NCT00664261

Brief Summary

RATIONALE: The Clinical Effort Against Secondhand Smoke (CEASE) program may be more effective than standard care in increasing the number of parents who stop smoking. PURPOSE: This randomized clinical trial is studying how well the CEASE program works compared with standard care in helping parents stop smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 18, 2013

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

April 19, 2008

Last Update Submit

December 17, 2013

Conditions

Keywords

tobacco use disorder

Outcome Measures

Primary Outcomes (2)

  • Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit

  • Rates of 7-day abstinence as confirmed biochemically at 12 months after clinic visit

Secondary Outcomes (10)

  • Rates of clinician asking about parental smoking as assessed by parent surveys at baseline and 12 months after clinic visit

  • Rates of clinician advising parents to quit as assessed by parent surveys at baseline and 12 months after clinic visit

  • Rates of clinician counseling parents about institution of rules prohibiting smoking in the home and car as assessed by parent surveys at baseline and 12 months after clinic visit

  • Percentage of parental smokers who have 7-day abstinence at both 3 and 12 months after clinic visit

  • Percentage of parental smokers reported quit attempts lasting at least 24 hours as assessed by parent surveys at baseline, 3 months, and 12 months after clinic visit

  • +5 more secondary outcomes

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Parents or guardians meeting the following criteria: * Self-identified as smokers on the baseline survey * Must have a child who is seen by a pediatrician in a participating practice * Child must not have a medically emergent condition that requires transfer outside the practice for immediate medical intervention * Must be present at the child's healthcare visit * Pediatric practice meeting the following criteria: * Participates in the Pediatric Research in Office Settings (PROS) network * Practice manager and a majority of pediatricians are willing to implement a tobacco control strategy for parental smokers * Cares for at least 2,000 families * Located in a geographically distinct location to minimize contamination effects of the intervention * No practices at the same geographic location PATIENT CHARACTERISTICS: * Have a telephone at home (parent or guardian) * Able to speak English (parent or guardian) * Have a working fax machine (practice) PRIOR CONCURRENT THERAPY: * No prior enrollment in this study during a previous visit to the pediatric healthcare clinician (parent or guardian) * No prior participation in phase II focus groups or other pilot tobacco control studies (practice) * No active enrollment of patients onto other PROS trials (practice)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (8)

  • Drehmer JE, Hipple B, Ossip DJ, Nabi-Burza E, Winickoff JP. A Cross-Sectional Study of Happiness and Smoking Cessation among Parents. J Smok Cessat. 2017 Mar;12(1):6-14. doi: 10.1017/jsc.2015.6. Epub 2015 Mar 24.

  • Drehmer JE, Hipple B, Nabi-Burza E, Ossip DJ, Chang Y, Rigotti NA, Winickoff JP. Proactive enrollment of parents to tobacco quitlines in pediatric practices is associated with greater quitline use: a cross-sectional study. BMC Public Health. 2016 Jun 24;16:520. doi: 10.1186/s12889-016-3147-1.

  • Winickoff JP, Nabi-Burza E, Chang Y, Regan S, Drehmer J, Finch S, Wasserman R, Ossip D, Hipple B, Woo H, Klein J, Rigotti NA. Sustainability of a parental tobacco control intervention in pediatric practice. Pediatrics. 2014 Nov;134(5):933-41. doi: 10.1542/peds.2014-0639. Epub 2014 Oct 20.

  • Mahabee-Gittens EM, Collins BN, Murphy S, Woo H, Chang Y, Dempsey J, Weiley V, Winickoff JP. The parent-child dyad and risk perceptions among parents who quit smoking. Am J Prev Med. 2014 Nov;47(5):596-603. doi: 10.1016/j.amepre.2014.07.010. Epub 2014 Sep 4.

  • Drehmer JE, Ossip DJ, Nabi-Burza E, Rigotti NA, Hipple B, Woo H, Chang Y, Winickoff JP. Thirdhand smoke beliefs of parents. Pediatrics. 2014 Apr;133(4):e850-6. doi: 10.1542/peds.2013-3392. Epub 2014 Mar 3.

  • Winickoff JP, Nabi-Burza E, Chang Y, Finch S, Regan S, Wasserman R, Ossip D, Woo H, Klein J, Dempsey J, Drehmer J, Hipple B, Weiley V, Murphy S, Rigotti NA. Implementation of a parental tobacco control intervention in pediatric practice. Pediatrics. 2013 Jul;132(1):109-17. doi: 10.1542/peds.2012-3901.

  • Friebely J, Rigotti NA, Chang Y, Hall N, Weiley V, Dempsey J, Hipple B, Nabi-Burza E, Murphy S, Woo H, Winickoff JP. Parent smoker role conflict and planning to quit smoking: a cross-sectional study. BMC Public Health. 2013 Feb 22;13:164. doi: 10.1186/1471-2458-13-164.

  • Drehmer JE, Ossip DJ, Rigotti NA, Nabi-Burza E, Woo H, Wasserman RC, Chang Y, Winickoff JP. Pediatrician interventions and thirdhand smoke beliefs of parents. Am J Prev Med. 2012 Nov;43(5):533-6. doi: 10.1016/j.amepre.2012.07.020.

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

CounselingEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Jonathan Winickoff, MD, MPH

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2008

First Posted

April 22, 2008

Study Start

September 1, 2007

Primary Completion

September 1, 2011

Study Completion

July 1, 2013

Last Updated

December 18, 2013

Record last verified: 2011-06

Locations