Incentive-based Intervention for Smoking Cessation and Pr... | NCT01173835

Studies
Incentive-based Intervention for Smoking Cessation and Prevention in High Schools

NCT01173835

Sponsor

Yale University

Status

Completed

Last Update Posted

Jul 4, 2012Estimated

Enrollment

1,651Actual

Phase

Phase 1

Conditions

Tobacco Prevention and Cessation

Interventions

Incentives for being tobacco free

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA026450	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jul 29, 2010

First Submission Date that Met QC Criteria

Jul 30, 2010

First Posted Date

Aug 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2012

Last Update Posted Date

Jul 4, 2012Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to design an incentive-based intervention to motivate a tobacco-free lifestyle among high school students and to pilot the intervention in the first academic year in two schools (CT and NY) and examine feasibility and acceptability. Preliminary efficacy of the intervention will be assessed by implementing it in two new schools (CT and NY) in the second academic year and determine an effect size estimate for a larger trial.

The study is intended to assess the number of students joining the program and pledging to be smoke-free and to examine changes in tobacco use rates and attitudes following intervention exposure. We hypothesize that the schools will have lower rates of tobacco use and improvement in attitudes, norms and behavioral control over tobacco use after participating in the program.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,651Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Incentives for being tobacco free	Behavioral	Students who join the program will be entered into regularly scheduled drawings throughout the school year to earn incentives for being tobacco free.		Incentive-based program Tobacco Free and Win Contingency Management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of students who join the tobacco free program		at the end of each academic year

Secondary Outcomes

Measure	Description	Time Frame
Change in tobacco use rates and attitudes following the intervention exposure		at the end of each academic year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

high school student at school that is invited to participate

Exclusion Criteria:

no exclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suchitra Krishnan-Sarin, Ph.D.	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMHC, Substance Abuse Center		New Haven	Connecticut	06519	United States

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072278	Forkhead Box Protein M1

Ancestor Terms

ID	Term
D051858	Forkhead Transcription Factors
D051540	Winged-Helix Transcription Factors
D004268	DNA-Binding Proteins
D011506	Proteins

Browse Leaves

Not provided

Browse Branches

Not provided