NCT01745393

Brief Summary

The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 8, 2018

Completed
Last Updated

August 8, 2018

Status Verified

July 1, 2018

Enrollment Period

4.3 years

First QC Date

November 12, 2012

Results QC Date

May 29, 2018

Last Update Submit

July 10, 2018

Conditions

Second Hand Tobacco SmokeNicotine Dependence

Keywords

Smoking CessationSecondhand SmokePassive SmokingCotinineNicotine Replacement Products

Outcome Measures

Primary Outcomes (2)

  • Child Urine Cotinine

    Child urine cotinine is a biomarker for assessing second-hand smoke exposure. We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.

    up to 12 months

  • Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources

    Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment. We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.

    up to 12 months

Secondary Outcomes (1)

  • Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence

    up to 12 months

Study Arms (2)

Clinic Quality Improvement + Behavioral Counseling

EXPERIMENTAL

This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.

Behavioral: Clinic Quality Improvement + Behavioral Counseling

Clinic Quality Improvement + Attention Control

ACTIVE COMPARATOR

The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.

Behavioral: Clinic Quality Improvement + Attention Control

Interventions

Clinic Quality Improvement + Behavioral CounselingBEHAVIORAL
Clinic Quality Improvement + Behavioral Counseling
Clinic Quality Improvement + Attention ControlBEHAVIORAL
Clinic Quality Improvement + Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • English-speaking
  • parent or legal guardian of child under 11 years old who lives with him/her
  • daily smoker

You may not qualify if:

  • non-nicotine drug dependence
  • psychiatric disturbance (bipolar, schizophrenia, psychosis)
  • pregnant
  • inadequate health literacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Children's Hospital of Philadephia

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Temple University Hospital System

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (5)

  • Lepore SJ, Winickoff JP, Moughan B, Bryant-Stephens TC, Taylor DR, Fleece D, Davey A, Nair US, Godfrey M, Collins BN. Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children. BMC Public Health. 2013 Aug 30;13:792. doi: 10.1186/1471-2458-13-792.

    PMID: 23987302RESULT

  • Collins BN, Lepore SJ, Winickoff JP, Nair US, Moughan B, Bryant-Stephens T, Davey A, Taylor D, Fleece D, Godfrey M. An Office-Initiated Multilevel Intervention for Tobacco Smoke Exposure: A Randomized Trial. Pediatrics. 2018 Jan;141(Suppl 1):S75-S86. doi: 10.1542/peds.2017-1026K.

    PMID: 29292308RESULT

  • Chin SM, Lepore SJ, Collins BN, Dumenci L, Rincon MA. Validation and Psychometric Properties of the Tobacco Urge Management Scale (TUMS). Int J Environ Res Public Health. 2023 Apr 10;20(8):5453. doi: 10.3390/ijerph20085453.

    PMID: 37107735DERIVED

  • Collins BN, Lepore SJ, Winickoff JP, Sosnowski DW. Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial. Nicotine Tob Res. 2020 Oct 29;22(11):1981-1988. doi: 10.1093/ntr/ntz175.

    PMID: 31536116DERIVED

  • Lepore SJ, Collins BN, Sosnowski DW. Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention. Drug Alcohol Depend. 2019 Nov 1;204:107496. doi: 10.1016/j.drugalcdep.2019.05.027. Epub 2019 Aug 24.

    PMID: 31499240DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Bradley Collins
Organization
Temple University
collinsb@temple.edu
215-204-2849

Study Officials

  • Brad Collins, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

  • Stephen Lepore, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 12, 2012

First Posted

December 10, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 8, 2018

Results First Posted

August 8, 2018

Record last verified: 2018-07

Locations

US(4)