Tobacco PreventionNCT01164306
The Impact of a Tobacco Control Intervention in African-American Families
A study testing LifeSkills Training, Healthy Lifestyle Behavior Choices and NRT and Motivational Interviewing (MI) in people with Tobacco Prevention and Environmental Tobacco Smoke Exposure, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at: 1. preventing tobacco initiation in youth 2. promoting anti-tobacco socialization in the home 3. decreasing environmental tobacco smoke exposure in children 4. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Prevention, Environmental Tobacco Smoke Exposure, Tobacco Cessation
- What is being tested?
- LifeSkills Training, Healthy Lifestyle Behavior Choices and NRT and Motivational Interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
- preventing tobacco initiation in youth
- promoting anti-tobacco socialization in the home
- decreasing environmental tobacco smoke exposure in children
- promoting successful cessation in parent/guardian smokers.
Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.
Read the detailed description
All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.
Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).
- Being tested
- LifeSkills Training, Healthy Lifestyle Behavior Choices, NRT and Motivational Interviewing (MI)
- Keywords
- LifeSkills Training, Tobacco prevention, Tobacco cessation, Healthy lifestyles, Tobacco control
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeSkills TrainingBehavioural
Also called LifeSkills Training (Botvin's)
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.
Healthy Lifestyle Behavior ChoicesBehavioural
Also called Healthy lifestyle behaviors
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.
NRT and Motivational Interviewing (MI)Behavioural
Also called NRT is Nicotine Replacement Therapy, MI is Motivational Interviewing
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
| Study group | Role | What they receive |
|---|---|---|
| LifeSkills training | Experimental | Not described Receives: Behavioral: LifeSkills Training; Behavioral: NRT and Motivational Interviewing (MI) |
| Healthy Lifestyle Behaviors | Active comparator | Not described Receives: Behavioral: Healthy Lifestyle Behavior Choices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary prevention of tobacco use in youth
Self-report and salivary cotinine is assessed to measure this outcome
Measured: Baseline
Primary prevention of tobacco use in youth
Self-report and salivary cotinine is assessed to measure this outcome.
Measured: Year 2
Primary prevention of tobacco use in youth
Self-report and salivary cotinine is assessed to measure this outcome.
Measured: Year 4
Secondary outcomes (5)
Smoking cessation in parents/guardians
Measured: 3 months
Smoking cessation in parents/guardians
Measured: 6 months
Smoking cessation in parents/guardians
Measured: Year 1
Smoking cessation in parents/guardians
Measured: Year 2
Smoking cessation in parents/guardians
Measured: Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startSep 2007
- Primary completionMay 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Martha Tingen, Augusta University
- Investigators
- Martha S Tingen, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164306
- Sponsor's protocol ID
- R01CA118066
- Other IDs
- R01CA118066
- Status last verified
- Jan 2015
- First submitted
- 12 May 2010
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29292310
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Tobacco Control Intervention in African-American Families
- ClinicalTrials.gov ID
- NCT01164306
- Acronym / sponsor ID
- R01CA118066
- Keywords
- LifeSkills Training, Tobacco prevention, Tobacco cessation, Healthy lifestyles, Tobacco control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
- preventing tobacco initiation in youth
- promoting anti-tobacco socialization in the home
- decreasing environmental tobacco smoke exposure in children
- promoting successful cessation in parent/guardian smokers.
Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.
Detailed description
All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.
Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LifeSkills training | Experimental | Behavioral: LifeSkills Training, Behavioral: NRT and Motivational Interviewing (MI) |
| Healthy Lifestyle Behaviors | Active comparator | Behavioral: Healthy Lifestyle Behavior Choices |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeSkills TrainingAlso: LifeSkills Training (Botvin's)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. | Behavioural | LifeSkills training |
| Healthy Lifestyle Behavior ChoicesAlso: Healthy lifestyle behaviorsThe 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. | Behavioural | Healthy Lifestyle Behaviors |
| NRT and Motivational Interviewing (MI)Also: NRT is Nicotine Replacement Therapy, MI is Motivational InterviewingFor parent/guardian smokers who want to quit, NRT is offered in conjunction with MI. | Behavioural | LifeSkills training |
Primary outcome
Primary prevention of tobacco use in youth
Time frame: Baseline
Self-report and salivary cotinine is assessed to measure this outcome
Primary prevention of tobacco use in youth
Time frame: Year 2
Self-report and salivary cotinine is assessed to measure this outcome.
Primary prevention of tobacco use in youth
Time frame: Year 4
Self-report and salivary cotinine is assessed to measure this outcome.
5 secondary outcomes
Smoking cessation in parents/guardians
Time frame: 3 months
Smoking cessation in parents/guardians
Time frame: 6 months
Smoking cessation in parents/guardians
Time frame: Year 1
Smoking cessation in parents/guardians
Time frame: Year 2
Smoking cessation in parents/guardians
Time frame: Year 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Derived from this study: PubMed 29292310Caldwell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha S Tingen, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeSkills Training, Healthy Lifestyle Behavior Choices and NRT and Motivational Interviewing (MI) in people with Tobacco Prevention and Environmental Tobacco Smoke Exposure, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary prevention of tobacco use in youth (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01164306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.