Clinical trial NCT03344666: SafERteens M-Coach
Official title: Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Violence
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-11-17
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Alcohol Consumption
timeFrame: 4 months and 8 months post baseline
measure: Change in Physical Violence
timeFrame: 4 months and 8 months post baseline
Secondary outcomes:
measure: Change in Alcohol Consequences
timeFrame: 4 months and 8 months post baseline
measure: Change in Violence Consequences
timeFrame: 4 months and 8 months post baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital - Emergency Department
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center - Emergency Department
state: Michigan
city: Saginaw
country: United States
facility: Covenant Healthcare Emergency Care Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Maureen A Walton, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: