- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375516
Preventing Drug Abuse Among Hispanic Adolescents
Drug Abuse Prevention Programming for Hispanic Adolescents
The planned research aims to delay the onset of drug use and reduce harmful use and abuse among Hispanic youths. The culturally-tailored prevention program will be delivered to youths by computer. Over 5 years, the program will be developed and tested in a randomized clinical trial. The intervention program will include 10 initial sessions, followed by annual booster sessions. Outcome measurements will involve baseline, post-intervention, and three annual follow-up data collections.
The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among participants assigned to receive the intervention. If proven to be efficacious, the program will be revised and disseminated nationally.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 12 to 15 years old
- Hispanic ethnicity
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Prevention Program
Youths in the intervention-arm will interact online with the initial intervention program between pretest and posttest measurement occasions and will interact with booster sessions subsequent to 1- and 2-year follow-up measurement occasions.
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Youths in the intervention-arm will interact online with the initial intervention program between pretest and posttest measurement occasions and will interact with booster sessions subsequent to 1- and 2-year follow-up measurement occasions.
Owing to the expense associated with developing a treatment-as-usual intervention for computer delivery in the control arm, youths assigned to the control arm will receive no intervention.
|
|
No Intervention: Control group
Youths assigned to the control arm will receive no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in average number of drug abuse instances
Time Frame: Baseline, Post-intervention, Year 1, Year 2, Year 3
|
Measures will ask participants to report, for the past 30 days, the number of: drinks of alcohol consumed, cigarettes smoked, puffs of marijuana, and times they consumed five or more drinks during one drinking occasion.
Participants will also report past 30-day use of: inhalants, ecstasy, club drugs, prescription drugs for recreational use, heroin, diet pills, and hallucinogens.
|
Baseline, Post-intervention, Year 1, Year 2, Year 3
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Traci Schwinn, PhD, Columbia University
Publications and helpful links
General Publications
- Schinke SP, Schwinn TM, Hursh HA. Preventing Drug Abuse Among Hispanic Adolescents: Developing a Responsive Intervention Approach. Res Soc Work Pract. 2015 Oct;25(7):794-800. doi: 10.1177/1049731514538103. Epub 2014 Jul 1.
- Schwinn TM, Schinke SP, Hopkins J, Thom B. Risk and protective factors associated with adolescent girls' substance use: Data from a nationwide Facebook sample. Subst Abus. 2016 Oct-Dec;37(4):564-570. doi: 10.1080/08897077.2016.1154495. Epub 2016 Sep 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAK6105
- R01DA031477 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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