Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02115


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

06120537


NCT ID:

NCT00612482


Secondary ID:


Study Acronym:


Brief Title:

Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education


Official Title:

Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education: A High School Pilot Study


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

14 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Boston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

225


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:December 2006
Completion Date:January 2008
Completion Type:Actual
Primary Completion Date:January 2008
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 11, 2011
First Received Date:January 29, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Intention to use substances in the next 3 months
Time Frame:Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Perceived risk of harm of substance use
Time Frame:Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Knowledge about effects of substance use on the brain
Time Frame:Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Frequency and quantity of substance use
Time Frame:Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Lifetime, past 6 month and past 30 day use of substances
Time Frame:Pre-intervention, immediate post-intervention, 6-7 month post-intervention
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:drug prevention curriculum
Description:Participants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes.
Arm Name:2

Study Arms

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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Boston
Agency Class:Other
Agency Type:Collaborator
Agency Name:Boston Public Schools

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.