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MassCONECT 4 Kids: Promoting Smoke-free Homes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Center on Minority Health and Health Disparities (NCMHD)
Information provided by (Responsible Party):
Vaughan Rees, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01537874
First received: February 17, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Tobacco Smoking Behavior
 Behavioral: Motivational Interview
Behavioral: Usual best practices

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MassCONECT 4 Kids: Promoting Smoke-free Homes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Voluntary adoption of a home smoking ban [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported smoking in the home [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Household nicotine concentrations [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Child salivary cotinine [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: May 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537874

Locations
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 Center on Minority Health and Health Disparities (NCMHD)
Investigators
Principal Investigator: Vaughan Rees, PhD Harvard School of Public Health
  More Information

Publications:

Responsible Party: Vaughan Rees, Lecturer, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01537874     History of Changes
Other Study ID Numbers: R24MD002772, R24MD002772
Study First Received: February 17, 2012
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 19, 2013