NCT00612482

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

January 29, 2008

Last Update Submit

March 11, 2011

Conditions

Keywords

Substance abuse

Outcome Measures

Primary Outcomes (1)

  • Lifetime, past 6 month and past 30 day use of substances

    Pre-intervention, immediate post-intervention, 6-7 month post-intervention

Secondary Outcomes (4)

  • Frequency and quantity of substance use

    Pre-intervention, immediate post-intervention, 6-7 months post-intervention

  • Knowledge about effects of substance use on the brain

    Pre-intervention, immediate post-intervention, 6-7 months post-intervention

  • Perceived risk of harm of substance use

    Pre-intervention, immediate post-intervention, 6-7 months post-intervention

  • Intention to use substances in the next 3 months

    Pre-intervention, immediate post-intervention, 6-7 months post-intervention

Study Arms (2)

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.

Other: drug prevention curriculum

Interventions

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

2

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • No parental permission to participate
  • Unable to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Sion Kim Harris, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 11, 2008

Study Start

December 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations