SafERteens M-Coach

Alcohol Drinking Clinical Trial

Official title:

Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344666
• Other study ID #: HUM00109156
• Secondary ID: R01AA024755
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 25, 2023

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Violence

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Ascension St. John Hospital - Emergency Department	Detroit	Michigan
United States	Hurley Medical Center - Emergency Department	Flint	Michigan
United States	Covenant Healthcare Emergency Care Center	Saginaw	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol Consumption	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.	4 months and 8 months post baseline
Primary	Change in Physical Violence	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.	4 months and 8 months post baseline
Secondary	Change in Alcohol Consequences	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; = 1-2 times; = 3-5 times; = More than 5 times; The responses will be summed for a total score.	4 months and 8 months post baseline
Secondary	Change in Violence Consequences	Violence related consequences will be assessed using 13 items with following responses (and values): 0 = None; = 1-2 times; = 3-5 times; = 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.	4 months and 8 months post baseline