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Preventing Drug Abuse Among Hispanic Adolescents

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ClinicalTrials.gov Identifier: NCT02375516
Recruitment Status : Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date  ICMJE February 25, 2014
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date July 21, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
Drug abuse [ Time Frame: 6 months ]
30-day drug use captured by the Youth Risk Behavior Survey
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
Self-efficacy [ Time Frame: 6 months ]
Likert-scaled self-efficacy to refuse drugs obtained by Self-Efficacy Scale for Children
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 24, 2015)
Refusal skills [ Time Frame: 6 months ]
Likert-scaled responses on Youth Friend Behavior Scale
 
Descriptive Information
Brief Title  ICMJE Preventing Drug Abuse Among Hispanic Adolescents
Official Title  ICMJE Drug Abuse Prevention Programming for Hispanic Adolescents
Brief Summary

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.

Detailed Description America's largest ethnic minority group, Hispanics are also a youthful population: one-third of Hispanic Americans are less than 18 years old. Unfortunately, young Hispanic Americans are an at-risk population more likely than their majority culture peers to drop out of school, become involved in the criminal justice system, fall prey to violence, and face lifelong economic problems. Hispanic youths are also at risk for early drug use and subsequent harmful use and abuse. As early as eighth grade and relative to their Black and White peers, Hispanic adolescents report higher rates of most harmful substances. Drug use continues to pose problems for Hispanic youths throughout adolescence and into adulthood.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Drug Abuse
Intervention  ICMJE Behavioral: 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. 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Prevention Program
  • No Intervention: Control group
    Youths assigned to the control arm will receive no intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 22, 2016)
678
Original Actual Enrollment  ICMJE
 (submitted: February 24, 2015)
700
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 12 to 15 years old
  • Hispanic ethnicity

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375516
Other Study ID Numbers  ICMJE AAAK6105
R01DA031477 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Traci Schwinn, PhD Columbia University
PRS Account Columbia University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP