SafERteens M-Coach

Not Applicable

Completed

• Conditions: Alcohol Drinking; Violence
• Interventions: Behavioral: Step 1 Treatment BI+HC; Behavioral: Step 2 Treatment Responders; Behavioral: Step 1 Treatment BI+TM; Behavioral: Step 2 Treatment Non-Responders

• Registration Number: NCT03344666
• Lead Sponsor: University of Michigan

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2018-05-01
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
First Treatment	Step 1 Treatment BI+TM	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.
Second Treatment for Responders and Non-Responders	Step 2 Treatment 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.
First Treatment	Step 1 Treatment BI+HC	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.
Second Treatment for Responders and Non-Responders	Step 2 Treatment 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.

Primary Outcome Measures

Name	Time	Method
Change in Alcohol Consumption	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Alcohol Consequences	4 months and 8 months post baseline	Alcohol related consequences will be measured using the Young Adult Alcohol Consequences Questionnaire (YAACQ). This study will use a 24-item scale with the following responses (and values): 0 = None; 1. = 1-2 times; 2. = 3-5 times; 3. = More than 5 times; The responses will be summed for a total score.
Change in Violence Consequences	4 months and 8 months post baseline	Violence related consequences will be assessed using 13 items with following responses (and values): 0 = None; 1. = 1-2 times; 2. = 3-5 times; 3. = More than 5 times; These items will assess consequences such as injury, arrest, trouble at school or work, arguments or trouble getting along with friends and/or family members, feeling guilty, unable to stop/desire to fight, and worry or revenge as a result of participant's fighting. Responses are summed to create a total score.

Trial Locations

Locations (4)

Hurley Medical Center - Emergency Department; 🇺🇸 Flint, Michigan, United States

Covenant Healthcare Emergency Care Center; 🇺🇸 Saginaw, Michigan, United States

Ascension St. John Hospital - Emergency Department; 🇺🇸 Detroit, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States