SafERteens M-Coach

NCT03344666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-07-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • University of Michigan

    lead OTHER

Principal Investigators

  • Maureen A Walton, MPH, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
14 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2023-07-25
Completion
2023-07-25

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344666 on ClinicalTrials.gov