NCT00650585

Brief Summary

The purpose of this study is to replicate a longitudinal evaluation of Project ALERT, a substance abuse prevention program that targets middle school students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

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

May 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 21, 2009

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

4.1 years

First QC Date

March 31, 2008

Results QC Date

July 27, 2009

Last Update Submit

June 5, 2013

Conditions

Keywords

smokingalcoholpreventionprevention & control

Outcome Measures

Primary Outcomes (8)

  • Self-reported 30-day Use of Alcohol

    Students completed an 81-item self-report questionnaire. They were asked on how many days they had used alcohol in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.

    measured approximately 30 days after intervention completed

  • Self-reported 30-day Use of Cigarettes

    Students completed an 81-item self-report questionnaire. They were asked on how many days they had smoked cigarettes in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.

    measured approximately 30 days after intervention completed

  • Self-reported 30-day Marijuana Use

    Students completed an 81-item self-report questionnaire. They were asked on how many days they had used marijuana in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.

    measured approximately 30 days after intervention completed

  • Self-reported 30-day Inhalant Use

    Students completed an 81-item self-report questionnaire. They were asked on how many days they had used inhalants in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.

    measured approximately 30 days after intervention completed

  • Self-reported Lifetime Alcohol Use

    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).

    measured approximately 30 days after intervention completed

  • Self-reported Lifetime Cigarette Use

    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).

    measured approximately 30 days after intervention completed

  • Self-reported Lifetime Marijuana Use

    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).

    measured approximately 30 days after intervention completed

  • Self-reported Lifetime Inhalant Use

    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).

    measured approximately 30 days after intervention completed

Study Arms (2)

Control group

NO INTERVENTION

Did not receive Project ALERT

Treatment group

EXPERIMENTAL

Received Project ALERT

Behavioral: Project ALERT

Interventions

Project ALERTBEHAVIORAL

Project ALERT (Adolescent Learning Experiences in Resistance Training) is a drug prevention curriculum designed for middle-school students (11 to 14 years old). The 11 lessons in the first year and 3 booster lessons in the second year focus on alcohol, tobacco, marijuana, and inhalants - the substances that adolescents are most likely to use. Project ALERT uses participatory activities and videos to help motivate youth to avoid drug use, to teach youth skills and strategies to resist peer pressures to use drugs, and to establish social norms against drug-use. More information about Project ALERT may be found at http://www.projectalert.best.org/.

Also known as: Adolescent Learning Experiences in Resistance Training
Treatment group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • schools with 6th-8th grades housed together on a common campus
  • schools with 6th grade student population of at least 100 students
  • schools with no current 6th, 7th, or 8th grade implementation of any drug prevention curriculum recognized as a model program by a federally-sponsored registry
  • all regular education students in the targeted grade must participate

You may not qualify if:

  • students in self-contained classrooms (i.e., special education classes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Institute for Research & Evaluation

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

  • Ringwalt CL, Clark HK, Hanley S, Shamblen SR, Flewelling RL. Project ALERT: a cluster randomized trial. Arch Pediatr Adolesc Med. 2009 Jul;163(7):625-32. doi: 10.1001/archpediatrics.2009.88.

Related Links

MeSH Terms

Conditions

Alcohol DrinkingSmokingMarijuana Smoking

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorMarijuana UseSmoking, Non-Tobacco Products

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Heddy Clark
Organization
PIRE

Study Officials

  • Chris L Ringwalt, DrPH

    Pacific Institute for Research & Evaluation

    PRINCIPAL INVESTIGATOR
  • Heddy K Clark, Ph.D.

    Pacific Institute for Research & Evaluation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 2, 2008

Study Start

May 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 13, 2013

Results First Posted

October 21, 2009

Record last verified: 2013-06

Locations