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Tobacco Use DisorderPhase 2NCT00098215

Pediatric Residency Training On Tobacco

A Phase 2 study testing Pediatric residency training on tobacco in people with Tobacco Use Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 14 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether a specialized, technology-based training program in tobacco prevention is more effective than standard training for pediatric residents who counsel youth and their parents. Read more about this study

Who is it for?
Ages 0 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use Disorder
What is being tested?
Pediatric residency training on tobacco
How many people
4,000 participants
Where
14 sitesUnited States
Study dates
Mar 2001to Feb 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

The training program will include all residents enrolled in the 14 participating residency training programs.

The Baseline and Follow-up Resident Tobacco Surveys and OSCEs will include all second and third year residents enrolled in the residency training programs at baseline and years 1, 2, and 3 of follow-up.

The Baseline and Follow-up Patient Tobacco Survey will include 30 patients, ages 12-21, who were present in the waiting areas of the Continuity Clinic when the surveys were administered. All patients present in the clinic will be approached and invited to participate. Partcipants must be able to read English or Spanish, and patients who are attending the clinic for the very first time will not be eligible to participate in the survey.

The Baseline and Follow-up Parent Tobacco Surveys will be administered to 100 parents (one per family) who are present in the clinic when the surveys are administered. Parents who cannot read English or Spanish and who are bringing their child to the clinic for the very first time will not be able to participate.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites, 14 recruiting
  • Long Island College Hospital

    Brooklyn, New York, 11201

    Umit Emre, MD, 718-780-1025

    Recruiting
  • Woodhull Medical and Mental Health Center

    Brooklyn, New York, 11206-5317

    John Moohr, MD, 718-963-8778

    Recruiting
  • Brooklyn Hospital Center Program

    Brooklyn, New York, 11212

    Theodoros Raptis, MD, 718-250-6209, mjs9005@nyp.org

    Recruiting
  • UMDNJ-Robert Wood Johnson Medical School

    Camden, New Jersey, 08103-1489

    William Graessle, MD, 856-342-2472, Graessle-Bill@cooperhealth.edu

    Recruiting
  • Nassau County Medical Center

    East Meadow, New York, 11554

    Stephen P Katz, MD, 516-572-6177

    Recruiting
  • New York Flushing Hospital Medical Center

    Flushing, New York, 11355

    Fatema Meah, MD, 718-670-3145

    Recruiting
  • Mount Sinai School of Medicine (Jersey City Program)

    Jersey City, New Jersey, 07304

    Richard Bonforte, MD, 201-915-2455, rbonforte@libertyhcs.org

    Recruiting
  • Winthrop-University Hospital Program

    Mineola, New York, 516-663-2288

    Stephen Marino, DO, 516-663-4423

    Recruiting
  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07754

    Alan Cabasso, MD, 732-776-4269, jsmcped@aol.com

    Recruiting
  • New York and Presbyterian Hospital (Cornell Campus) Program

    New York, New York, 10021

    Susan Bostwick, MD, 212-746-3522

    Recruiting
  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Joshua S Rosenblatt, MD, 973-926-7040, josh@bethi.com

    Recruiting
  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

    Thomas Daley, MD, 973-754-2619, daleyt@sjhmc.org

    Recruiting
  • Lincoln Medical Center

    The Bronx, New York, 10451

    Hermann Mendez, MD, 718-780-1025

    Recruiting
  • Bronx/Lebanon Hospital

    The Bronx, New York, 10457

    Ronald Bainbridge, MD, 718-518-5760

    Recruiting

Other trials in United States

About this study

Official title: Pediatric Residency Training on Tobacco

The purpose of this study is to determine whether a specialized, technology-based training program in tobacco prevention is more effective than standard training for pediatric residents who counsel youth and their parents.

Read the detailed description

The American Academy of Pediatrics and other leading health agencies call upon pediatricians to address environmental tobacco smoke (ETS), prevent smoking onset in youths, and encourage cessation of tobacco use by adolescents and their parents. Systematic intervention on tobacco by pediatricians would protect infants and young children from the harmful effects of ETS and save adolescents from a lifetime of addiction and tobacco-related disease. Despite this, few pediatricians address tobacco use, and pediatric residency training programs are not preparing residents to play a leadership role in the anti-tobacco arena.

The Pediatric Residency Training on Tobacco project is a four-year randomized controlled study of the efficacy of a specialized tobacco intervention program for pediatric residents. Eight participating pediatric training sites were randomly assigned to a Special Training condition featuring "Solutions for Smoking", a hybrid CD-ROM/Website training program. Six sites were randomly assigned to a control condition that provided standard print literature. Key features of "Solutions for Smoking" include a website containing background material on tobacco, interviewing, behavioral and pharmacological aspects of intervention, and a series of CD-ROMs containing audio-visual vignettes that model state-of-the-art interviewing and tobacco intervention skills. Residents are expected to practice the interventions with patients in their Continuity Clinics, and all sites are provided with brochures and other intervention materials for this purpose. Study investigators meet with residents at all sites three times per year to discuss the program and the residents' efforts to intervene on tobacco with their patients. Annually, second and third-year residents participate in Objective Structured Clinical Examinations (OSCEs) and a Resident Tobacco Survey. Patients and parents attending each of the Continuity Clinics complete Patient and Parent Tobacco Surveys at baseline and end of study.

Primary endpoints include changes over time in pediatric residents' tobacco intervention knowledge, skills, and activities as reported on the Tobacco Surveys and measured by performance on the OSCEs at baseline and follow-up. Secondary endpoints include changes in smoking, other tobacco use, and control of ETS by patients and parents. The study hypothesizes that pediatric residents in both arms of the study will be similar in knowledge and skills at baseline; that residents in the specialized training program will acquire more knowledge and greater skills for tobacco intervention during the course of the study compared to residents in the control condition; and residents in each condition will increase the frequency in which they address tobacco in patients and parents.

Being tested
Pediatric residency training on tobacco
Keywords
Residency training
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pediatric residency training on tobaccoBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2004 (estimated)
  2. Study startMar 2001
  3. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098215
Sponsor's protocol ID
1R01HD40683-1
Other IDs
1R01HD040683
Status last verified
Dec 2004
First submitted
3 Dec 2004
Last updated
10 Nov 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pediatric residency training on tobacco in people with Tobacco Use Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2005.

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