- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612482
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education: A High School Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Participants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lifetime, past 6 month and past 30 day use of substances
Time Frame: Pre-intervention, immediate post-intervention, 6-7 month post-intervention
|
Pre-intervention, immediate post-intervention, 6-7 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frequency and quantity of substance use
Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
|
Knowledge about effects of substance use on the brain
Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
|
Perceived risk of harm of substance use
Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
|
Intention to use substances in the next 3 months
Time Frame: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sion Kim Harris, PhD, Boston Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06120537
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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