Clinical trial NCT01537874: MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education) 4 Kids: Promoting Smoke-free Homes
Official title: MassCONECT 4 Kids: Promoting Smoke-free Homes MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking Behavior
Keywords: Secondhand smoke
Pediatric disease
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2012-02-23
Enrollment: 138
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Voluntary adoption of a home smoking ban
timeFrame: 6 Months
Secondary outcomes:
measure: Self-reported smoking in the home
timeFrame: 6 Months
measure: Household nicotine concentrations
timeFrame: 6 Months
measure: Child salivary cotinine
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Alliance for Community Health
state: Massachusetts
city: Lawrence
country: United States
facility: City of Lawrence Mayor's Health Task Force
state: Massachusetts
city: Worcester
country: United States
facility: Common Pathways
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Vaughan Rees, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.