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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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 groups in NCT02557919
Study groupRoleWhat they receive
Motivational Interviewing TrainingExperimentalStaff 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 PracticeOtherStaff 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.

  1. 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)
  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.

  1. First posted23 Sep 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2014
  4. Study completionDec 2014

Resources

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)
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

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.

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