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Step 2 Treatment Non-Responders for Domestic Violence

N/A

Waitlist Available

Led By Maureen A Walton, MPH, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months and 8 months post baseline

Awards & highlights

Study Summary

This trial will use a SMART design to figure out the best way to use text messaging and remote therapy to reduce alcohol use and violence among urban teens.

Eligible Conditions

Domestic Violence
Alcohol Consumption

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months and 8 months post baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months and 8 months post baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months and 8 months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Alcohol Consumption

Change in Physical Violence

Secondary outcome measures

Change in Alcohol Consequences

Change in Violence Consequences

Trial Design

2Treatment groups

Experimental Treatment

Group I: Second Treatment for Responders and Non-RespondersExperimental Treatment2 Interventions

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.

Group II: First TreatmentExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Step 2 Treatment Non-Responders

2018

N/A

~400

Step 1 Treatment BI+HC

2018

N/A

~400

Step 1 Treatment BI+TM

2018

N/A

~400

Step 2 Treatment Responders

2018

N/A

~400

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

806 Previous Clinical Trials

1,157,649 Total Patients Enrolled

University of MichiganLead Sponsor

1,799 Previous Clinical Trials

6,378,239 Total Patients Enrolled

Maureen A Walton, MPH, PhDPrincipal Investigator - University of Michigan

University of Michigan

1 Previous Clinical Trials

955 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this experiment?

"According to the records on clinicaltrials.gov, this research endeavour is no longer recruiting participants as it was last updated in October of 2022. However, there are still 257 other studies currently searching for individuals to partake in their trials."

Answered by AI

Is the enrollment criterion for this experiment restricted to individuals under 55 years of age?

"As per the eligibility requirements, this study only allows adolescents between 14 and 20 years of age to participate."

Answered by AI

Is it possible for me to participate in this clinical experiment?

"This trial recruits 400 adolescents aged 14-20 who are actively engaging in alcohol consumption. In addition to these criteria, each patient must have a mobile device with texting capabilities and an active phone plan that allows for the sending of text messages. Plus, those involved cannot be excluded due to violent behaviour or past 4 month binge drinking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SafERteens M-Coach

Maureen A Walton 2018. "SafERteens M-Coach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03344666.