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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02375516
Other study ID # AAAK6105
Secondary ID R01DA031477
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date April 7, 2021

Study information

Verified date July 2021
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 678
Est. completion date April 7, 2021
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 15 Years
Eligibility Inclusion Criteria: - 12 to 15 years old - Hispanic ethnicity Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2014 Jul 1. — View 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. Epub 2016 Sep 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, Post-intervention, Year 1, Year 2, Year 3
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