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SafERteens M-Coach

Primary Purpose

Alcohol Drinking, Violence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Step 1 Treatment BI+HC
Step 1 Treatment BI+TM
Step 2 Treatment Responders
Step 2 Treatment Non-Responders
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan
  • Ascension St. John Hospital - Emergency Department
  • Hurley Medical Center - Emergency Department
  • Covenant Healthcare Emergency Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

First Treatment

Second Treatment for Responders and Non-Responders

Arm Description

Participants will be randomized to first treatment to compare Brief Intervention + Health Coach (Step 1 Treatment BI+HC) to Brief Intervention + Text Messages (Step 1 Treatment BI+TM). Participants in the BI+HC will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks. Participants in the BI+TM will receive a BI in the ED, followed by daily TMs for 4 weeks.

Beginning in week 5, all participants will be classified as Responders or Non-Responders (based on weekly assessments) and re-randomized. Step 2 Treatment Responders: Responders will be randomized to either stay the course or be stepped down. Specifically, participants in the BI+HC will either continue to receive the HC or stepped down to receive a control brochure; participants in the BI+TM will either continue to receive the TM or stepped down to receive a control brochure. Step 2 Treatment Non-Responders: Non-Responders will be randomized to either stay the course or be stepped up. Specifically, participants in the BI+HC will either continue to receive the HC or stepped up to receive a HC+; participants in the BI+TM will either continue to receive the TM or stepped up to receive HC.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 3, 2017
Last Updated
October 2, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03344666
Brief Title
SafERteens M-Coach
Official Title
Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Violence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First Treatment
Arm Type
Experimental
Arm Description
Participants will be randomized to first treatment to compare Brief Intervention + Health Coach (Step 1 Treatment BI+HC) to Brief Intervention + Text Messages (Step 1 Treatment BI+TM). Participants in the BI+HC will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks. Participants in the BI+TM will receive a BI in the ED, followed by daily TMs for 4 weeks.
Arm Title
Second Treatment for Responders and Non-Responders
Arm Type
Experimental
Arm Description
Beginning in week 5, all participants will be classified as Responders or Non-Responders (based on weekly assessments) and re-randomized. Step 2 Treatment Responders: Responders will be randomized to either stay the course or be stepped down. Specifically, participants in the BI+HC will either continue to receive the HC or stepped down to receive a control brochure; participants in the BI+TM will either continue to receive the TM or stepped down to receive a control brochure. Step 2 Treatment Non-Responders: Non-Responders will be randomized to either stay the course or be stepped up. Specifically, participants in the BI+HC will either continue to receive the HC or stepped up to receive a HC+; participants in the BI+TM will either continue to receive the TM or stepped up to receive HC.
Intervention Type
Behavioral
Intervention Name(s)
Step 1 Treatment BI+HC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Step 1 Treatment BI+TM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Step 2 Treatment Responders
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Step 2 Treatment Non-Responders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Alcohol Consumption
Description
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
Title
Change in Physical Violence
Description
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
Secondary Outcome Measure Information:
Title
Change in Alcohol Consequences
Description
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.
Time Frame
4 months and 8 months post baseline
Title
Change in Violence Consequences
Description
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.
Time Frame
4 months and 8 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen A Walton, MPH, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Ascension St. John Hospital - Emergency Department
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center - Emergency Department
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Covenant Healthcare Emergency Care Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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