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MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education) 4 Kids: Promoting Smoke-free Homes

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ClinicalTrials.gov Identifier: NCT01537874
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Tobacco Smoking Behavior Behavioral: Motivational Interview Behavioral: Usual best practices

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MassCONECT 4 Kids: Promoting Smoke-free Homes MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education)
Study Start Date : May 2010
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Motivational Interview Intervention
Motivational interviewing session (1 hour in home) plus 2 follow-up phone calls
Behavioral: Motivational Interview
30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques
Usual Best Practices
Standard care delivered using informational materials
Behavioral: Usual best practices
Standard care delivered using informational materials

Outcome Measures

Primary Outcome Measures :
  1. Voluntary adoption of a home smoking ban [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Self-reported smoking in the home [ Time Frame: 6 Months ]
  2. Household nicotine concentrations [ Time Frame: 6 Months ]
  3. Child salivary cotinine [ Time Frame: 6 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537874

United States, Massachusetts
Boston Alliance for Community Health
Boston, Massachusetts, United States
City of Lawrence Mayor's Health Task Force
Lawrence, Massachusetts, United States
Common Pathways
Worcester, Massachusetts, United States
Sponsors and Collaborators
Harvard School of Public Health
National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigator: Vaughan Rees, PhD Harvard School of Public Health
More Information

Responsible Party: Vaughan Rees, Lecturer, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01537874     History of Changes
Other Study ID Numbers: R24MD002772 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by Vaughan Rees, Harvard School of Public Health:
Secondhand smoke
Pediatric disease