Official Title: “Youth Substance Use Prevention/Reduction Through Science-Based Drug Abuse Education: A High School Pilot Study”

Our primary goal is to conduct a pilot study of the effects of a new potential strategy for youth substance abuse prevention - science-based drug education integrated into the high school science curriculum. Through this pilot study we propose to: (1) demonstrate that this new strategy shows promise, and (2) estimate the effect size for the intervention.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: January 2008

NIDA, in recent years, has put resources into summarizing and synthesizing cutting-edge medical and basic science research discoveries about the short-term and long-term effects of drug use on the developing brain. One outcome of this results was the production of a science-based drug education program entitled "The Brain: Understanding Neurobiology Through the Study of Addiction." This is a 5-lesson module for high school science classes that teaches about brain structure and function, how drugs affect and change the biology and chemistry of the brain, how addiction occurs in the brain, and that addiction is a chronic, recurring disease. However, the effect of receipt of this program on students' substance use knowledge, attitudes, perceived risk of harm, and behavior has not been systematically evaluated to date.

The specific aims of this project are:

1. To evaluate the effects of receipt of the curriculum on specific cognitive contributors to substance use including a)students' knowledge about the short- and long-term effects of substance use on the brain; b)perceived risk of harm from substance use; and c)intention to use substances in the next 3 months.

2. To evaluate the effects of the intervention on actual substance use behavior. We hypothesize that the effectiveness of this approach may be modified by the students' level of prior and current substance use, with the effect being stronger among those who have not already initiated use, or among those who have very low use. Therefore, we will specifically examine whether the intervention a)prevents substance use initiation among students who had no previous use, b)stops use among students with low lifetime use, and c) reduces use among those with higher levels of use.

Intervention(s) in this Clinical Trial

• Other: drug prevention curriculum
  • Participants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Participants in the "no intervention" condition will receive the usual high school science curriculum.
• Experimental: 2
  • Participants in the "experimental" arm will receive the 5-lesson, science-based substance abuse prevention curriculum in their science classes.

Primary Measures

• Lifetime, past 6 month and past 30 day use of substances
  • Time Frame: Pre-intervention, immediate post-intervention, 6-7 month post-intervention
    Safety Issue?: No

Secondary Measures

• Frequency and quantity of substance use
  • Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
    Safety Issue?: No
• Knowledge about effects of substance use on the brain
  • Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
    Safety Issue?: No
• Perceived risk of harm of substance use
  • Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
    Safety Issue?: No
• Intention to use substances in the next 3 months
  • Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
    Safety Issue?: No

Inclusion Criteria:

• Student in 9th/10th/11th grade science classes at Fenway High School at start of study or student in 11th grade science classes at Boston Arts Academy at start of study
• Parental permission to participate

Exclusion Criteria:

• No parental permission to participate
• Unable to read English

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 14 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Children's Hospital Boston

Overall Clinical Trial Officials and Contacts

Sion Kim Harris, PhD Principal Investigator Children's Hospital Boston  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612482

Study ID Number: 06120537

ClinicalTrials.gov Identifier: NCT00612482

Health Authority: United States: Institutional Review Board

Web page of the Center for Adolescent Substance Abuse Research