SmokingNCT00056927
Anti-Smoking Program for Parents: Effects on Child Smoking
A study testing Anti-smoking Socialization Program in people with Smoking, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
The purpose of this study is to determine whether an anti-smoking program for parents who smoke will lower the odds that their children will start smoking. The study will evaluate an activity-based program for parents and their children. The program is home-based and uses the mail for program delivery. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Anti-smoking Socialization Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,007 participants
- Where
- No sites listed yet
- Study dates
- Sep 1997to Aug 2002
- 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
- Parents or guardians who smoke
- Have children in the 3rd grade
- Belong to participating school districts in North Carolina, South Carolina, or Colorado
Who cannot join
None listed.
About this study
Official title: Preventing Initiation of Smoking by Children
The purpose of this study is to determine whether an anti-smoking program for parents who smoke will lower the odds that their children will start smoking. The study will evaluate an activity-based program for parents and their children. The program is home-based and uses the mail for program delivery.
Read the detailed description
Youth whose parents smoke cigarettes are at high risk for early initiation of cigarette smoking, and youth who first smoke cigarettes during childhood are at high risk for subsequent addiction to tobacco. Parents influence their children's perceptions of the prevalence of smoking, the acceptability of smoking, the accessibility of cigarettes, and the personal and social consequences of smoking. All parents, including parents who smoke, can engage in anti-smoking socialization, which may lower children's risk of smoking.
Although there are some programs available that are directed at preventing initiation of smoking during childhood, none of these prevention programs engage parents who smoke in altering children's smoking-specific socialization. This study will evaluate a program to change smoking-specific socialization of children in households where parents smoke cigarettes.
Consenting volunteers will be randomly assigned to either treatment (anti-smoking socialization program) or control groups. Parents in the treatment group will participate in the "Smoke-free Kids" program and receive activity magazines, newsletters, and support calls. Parents in the control group will receive a fact sheet about youth smoking. Parents involved in the study will be assessed through a telephone interview 1 month after completion of the three-month anti-smoking program. Assenting children will complete surveys administered at school at 12, 24, and 36 months after completion of the anti-smoking program. Primary and secondary dependent variables include initiation of cigarette smoking and susceptibility to cigarette smoking by children. The child survey will also assess risk and protective factors.
- Conditions
- Smoking
- Being tested
- Anti-smoking Socialization Program
- Keywords
- Smoking, Primary Prevention, Health Education, Child, Parents, Parenting Education, Communication
- Medical subject headings
- Smoking, Health Education, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-smoking Socialization ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of cigarette smoking -- 3 years post treatment
Secondary outcomes (1)
Susceptibility for initiation of cigarette smoking -- 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2003 (estimated)
- Study startSep 1997
- Study completionAug 2002
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 SmokingStudies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,007 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Christine Jackson, Ph.D., Principal investigator, Pacific Institute for Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056927
- Sponsor's protocol ID
- 2R01HD36514-5
- Other IDs
- 2R01HD036514
- Status last verified
- Jul 2005
- First submitted
- 26 Mar 2003
- Last updated
- 2 Oct 2006
- Results posted
- No
Publications
Jackson C, Dickinson D. Can parents who smoke socialise their children against smoking? Results from the Smoke-free Kids intervention trial. Tob Control. 2003 Mar;12(1):52-9. doi: 10.1136/tc.12.1.52.
PubMed 12612363
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Initiation of Smoking by Children
- ClinicalTrials.gov ID
- NCT00056927
- Acronym / sponsor ID
- 2R01HD36514-5
- Conditions
- Smoking
- Keywords
- Smoking, Primary Prevention, Health Education, Child, Parents, Parenting Education, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,007 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 1997
- Study completion
- Aug 2002
- First posted
- 27 Mar 2003 (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 study is to determine whether an anti-smoking program for parents who smoke will lower the odds that their children will start smoking. The study will evaluate an activity-based program for parents and their children. The program is home-based and uses the mail for program delivery.
Detailed description
Youth whose parents smoke cigarettes are at high risk for early initiation of cigarette smoking, and youth who first smoke cigarettes during childhood are at high risk for subsequent addiction to tobacco. Parents influence their children's perceptions of the prevalence of smoking, the acceptability of smoking, the accessibility of cigarettes, and the personal and social consequences of smoking. All parents, including parents who smoke, can engage in anti-smoking socialization, which may lower children's risk of smoking.
Although there are some programs available that are directed at preventing initiation of smoking during childhood, none of these prevention programs engage parents who smoke in altering children's smoking-specific socialization. This study will evaluate a program to change smoking-specific socialization of children in households where parents smoke cigarettes.
Consenting volunteers will be randomly assigned to either treatment (anti-smoking socialization program) or control groups. Parents in the treatment group will participate in the "Smoke-free Kids" program and receive activity magazines, newsletters, and support calls. Parents in the control group will receive a fact sheet about youth smoking. Parents involved in the study will be assessed through a telephone interview 1 month after completion of the three-month anti-smoking program. Assenting children will complete surveys administered at school at 12, 24, and 36 months after completion of the anti-smoking program. Primary and secondary dependent variables include initiation of cigarette smoking and susceptibility to cigarette smoking by children. The child survey will also assess risk and protective factors.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents or guardians who smoke
- Have children in the 3rd grade
- Belong to participating school districts in North Carolina, South Carolina, or Colorado
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Anti-smoking Socialization Program | Behavioural | – |
Primary outcome
Initiation of cigarette smoking -- 3 years post treatment
1 secondary outcome
Susceptibility for initiation of cigarette smoking -- 1 year post treatment
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 Oct 2006.
- Background: PubMed 12612363Jackson C, Dickinson D. Can parents who smoke socialise their children against smoking? Results from the Smoke-free Kids intervention trial. Tob Control. 2003 Mar;12(1):52-9. doi: 10.1136/tc.12.1.52.
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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.
Christine Jackson, Ph.D. principal investigator
Pacific Institute for Research and Evaluation
Questions about this trial
What is this clinical trial studying?
A study testing Anti-smoking Socialization Program in people with Smoking, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 3 inclusion and 0 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 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Initiation of cigarette smoking -- 3 years post treatment. 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 NCT00056927, 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 Oct 2006.