Tobacco Use CessationFRESHNCT02557919
Families Reduce Exposure to Smoke at Home
A study testing Motivational Interviewing Training and Usual Best Practice in people with Tobacco Use Cessation and Second Hand Tobacco Smoke, run by Harvard School of Public Health (HSPH).
Trial summary
This project proposes to evaluate the effectiveness of training Head Start staff to discuss tobacco use, shs reduction and cessation in their existing encounters with parents in reducing tobacco use and exposure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- What is being tested?
- Motivational Interviewing Training and Usual Best Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent Inclusion
- Parent of a child enrolled in an ABCD Early Head Start/Head Start Program
- Current smoker (1 or more cigarettes per day) and/or smoking is happening in or around (attached porches, patios, hallways) the family home by family members or regular visitors
- Able to complete a self-administered survey or request assistance from research staff
- Able to communicate in English or Spanish
- Staff Inclusion
- Staff member at one of the participating ABCD Head Start sites
- Willing to consent to complete the staff survey
Who cannot join
- Parent Exclusion
- Unable or unwilling to consent to participate in this research
- No smoking is happening in or around the home
- Staff Exclusion
- 1. Unwilling or unable to consent to complete the staff survey
About this study
Official title: Evaluation of the Smoking Cessation and Tobacco Use Exposure Patterns of Head Start Parents in Boston
This project proposes to evaluate the effectiveness of training Head Start staff to discuss tobacco use, shs reduction and cessation in their existing encounters with parents in reducing tobacco use and exposure. Understanding the facilitators and barriers to integrating the intervention into the Head Start system will support future efforts to address tobacco use and exposure in families with small children.
Read the detailed description
Parental smoking increases children's risk of asthma, infectious illness, sudden infant death syndrome (SIDS), and other conditions. Accumulating evidence regarding the adverse effects of total smoke exposure (TSE) led the US Surgeon General to conclude that there is no safe level of TSE. Parents who smoke endanger themselves, put their children and spouses at risk for adverse health outcomes, and increase the chance of their children becoming smokers. However, many parents who smoke are undertreated for their tobacco addiction. Many parents who smoke are of the age where they have few contacts with primary care physicians and are often unexposed to counseling and pharmacotherapy offered to older patients. Strategically identifying sites where trained para-professionals routinely interact with parents who smoke is vital to making inroads in this high-risk population.
Involuntary secondhand smoke exposure (SHSe) in domestic environments is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Research has indicated that interventions to reduce SHSe for children delivered through child care settings have been effective. In addition, client-centered approaches, such as motivational interviewing, have been effective in helping parents to reduce levels of SHS in the home environment. Following guidelines from established agencies and organizations, we will also evaluate changes in smoking cessation rates among parents and staff comparing use prior to and after the training programs and subsequent family service worker to parent encounters.
Aim 1: Building on Action for Boston Community Development's (ABCD) current system efforts, support the development and implementation of system changes to accurately and efficiently document parental smoking and household tobacco use and exposure, using: i) intake form, ii) Individual Family Plan, and iii) electronic data system.
Aim 2: Collaborate with Legacy and University of Massachusetts (UMass) to train Head Start staff in skills for encouraging smoking cessation and on a smoke-free home intervention, to increase staff knowledge of second-hand smoke (SHS) effects and provide skills in Motivational Interviewing. This will enhance staff confidence in engaging with parents to assist in efforts to make a sustained quit attempt, reduce children's SHS exposure, and will provide structure to help staff determine how best to support families on issues of tobacco use, including referral to cessation services.
Aim 3: Evaluate the effectiveness of sites receiving the a) Motivational Interviewing intervention for family service workers, b) supervisor education, and c) boosters in decreasing parent smoking, reducing household tobacco use and children's SHS exposure, compared with sites receiving only basic tobacco information.
Aim 4: Evaluate the effectiveness of the smoking cessation intervention on the staff most intimately involved in parent counseling-namely, the family service workers who will attend the training program (s). We will evaluate their knowledge, attitudes, beliefs, and smoking practices as well as their confidence and skills in tobacco-related counseling.
- Conditions
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- Being tested
- Motivational Interviewing Training, Usual Best Practice
- 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.
Motivational Interviewing TrainingOther
1.5 day training on Motivational Interviewing (MI) techniques plus 2 booster sessions to address real experiences using MI with families.
Usual Best PracticeOther
.5 day training on tobacco control and emerging products.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Training | Experimental | Staff at the intervention sites were trained in basic tobacco control and motivational interviewing. Two booster trainings were held over 6 months. Receives: Other: Motivational Interviewing Training |
| Usual Best Practice | Other | Staff at the usual best practice sites received basic tobacco control training. Receives: Other: Usual Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco quit attempts in the past 6 months (staff and parents)
Parents and staff will be surveyed to determine the number of quit attempts in the past 6 months.
Measured: Past 6 months
Secondary outcomes (1)
Home smoking ban implemented in the past 6 months
Parents will be surveyed to determine the number of home smoking bans implemented in the past 6 months.
Measured: Past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Truth Initiative
- Responsible party
- Principal investigator, Alan Geller, Harvard School of Public Health (HSPH)
- Investigators
- Alan C Geller, RN, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557919
- Sponsor's protocol ID
- 13-0683
- Acronym
- FRESH
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Smoking Cessation and Tobacco Use Exposure Patterns of Head Start Parents in Boston
- ClinicalTrials.gov ID
- NCT02557919
- Acronym / sponsor ID
- FRESH / 13-0683
- Conditions
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Truth Initiative
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Sep 2015 (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.
This project proposes to evaluate the effectiveness of training Head Start staff to discuss tobacco use, shs reduction and cessation in their existing encounters with parents in reducing tobacco use and exposure. Understanding the facilitators and barriers to integrating the intervention into the Head Start system will support future efforts to address tobacco use and exposure in families with small children.
Detailed description
Parental smoking increases children's risk of asthma, infectious illness, sudden infant death syndrome (SIDS), and other conditions. Accumulating evidence regarding the adverse effects of total smoke exposure (TSE) led the US Surgeon General to conclude that there is no safe level of TSE. Parents who smoke endanger themselves, put their children and spouses at risk for adverse health outcomes, and increase the chance of their children becoming smokers. However, many parents who smoke are undertreated for their tobacco addiction. Many parents who smoke are of the age where they have few contacts with primary care physicians and are often unexposed to counseling and pharmacotherapy offered to older patients. Strategically identifying sites where trained para-professionals routinely interact with parents who smoke is vital to making inroads in this high-risk population.
Involuntary secondhand smoke exposure (SHSe) in domestic environments is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Research has indicated that interventions to reduce SHSe for children delivered through child care settings have been effective. In addition, client-centered approaches, such as motivational interviewing, have been effective in helping parents to reduce levels of SHS in the home environment. Following guidelines from established agencies and organizations, we will also evaluate changes in smoking cessation rates among parents and staff comparing use prior to and after the training programs and subsequent family service worker to parent encounters.
Aim 1: Building on Action for Boston Community Development's (ABCD) current system efforts, support the development and implementation of system changes to accurately and efficiently document parental smoking and household tobacco use and exposure, using: i) intake form, ii) Individual Family Plan, and iii) electronic data system.
Aim 2: Collaborate with Legacy and University of Massachusetts (UMass) to train Head Start staff in skills for encouraging smoking cessation and on a smoke-free home intervention, to increase staff knowledge of second-hand smoke (SHS) effects and provide skills in Motivational Interviewing. This will enhance staff confidence in engaging with parents to assist in efforts to make a sustained quit attempt, reduce children's SHS exposure, and will provide structure to help staff determine how best to support families on issues of tobacco use, including referral to cessation services.
Aim 3: Evaluate the effectiveness of sites receiving the a) Motivational Interviewing intervention for family service workers, b) supervisor education, and c) boosters in decreasing parent smoking, reducing household tobacco use and children's SHS exposure, compared with sites receiving only basic tobacco information.
Aim 4: Evaluate the effectiveness of the smoking cessation intervention on the staff most intimately involved in parent counseling-namely, the family service workers who will attend the training program (s). We will evaluate their knowledge, attitudes, beliefs, and smoking practices as well as their confidence and skills in tobacco-related counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Training | Experimental | Other: Motivational Interviewing TrainingStaff at the intervention sites were trained in basic tobacco control and motivational interviewing. Two booster trainings were held over 6 months. |
| Usual Best Practice | Other | Other: Usual Best PracticeStaff at the usual best practice sites received basic tobacco control training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Parent Inclusion
- Staff Inclusion
- Staff member at one of the participating ABCD Head Start sites
- Willing to consent to complete the staff survey
Key exclusion criteria (5 listed)
- Parent Exclusion
- Staff Exclusion
- 1. Unwilling or unable to consent to complete the staff survey
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 |
|---|---|---|
| Motivational Interviewing Training1.5 day training on Motivational Interviewing (MI) techniques plus 2 booster sessions to address real experiences using MI with families. | Other | Motivational Interviewing Training |
| Usual Best Practice.5 day training on tobacco control and emerging products. | Other | Usual Best Practice |
Primary outcome
Tobacco quit attempts in the past 6 months (staff and parents)
Time frame: Past 6 months
Parents and staff will be surveyed to determine the number of quit attempts in the past 6 months.
1 secondary outcome
Home smoking ban implemented in the past 6 months
Time frame: Past 6 months
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 23 Sep 2015.
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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.
Alan C Geller, RN, MPH principal investigator
Harvard School of Public Health (HSPH)
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Training and Usual Best Practice in people with Tobacco Use Cessation and Second Hand Tobacco Smoke, run by Harvard School of Public Health (HSPH).
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 8 inclusion and 5 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 23 Sep 2015. 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?
Tobacco quit attempts in the past 6 months (staff and parents) (time frame: Past 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2015.