SafERteens M-Coach

NCT03344666 | Completed

• 2 other identifiers: HUM00109156R01AA024755
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Alcohol Drinking; Violence

Outcome Measures

Primary Outcomes (2)

• Change in Alcohol Consumption

  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.

  4 months and 8 months post baseline

• Change in Physical Violence

  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.

  4 months and 8 months post baseline

Secondary Outcomes (2)

• Change in Alcohol Consequences

  4 months and 8 months post baseline

• Change in Violence Consequences

  4 months and 8 months post baseline

Study Arms (2)

First Treatment

EXPERIMENTAL

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.

Behavioral: Step 1 Treatment BI+HC; Behavioral: Step 1 Treatment BI+TM

Second Treatment for Responders and Non-Responders

EXPERIMENTAL

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.

Behavioral: Step 2 Treatment Responders; Behavioral: Step 2 Treatment Non-Responders

Interventions

Step 1 Treatment BI+HC BEHAVIORAL

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.

First Treatment

Step 1 Treatment BI+TM BEHAVIORAL

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.

First Treatment

Step 2 Treatment Responders BEHAVIORAL

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.

Second Treatment for Responders and Non-Responders

Step 2 Treatment Non-Responders BEHAVIORAL

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.

Second Treatment for Responders and Non-Responders

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Ascension St. John Hospital - Emergency Department

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center - Emergency Department

Flint, Michigan, 48503, United States

Location

Covenant Healthcare Emergency Care Center

Saginaw, Michigan, 48602, United States

Location

Related Publications (1)

• Walton MA, Carter PM, Seewald L, Ngo Q, Battisti KA, Pearson C, Blow FC, Cunningham RM, Bourque C, Kidwell KM. Adaptive interventions for alcohol misuse and violent behaviors among adolescents and emerging adults in the emergency department: A sequential multiple assignment randomized controlled trial protocol. Contemp Clin Trials. 2023 Jul;130:107218. doi: 10.1016/j.cct.2023.107218. Epub 2023 May 5.

  PMID: 37148999 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Maureen A Walton, MPH, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 17, 2017
• Study Start: May 1, 2018
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)