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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00612482
Other study ID # 06120537
Secondary ID
Status Completed
Phase Phase 1
First received January 29, 2008
Last updated March 11, 2011
Start date December 2006
Est. completion date January 2008

Study information

Verified date March 2011
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 19 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Boston Boston Public Schools

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lifetime, past 6 month and past 30 day use of substances Pre-intervention, immediate post-intervention, 6-7 month post-intervention No
Secondary Frequency and quantity of substance use Pre-intervention, immediate post-intervention, 6-7 months post-intervention No
Secondary Knowledge about effects of substance use on the brain Pre-intervention, immediate post-intervention, 6-7 months post-intervention No
Secondary Perceived risk of harm of substance use Pre-intervention, immediate post-intervention, 6-7 months post-intervention No
Secondary Intention to use substances in the next 3 months Pre-intervention, immediate post-intervention, 6-7 months post-intervention No
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