- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537874
MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education) 4 Kids: Promoting Smoke-free Homes
May 19, 2014 updated by: Vaughan Rees, Harvard School of Public Health (HSPH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Boston Alliance for Community Health
-
Lawrence, Massachusetts, United States
- City of Lawrence Mayor's Health Task Force
-
Worcester, Massachusetts, United States
- Common Pathways
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interview Intervention
Motivational interviewing session (1 hour in home) plus 2 follow-up phone calls
|
30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques
|
|
Other: Usual Best Practices
Standard care delivered using informational materials
|
Standard care delivered using informational materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Voluntary adoption of a home smoking ban
Time Frame: 6 Months
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-reported smoking in the home
Time Frame: 6 Months
|
6 Months
|
|
Household nicotine concentrations
Time Frame: 6 Months
|
6 Months
|
|
Child salivary cotinine
Time Frame: 6 Months
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vaughan Rees, PhD, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
February 17, 2012
First Submitted That Met QC Criteria
February 22, 2012
First Posted (Estimate)
February 23, 2012
Study Record Updates
Last Update Posted (Estimate)
May 20, 2014
Last Update Submitted That Met QC Criteria
May 19, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R24MD002772 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Smoking Behavior
-
University of Colorado, DenverUniversity of OklahomaRecruitingSmoking Cessation | Tobacco | Quitting Smoking | Tobacco Abstinence | Smoking (Tobacco) Addiction | Smoking ( Cigarette)United States
-
Johns Hopkins UniversityNational Center for Advancing Translational Sciences (NCATS); Community Partnership...CompletedSmoking Cessation | Smoking Reduction | Smoking, TobaccoUnited States
-
University of MinnesotaNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruiting
-
Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Memorial Sloan Kettering Cancer CenterRecruitingSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Smoking Behaviors | Smoking Habit | Smoking (Tobacco) AddictionUnited States
-
Michigan State UniversityUniversity of Michigan; Wake Forest University Health Sciences; Babes-Bolyai...RecruitingSmoking Cessation | Tobacco SmokingRomania
-
Virginia Polytechnic Institute and State UniversityMedical University of South Carolina; National Cancer Institute (NCI)CompletedCigarette Smoking BehaviorUnited States
-
Virginia Polytechnic Institute and State UniversityNational Cancer Institute (NCI); Roswell Park Comprehensive Cancer CenterNot yet recruitingCigarette Smoking BehaviorUnited States
-
RAI Services CompanyNot yet recruitingSmoking | TobaccoUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)Completed
Clinical Trials on Motivational Interview
-
Ohio UniversityNew York Blood CenterCompleted
-
Centro Hospitalar Lisboa NorteUniversity of Lisbon; Faculdade de Psicologia e de Ciências de Educação da...Unknown
-
Kahramanmaras Sutcu Imam UniversityEnrolling by invitation
-
T.C. ORDU ÜNİVERSİTESİCompleted
-
Abdullah GerçekCompletedHemodialysis Complication | Motivation | Patient ComplianceTurkey
-
Istanbul University-CerrahpasaCompleted
-
Odense University HospitalCompletedPolycystic Ovary Syndrome | Overweight and Obesity | Motivation
-
Afyonkarahisar Health Sciences UniversityNot yet recruiting
-
Sultan Ayaz AlkayaCompleted