NCT Number: NCT03344666
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.
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Notify Me14 year–20 year
All sexes
Interventional
Not applicable
University of Michigan, Ann Arbor, Michigan, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: 4 months and 8 months post baseline
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.
Time frame: 4 months and 8 months post baseline
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.
Time frame: 4 months and 8 months post baseline
Alcohol 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
The responses will be summed for a total score.
Time frame: 4 months and 8 months post baseline
Violence related consequences will be assessed using 13 items with following responses (and values):
0 = None
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.
University of Michigan
Other
Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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