Substance Use Disorders Clinical Trial
— PSUUKROfficial title:
Pilot Study of Prevention of Alcohol and Other Drug Use Using Motivational Interviewing Among Youth in Ukraine
Verified date | December 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 121 |
Est. completion date | December 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 25 Years |
Eligibility |
Inclusion Criteria:Adults ages 18-25 able to provide informed consent: 1) adults
presenting to the Railway Clinic Hospital for a medical problems except for exclusion
criteria below and, 2) students of KNMU ages 18-25. Additional inclusion criteria for the
RCT is: - 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 Exclusion Criteria: 1) Adults classified as "psychotic patients" (who need special treatment and are not able to follow the requirements of the protocol); (2) adults deemed unable to provide informed consent by hospital personnel or research staff (e.g., intoxication, mental incompetence) and (3) adults with suicide attempts in their history or with suicidal thoughts in the past (because they present in high psychological distress requiring intensive attention and intervention by staff); When we ask our patients about suicidal thoughts and acts, and we will evaluate the suicidal risk for clinical referral and because it is an important inclusion criteria. the patient has a high suicidal risk, If we see that a participant has suicidal thoughts, suicidal attempts or suicidal risk according to the results of the scales, we will we will exclude him/her from the study; provide medical care, and phone numbers and addresses of help desk, but will not take financial responsibility for that care. 4.) We will also exclude pregnant women. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Ukraine | Kyiv National Medical University | Kyiv | |
United States | University of Michigan Health System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Medical University, Ukraine |
United States, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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