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Preventing Drug Abuse Among Hispanic Adolescents

Primary Purpose

Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention Program
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Abuse focused on measuring Drug abuse

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 12 to 15 years old
  • Hispanic ethnicity

Exclusion Criteria:

  • None

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevention Program

Control group

Arm Description

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.

Youths assigned to the control arm will receive no intervention.

Outcomes

Primary Outcome Measures

Change in average number of drug abuse instances
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2014
Last Updated
July 30, 2021
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02375516
Brief Title
Preventing Drug Abuse Among Hispanic Adolescents
Official Title
Drug Abuse Prevention Programming for Hispanic Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
April 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
Drug abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
678 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Youths assigned to the control arm will receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in average number of drug abuse instances
Description
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.
Time Frame
Baseline, Post-intervention, Year 1, Year 2, Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 12 to 15 years old Hispanic ethnicity Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Traci Schwinn, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26500421
Citation
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.
Results Reference
result
PubMed Identifier
27648525
Citation
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.
Results Reference
result

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Preventing Drug Abuse Among Hispanic Adolescents

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