NCT01164306

Brief Summary

The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:

  1. 1.preventing tobacco initiation in youth
  2. 2.promoting anti-tobacco socialization in the home
  3. 3.decreasing environmental tobacco smoke exposure in children
  4. 4.promoting successful cessation in parent/guardian smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
688

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

4.7 years

First QC Date

May 12, 2010

Last Update Submit

January 29, 2015

Conditions

Tobacco PreventionEnvironmental Tobacco Smoke ExposureTobacco Cessation

Keywords

LifeSkills TrainingTobacco preventionTobacco cessationHealthy lifestylesTobacco control

Outcome Measures

Primary Outcomes (3)

  • Primary prevention of tobacco use in youth

    Self-report and salivary cotinine is assessed to measure this outcome

    Baseline

  • Primary prevention of tobacco use in youth

    Self-report and salivary cotinine is assessed to measure this outcome.

    Year 2

  • Primary prevention of tobacco use in youth

    Self-report and salivary cotinine is assessed to measure this outcome.

    Year 4

Secondary Outcomes (5)

  • Smoking cessation in parents/guardians

    3 months

  • Smoking cessation in parents/guardians

    6 months

  • Smoking cessation in parents/guardians

    Year 1

  • Smoking cessation in parents/guardians

    Year 2

  • Smoking cessation in parents/guardians

    Year 4

Study Arms (2)

LifeSkills training

EXPERIMENTAL
Behavioral: LifeSkills TrainingBehavioral: NRT and Motivational Interviewing (MI)

Healthy Lifestyle Behaviors

ACTIVE COMPARATOR
Behavioral: Healthy Lifestyle Behavior Choices

Interventions

LifeSkills TrainingBEHAVIORAL

LifeSkills Training (Botvin's) is an evidenced based substance abuse prevention program for elementary school students to learn skills to resist tobacco, alcohol, drug abuse, and violence. Parent LifeSkills will also be utilized. Parents are provided a parent manual and DVD to use at home with their child to reinforce what they are taught in school-based LifeSkills sessions.

Also known as: LifeSkills Training (Botvin's)
LifeSkills training
Healthy Lifestyle Behavior ChoicesBEHAVIORAL

The healthy lifestyle behavior choices curriculum augments the state health curriculum in the assigned study schools. Parents will also be given health related information by mail to parallel the information students receive in school health classes.

Also known as: Healthy lifestyle behaviors
Healthy Lifestyle Behaviors
NRT and Motivational Interviewing (MI)BEHAVIORAL

For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.

Also known as: NRT is Nicotine Replacement Therapy, MI is Motivational Interviewing
LifeSkills training

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • child being of African-American ethnicity
  • in a 4th grade classroom of randomized schools
  • parent or guardian that 4th grade child resides with at least 50% of the time
  • have access to a telephone or mobile phone

You may not qualify if:

  • not being a child of African-American ethnicity
  • not being a parent or guardian that an eligible child lives with at least 50% of the time
  • not having access to a telephone or cell phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

  • Caldwell AL, Tingen MS, Nguyen JT, Andrews JO, Heath J, Waller JL, Treiber FA. Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. Pediatrics. 2018 Jan;141(Suppl 1):S96-S106. doi: 10.1542/peds.2017-1026M.

    PMID: 29292310DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Nicotine Replacement TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Martha S Tingen, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2010

First Posted

July 16, 2010

Study Start

September 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

US(1)