Prevention of Substance Use in Youth in Ukraine

NCT02347644 | Completed

• 1 other identifier: D43TW009310
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 2

Brief Summary

The objective of this study is to explore the efficacy of brief motivational interventions (BMIs) for treatment of youth with alcohol and other drug problems after at least 3 months. The results of previous studies indicate that brief interventions for unhealthy alcohol use have been shown to be effective in primary care settings, with most studies focusing on adults and few studies focusing on youth. To date, no BMI studies have been conducted in the Ukraine among youth with alcohol or other drug use. Of particular concern are emerging adults ages 18-25 who may be at particularly high risk for alcohol problems given historical events related to the fall of the Soviet Union and the subsequent economic down turn. This study will evaluate the efficacy of BMI by comparing BMI and no BMI conditions among two samples of youth screening positive on the prescreen survey for risky drinking. The subject pool will come from the Psychoneurological Department: the first location is located in the Railway Clinical Hospital, its clinical base, and the second in classes in the department at Kiev National Medical University. The total sample of 120 will be broken down to 1.) 60 patients from Railway Clinical Hospital; and 2.) 60 students from Kiev National Medical University. Participants will be stratified by recruitment site and randomized to condition: BMI and control, with follow-up assessment at 3 months. In addition to being the first of study to evaluate the efficacy of BMI on substance use problems among youth in Ukraine, this study will examine BMI intervention processes in relation to alcohol and other drug outcomes. Findings will inform research and clinical practice to enhance early identification and prevention of problematic alcohol use trajectories among emerging adults

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Alcohol consumption at Time Two of Follow-up Survey

  AUDIT-C total score, Q X F, Abstinence as defined as a day without any alcohol or drug use.

  Three Months

Study Arms (2)

Brief Motivational Interview

EXPERIMENTAL

Given a brief motivational interview encouraging reduced use of alcohol and drugs.

Behavioral: Brief Motivational Interview

Youth Control Group

NO INTERVENTION

Given a brochure with all available organizations in the community for help with alcohol and drug problems.

Interventions

Brief Motivational Interview BEHAVIORAL

Motivational interviewing is a technique which aims to be both non-judgmental and non-confrontational. Its success depends largely on the presentation of objective feedback based on information provided by an individual. The technique involves acknowledgement that individuals who attend a counselling session, assessment or prevention program may be at different levels of readiness to change their alcohol consumption patterns, including: * No perception of any alcohol consumption problem * Realization of alcohol consumption problem with no corresponding action

Brief Motivational Interview

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• have prescreen survey results indicating alcohol and drug abuse risk or have diagnosis of alcohol or substance use dependence according to ICD-10
• Between the ages of 18-25
• speaks and writes Ukrainian or Russian
• provide informed consent to participate

Sponsors & Collaborators

• University of Michigan: lead
• National Medical University, Ukraine: collaborator

Study Sites (2)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Kyiv National Medical University

Kyiv, 01601, Ukraine

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Maureen Walton, MPH, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

UA (1); US (1)