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SafERteens M-Coach

Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03344666
Enrollment
400
Registered
2017-11-17
Start date
2018-05-01
Completion date
2023-07-25
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Violence

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.

Interventions

BEHAVIORALStep 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.

BEHAVIORALStep 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.

BEHAVIORALStep 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.

BEHAVIORALStep 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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Alcohol Consumption4 months and 8 months post baselineAlcohol 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 Violence4 months and 8 months post baselinePhysical 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

MeasureTime frameDescription
Change in Alcohol Consequences4 months and 8 months post baselineAlcohol 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 Consequences4 months and 8 months post baselineViolence 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026