NCT01537874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

February 17, 2012

Last Update Submit

May 19, 2014

Conditions

Tobacco Smoking Behavior

Keywords

Secondhand smokePediatric disease

Outcome Measures

Primary Outcomes (1)

  • Voluntary adoption of a home smoking ban

    6 Months

Secondary Outcomes (3)

  • Self-reported smoking in the home

    6 Months

  • Household nicotine concentrations

    6 Months

  • Child salivary cotinine

    6 Months

Study Arms (2)

Motivational Interview Intervention

EXPERIMENTAL

Motivational interviewing session (1 hour in home) plus 2 follow-up phone calls

Behavioral: Motivational Interview

Usual Best Practices

OTHER

Standard care delivered using informational materials

Behavioral: Usual best practices

Interventions

Motivational InterviewBEHAVIORAL

30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques

Motivational Interview Intervention
Usual best practicesBEHAVIORAL

Standard care delivered using informational materials

Usual Best Practices

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston Alliance for Community Health

Boston, Massachusetts, United States

Location

City of Lawrence Mayor's Health Task Force

Lawrence, Massachusetts, United States

Location

Common Pathways

Worcester, Massachusetts, United States

Location

Related 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.

    PMID: 22184207BACKGROUND

MeSH Terms

Conditions

Smoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vaughan Rees, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

May 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

US(3)