SafERteens M-Coach

  • STATUS
    Recruiting
  • End date
    Jul 19, 2023
  • participants needed
    700
  • sponsor
    University of Michigan
Updated on 7 October 2022
step 2

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.

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.

Details
Condition Alcohol Drinking, Violence
Treatment Step 1 Treatment BI+HC, Step 1 Treatment BI+TM, Step 2 Treatment Responders, Step 2 Treatment Non-Responders
Clinical Study IdentifierNCT03344666
SponsorUniversity of Michigan
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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