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

Tobacco Smoking Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537874
• Other study ID #: R24MD002772
• Secondary ID: R24MD002772
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: May 19, 2014
• Start date: May 2010
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Smoking Behavior

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voluntary adoption of a home smoking ban		6 Months	No
Secondary	Self-reported smoking in the home		6 Months	No
Secondary	Household nicotine concentrations		6 Months	No
Secondary	Child salivary cotinine		6 Months	No