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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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.
- Conditions
- Tobacco Use Disorder
- 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.
- First posted6 Dec 2004 (estimated)
- Study startMar 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Joseph Schwab, M.D., Principal investigator, New Jersey Medical School
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Residency Training on Tobacco
- ClinicalTrials.gov ID
- NCT00098215
- Acronym / sponsor ID
- 1R01HD40683-1
- Conditions
- Tobacco Use Disorder
- Keywords
- Residency training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Feb 2006
- First posted
- 6 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric residency training on tobacco | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UMDNJ-Robert Wood Johnson Medical School
Camden, United States
Mount Sinai School of Medicine (Jersey City Program)
Jersey City, United States
Joseph Schwab, M.D. principal investigator
New Jersey Medical School
14 sites in 1 country: see every site and its status.
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.