Prevention of Substance Use in Youth in Ukraine

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT02347644
• Date of registration: 21/01/2015
• Prospective Registration: No
• Primary sponsor: University of Michigan
• Public title: Prevention of Substance Use in Youth in Ukraine PSUUKR
• Scientific title: Pilot Study of Prevention of Alcohol and Other Drug Use Using Motivational Interviewing Among Youth in Ukraine
• Date of first enrolment: January 2015
• Target sample size: 121
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02347644
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Ukraine, United States

Contacts

• Name: Maureen Walton, MPH, PhD
• Affiliation: University of Michigan

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 25 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Substance Use Disorders

Intervention(s)

Behavioral: Brief Motivational Interview

Primary Outcome(s)

Alcohol consumption at Time Two of Follow-up Survey [Time Frame: Three Months]

Secondary ID(s)

D43TW009310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Medical University, Ukraine