NCT00682474

Brief Summary

The purpose of this study is to conduct a randomized controlled school-based trial to evaluate the effectiveness of a four-session school nurse-delivered smoking cessation intervention in increasing abstinence rates among high school students who smoke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,058

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

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

September 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 19, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

May 20, 2008

Last Update Submit

August 18, 2011

Conditions

Cigarette SmokingNicotine Dependence

Keywords

Cigarette smokingNicotine dependenceAdolescentsYouthSchool healthRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.

    3 months and 1 year post baseline

Secondary Outcomes (1)

  • Reduction in number of cigarettes and days smoked

    3 months and 1 year post baseline

Study Arms (2)

CI

EXPERIMENTAL

Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12

Behavioral: Counseling Intervention

II

ACTIVE COMPARATOR

Attention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12

Behavioral: Information Intervention

Interventions

Counseling InterventionBEHAVIORAL

Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12

Also known as: Calling It Quits
CI
Information InterventionBEHAVIORAL

Attention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12

II

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • enrolled in grades 9-12
  • report smoking at least one puff of a cigarette in the past 30 days
  • willingness to participate in a smoking cessation intervention study
  • able to speak and read English
  • able to complete the baseline questionnaire independently, indicating ability to complete study assessments and protocols
  • intending to remain enrolled in the school for the remainder of the school year
  • willing to provide contact information for the next 12 months

You may not qualify if:

  • unwilling/unable to provide informed assent
  • planning to move out of the area in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • Pbert L, Druker S, DiFranza JR, Gorak D, Reed G, Magner R, Sheetz AH, Osganian S. Effectiveness of a school nurse-delivered smoking-cessation intervention for adolescents. Pediatrics. 2011 Nov;128(5):926-36. doi: 10.1542/peds.2011-0520. Epub 2011 Oct 17.

    PMID: 22007015DERIVED

MeSH Terms

Conditions

Cigarette SmokingTobacco Use Disorder

Interventions

Counseling

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lori Pbert, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

September 1, 2006

Primary Completion

June 1, 2009

Study Completion

February 1, 2010

Last Updated

August 19, 2011

Record last verified: 2011-08

Locations

US(1)