Substance AbusePhase 1NCT00612482
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education
A Phase 1 study testing drug prevention curriculum in people with Substance Abuse, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- drug prevention curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- No parental permission to participate
- Unable to read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- drug prevention curriculum
- Keywords
- Substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug prevention curriculumOther
Participants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Participants in the "no intervention" condition will receive the usual high school science curriculum. |
| 2 | Experimental | Participants in the "experimental" arm will receive the 5-lesson, science-based substance abuse prevention curriculum in their science classes. Receives: Other: drug prevention curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifetime, past 6 month and past 30 day use of substances
Measured: Pre-intervention, immediate post-intervention, 6-7 month post-intervention
Secondary outcomes (4)
Frequency and quantity of substance use
Measured: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Knowledge about effects of substance use on the brain
Measured: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Perceived risk of harm of substance use
Measured: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Intention to use substances in the next 3 months
Measured: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startDec 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Public Schools
- Investigators
- Sion Kim Harris, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612482
- Sponsor's protocol ID
- 06120537
- Status last verified
- Mar 2011
- First submitted
- 29 Jan 2008
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education: A High School Pilot Study
- ClinicalTrials.gov ID
- NCT00612482
- Acronym / sponsor ID
- 06120537
- Conditions
- Substance Abuse
- Keywords
- Substance abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Boston Public Schools
- Study start
- Dec 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Participants in the "no intervention" condition will receive the usual high school science curriculum. |
| 2 | Experimental | Other: drug prevention curriculumParticipants in the "experimental" arm will receive the 5-lesson, science-based substance abuse prevention curriculum in their science classes. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- No parental permission to participate
- Unable to read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug prevention curriculumParticipants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes. | Other | 2 |
Primary outcome
Lifetime, past 6 month and past 30 day use of substances
Time frame: Pre-intervention, immediate post-intervention, 6-7 month post-intervention
4 secondary outcomes
Frequency and quantity of substance use
Time frame: 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
Perceived risk of harm of substance use
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
- Web page of the Center for Adolescent Substance Abuse ResearchLink provided by the sponsor.
Related trials for Substance Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sion Kim Harris, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing drug prevention curriculum in people with Substance Abuse, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2011.