SafERteens M-Coach

University of Michigan

Status: Completed

Conditions: Violence; Alcohol Drinking

Treatments: Behavioral: Step 2 Treatment Responders; Behavioral: Step 2 Treatment Non-Responders; Behavioral: Step 1 Treatment BI+TM; Behavioral: Step 1 Treatment BI+HC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03344666

HUM00109156

R01AA024755 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 14 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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400 participants in 2 patient groups

First Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Step 1 Treatment BI+TM

Behavioral: Step 1 Treatment BI+HC

Second Treatment for Responders and Non-Responders

Experimental group

Description:

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.

Treatment:

Behavioral: Step 2 Treatment Non-Responders

Behavioral: Step 2 Treatment Responders