (e.g., continue to receive the TM) will receive 4 more weeks of TM. Participants in the BI+HC or BI+TM assigned to stepped down control will receive a brochure containing community resources.
BEHAVIORAL	Step 2 Treatment Non-Responders	Participants in the BI+HC assigned to be stepped up will receive HC+, which will consist of weekly sessions as well as on daily TMs from the HC. Participants in the BI+HC assigned to stay the course (e.g., continue to receive the HC) will have 4 more weekly sessions with the HC. Participants in the BI+TM assigned to be stepped up will receive the HC, which consists of 4 weekly sessions with the HC. Participants in the BI+TM assigned to stay the course (e.g., continue to receive the TM) will receive 4 more weeks of TM.

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2017-11-17
• Last updated: 2024-07-05

Locations

4 sites across 1 country: United States