Tobacco Smoking BehaviorNCT01537874
MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education) 4 Kids: Promoting Smoke-free Homes
A study testing Motivational Interview and Usual best practices in people with Tobacco Smoking Behavior, run by Harvard School of Public Health (HSPH) at 3 sites in United States.
Trial summary
This study evaluates the effectiveness of a motivational interviewing intervention with families with young children ages 0-5 where smoking is happening in the home to adopt a smoke-free home plan and reduce child's second-hand smoke exposure. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking Behavior
- What is being tested?
- Motivational Interview and Usual best practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Apr 2013
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Tobacco smoking occurs regularly (smoke a minimum of one cigarette/cigar per day or five cigarettes/cigars per week) inside the home or in an attached patio/porch, hallway or stairwell
- Primary caregiver of child aged birth to 5 years old (inclusive) enrolled in Massachusetts Early Intervention program, Healthy Families program or the general population in Boston, Lawrence and Worcester areas.
- Ability of a custodial parent aged 17 or older/legally authorized representative or primary caregiver of child enrolled in participating programs to give permission for the index child to provide saliva sample.
- Participant has access to a telephone to schedule study contacts and participate in follow-up calls
Who cannot join
- Not able to understand English or Spanish at a 8th grade level or above
- In poor physical or psychological health (self-reported and observed by Community Health Worker), for whom participating in this intervention study might compromise the child's or participant's welfare, or be impracticable
- Index child is a ward of the state
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Alliance for Community Health
Boston, Massachusetts
City of Lawrence Mayor's Health Task Force
Lawrence, Massachusetts
Common Pathways
Worcester, Massachusetts
About this study
Official title: MassCONECT 4 Kids: Promoting Smoke-free Homes MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education)
This study evaluates the effectiveness of a motivational interviewing intervention with families with young children ages 0-5 where smoking is happening in the home to adopt a smoke-free home plan and reduce child's second-hand smoke exposure.
Read the detailed description
Involuntary secondhand smoke (SHS) exposure in homes is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Breathe Free For Kids is a community-based participatory research (CBPR) initiative to evaluate the effectiveness of Ml compared with usual best practices (UBP) by having parents voluntarily adopt smoke-free home policies to protect children from SHS. The Motivational Interviewing intervention protocol was developed in conjunction with community partners, integrated into a health department-sponsored home visiting program for high-risk children and other community-based agencies serving children, and delivered by trained community health workers.
- Conditions
- Tobacco Smoking Behavior
- Being tested
- Motivational Interview, Usual best practices
- Keywords
- Secondhand smoke, Pediatric disease
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques
Usual best practicesBehavioural
Standard care delivered using informational materials
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview Intervention | Experimental | Motivational interviewing session (1 hour in home) plus 2 follow-up phone calls Receives: Behavioral: Motivational Interview |
| Usual Best Practices | Other | Standard care delivered using informational materials Receives: Behavioral: Usual best practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary adoption of a home smoking ban
Measured: 6 Months
Secondary outcomes (3)
Self-reported smoking in the home
Measured: 6 Months
Household nicotine concentrations
Measured: 6 Months
Child salivary cotinine
Measured: 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 Feb 2012 (estimated)
- Study startMay 2010
- Primary completionApr 2013
- Study completionApr 2013
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 Smoking BehaviorStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Vaughan Rees, Harvard School of Public Health (HSPH)
- Investigators
- Vaughan Rees, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537874
- Sponsor's protocol ID
- R24MD002772
- Other IDs
- R24MD002772
- Status last verified
- May 2014
- First submitted
- 17 Feb 2012
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Keske RR, Rees VW, Behm I, Wadler BM, Geller AC. Second-hand smoke exposure and mitigation strategies among home visitation workers. Tob Control. 2013 Jul;22(4):250-4. doi: 10.1136/tobaccocontrol-2011-050133. Epub 2011 Dec 18.
PubMed 22184207
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MassCONECT 4 Kids: Promoting Smoke-free Homes MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education)
- ClinicalTrials.gov ID
- NCT01537874
- Acronym / sponsor ID
- R24MD002772
- Conditions
- Tobacco Smoking Behavior
- Keywords
- Secondhand smoke, Pediatric disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- May 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Feb 2012 (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 study evaluates the effectiveness of a motivational interviewing intervention with families with young children ages 0-5 where smoking is happening in the home to adopt a smoke-free home plan and reduce child's second-hand smoke exposure.
Detailed description
Involuntary secondhand smoke (SHS) exposure in homes is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Breathe Free For Kids is a community-based participatory research (CBPR) initiative to evaluate the effectiveness of Ml compared with usual best practices (UBP) by having parents voluntarily adopt smoke-free home policies to protect children from SHS. The Motivational Interviewing intervention protocol was developed in conjunction with community partners, integrated into a health department-sponsored home visiting program for high-risk children and other community-based agencies serving children, and delivered by trained community health workers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview Intervention | Experimental | Behavioral: Motivational InterviewMotivational interviewing session (1 hour in home) plus 2 follow-up phone calls |
| Usual Best Practices | Other | Behavioral: Usual best practicesStandard care delivered using informational materials |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Tobacco smoking occurs regularly (smoke a minimum of one cigarette/cigar per day or five cigarettes/cigars per week) inside the home or in an attached patio/porch, hallway or stairwell
- Primary caregiver of child aged birth to 5 years old (inclusive) enrolled in Massachusetts Early Intervention program, Healthy Families program or the general population in Boston, Lawrence and Worcester areas.
- Ability of a custodial parent aged 17 or older/legally authorized representative or primary caregiver of child enrolled in participating programs to give permission for the index child to provide saliva sample.
- Participant has access to a telephone to schedule study contacts and participate in follow-up calls
Key exclusion criteria (3 listed)
- Not able to understand English or Spanish at a 8th grade level or above
- In poor physical or psychological health (self-reported and observed by Community Health Worker), for whom participating in this intervention study might compromise the child's or participant's welfare, or be impracticable
- Index child is a ward of the state
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 Interview30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques | Behavioural | Motivational Interview Intervention |
| Usual best practicesStandard care delivered using informational materials | Behavioural | Usual Best Practices |
Primary outcome
Voluntary adoption of a home smoking ban
Time frame: 6 Months
3 secondary outcomes
Self-reported smoking in the home
Time frame: 6 Months
Household nicotine concentrations
Time frame: 6 Months
Child salivary cotinine
Time frame: 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 20 May 2014.
- Background: PubMed 22184207Keske RR, Rees VW, Behm I, Wadler BM, Geller AC. Second-hand smoke exposure and mitigation strategies among home visitation workers. Tob Control. 2013 Jul;22(4):250-4. doi: 10.1136/tobaccocontrol-2011-050133. Epub 2011 Dec 18.
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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.
Vaughan Rees, PhD principal investigator
Harvard School of Public Health (HSPH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview and Usual best practices in people with Tobacco Smoking Behavior, run by Harvard School of Public Health (HSPH) at 3 sites 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Voluntary adoption of a home smoking ban (time frame: 6 Months). 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 NCT01537874, 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 20 May 2014.