Preventing Drug Abuse Among Hispanic Adolescents

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

Tracking Information

• First Submitted Date: February 25, 2014
• First Posted Date: March 2, 2015
• Last Update Posted Date: July 21, 2020
• Study Start Date: September 2012
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: February 24, 2015)

Drug abuse [ Time Frame: 6 months ]

30-day drug use captured by the Youth Risk Behavior Survey

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Preventing Drug Abuse Among Hispanic Adolescents
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Drug Abuse

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.

Study Arms

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 22, 2016): 678
• Original Actual Enrollment (submitted: February 24, 2015): 700
• Estimated Study Completion Date: June 2021
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 12 to 15 years old
• Hispanic ethnicity

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 15 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02375516
• Other Study ID Numbers: AAAK6105; R01DA031477 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Columbia University
• Study Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Traci Schwinn, PhD; Columbia University

• PRS Account: Columbia University
• Verification Date: July 2020