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NCT02117947 · ClinicalTrials.gov registry record · NA

Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers

A NA study, sponsored by Temple University.

Completed
Registry status
NA
Development phase
300
Enrollment target

NCT02117947 is a NA study that has completed, run by Temple University. The registered enrollment target is 300 participants.

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The verdict

NCT02117947, a NA study, has completed, sponsored by Temple University.

COMPLETED
Registry status
NA
Development phase
300 participants
Enrollment target

Study Summary

The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved population of maternal smokers. The program is called "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After determining study eligibility via telephone screen, all participants complete an in-home pre-intervention interview that includes self-reported smoking history, current smoking and exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms, weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a biomarker used to detect SHSe). Participants are randomized after baseline to receive either (a) a moderately intensive (up to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered over a 16-week period by counselors trained and supervised by investigators, or (b) an enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of intervention process, factors associated with intervention effects, and intervention outcomes that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine (to verify self-reported smoking quit status). Interviewers and data management staff remain blind to the treatment assignment. All procedures are implemented after signed informed consent and were approved by Temple University's Institutional Review Board.

Interventions

  • BEHAVIORAL Behavioral Counseling
  • BEHAVIORAL Self-help control

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2004-07
Est. Completion 2011-06
Phase NA

Sponsor

Temple University

163 total trials

What the Registry Record Tells You About NCT02117947

The ClinicalTrials.gov registry entry for NCT02117947 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Behavioral Counseling is the first listed.

NCT02117947 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02117947 about?

NCT02117947 is a clinical study titled "Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers". The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved population of maternal smokers. The program is called "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income urban...

What is the current status of trial NCT02117947?

This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2004-07. Estimated completion is 2011-06.

What interventions are being tested in trial NCT02117947?

The interventions under investigation include: Behavioral Counseling (BEHAVIORAL), Self-help control (BEHAVIORAL).

Who is sponsoring clinical trial NCT02117947?

This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.