Tobacco AbusePhase 1/2NCT01275391
cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
A Phase 1/2 study testing Computer Screening, Brief Intervention, Referral toTreatment in people with Tobacco Abuse and Alcohol Abuse, run by Boston Children's Hospital at 1 site in United States.
Trial summary
In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Tobacco Abuse, Alcohol Abuse, Drug Abuse
- What is being tested?
- Computer Screening, Brief Intervention, Referral toTreatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 1/2
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-21 years of age
- arriving for routine care to dental office
Who cannot join
- dentally, medically, or psychologically unstable at the time of the visit
- cannot read or understand English at a 6th grade level
- unavailable for 1-month post-visit assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.
Read the detailed description
The goal of this project is to prepare for a large multi-site comparative effectiveness trial of a behavioral intervention, computer-facilitated Screening, Brief Intervention, and Referral to Treatment (cSBIRT) system that targets tobacco, alcohol, and drug use among adolescent dental patients. This enhanced computerized screening system includes: (1) screening, feedback, and provider talking points for tobacco and non-medical use of prescription drugs, (2) an interactive 2-part Motivational Enhancement Therapy module for adolescents at highest risk to complete from home, and (3) technological extenders (TEs), which are computer-generated messages that the provider sends to adolescents during the months following the clinic visit to reinforce the effect of the intervention over time.
- Conditions
- Tobacco Abuse, Alcohol Abuse, Drug Abuse
- Being tested
- Computer Screening, Brief Intervention, Referral toTreatment
- Keywords
- Tobacco use, Alcohol abuse, Drug abuse, Substance use, Prevention, Brief intervention, Screening, Adolescents
- Medical subject headings
- Tobacco Use Disorder, Alcoholism, Substance-Related Disorders, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Screening, Brief Intervention, Referral toTreatmentBehavioural
Also called Brief Advice, SBIRT, Screen and Brief Advice
A computerized screening for tobacco, alcohol and drug use accompanied by 10-15 pages of health information regarding the risks of tobacco, alcohol and drug use. This is followed by a brief conversation with the primary care provider regarding the health risks of tobacco, alcohol and drug use and a referral to treatment for those at high risk of substance use problems.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual Group 1 | No intervention | Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment |
| Treatment as Usual Group 2 | No intervention | Participants will receive treatment as usual and complete only the 1-month post-visit assessment |
| Intervention Group 1 | Experimental | Computer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment Receives: Behavioral: Computer Screening, Brief Intervention, Referral toTreatment |
| Intervention Group 2 | Experimental | Computer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment Receives: Behavioral: Computer Screening, Brief Intervention, Referral toTreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent of tobacco, alcohol and drugs
Measured: Past 90 days
Secondary outcomes (1)
Prevalence of tobacco, alcohol and drug use
Measured: Past 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2013 (estimated)
- Study completionSep 2013 (estimated)
Why it stopped: This project was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pearl Network
- Responsible party
- Principal investigator, John R Knight, MD, Boston Children's Hospital
- Investigators
- John R. Knight, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275391
- Sponsor's protocol ID
- RFADEcSBIRT
- Status last verified
- Oct 2016
- First submitted
- 11 Jan 2011
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
- ClinicalTrials.gov ID
- NCT01275391
- Acronym / sponsor ID
- RFADEcSBIRT
- Conditions
- Tobacco Abuse, Alcohol Abuse, Drug Abuse
- Keywords
- Tobacco use, Alcohol abuse, Drug abuse, Substance use, Prevention, Brief intervention, Screening, Adolescents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This project was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Pearl Network
- Study start
- Sep 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 12 Jan 2011 (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.
In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.
Detailed description
The goal of this project is to prepare for a large multi-site comparative effectiveness trial of a behavioral intervention, computer-facilitated Screening, Brief Intervention, and Referral to Treatment (cSBIRT) system that targets tobacco, alcohol, and drug use among adolescent dental patients. This enhanced computerized screening system includes: (1) screening, feedback, and provider talking points for tobacco and non-medical use of prescription drugs, (2) an interactive 2-part Motivational Enhancement Therapy module for adolescents at highest risk to complete from home, and (3) technological extenders (TEs), which are computer-generated messages that the provider sends to adolescents during the months following the clinic visit to reinforce the effect of the intervention over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual Group 1 | No intervention | –Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment |
| Treatment as Usual Group 2 | No intervention | –Participants will receive treatment as usual and complete only the 1-month post-visit assessment |
| Intervention Group 1 | Experimental | Behavioral: Computer Screening, Brief Intervention, Referral toTreatmentComputer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment |
| Intervention Group 2 | Experimental | Behavioral: Computer Screening, Brief Intervention, Referral toTreatmentComputer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 12-21 years of age
- arriving for routine care to dental office
Key exclusion criteria (3 listed)
- dentally, medically, or psychologically unstable at the time of the visit
- cannot read or understand English at a 6th grade level
- unavailable for 1-month post-visit assessment
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 |
|---|---|---|
| Computer Screening, Brief Intervention, Referral toTreatmentAlso: Brief Advice, SBIRT, Screen and Brief AdviceA computerized screening for tobacco, alcohol and drug use accompanied by 10-15 pages of health information regarding the risks of tobacco, alcohol and drug use. This is followed by a brief conversation with the primary care provider regarding the health risks of tobacco, alcohol and drug use and a referral to treatment for those at high risk of substance use problems. | Behavioural | Intervention Group 1, Intervention Group 2 |
Primary outcome
Percent days abstinent of tobacco, alcohol and drugs
Time frame: Past 90 days
1 secondary outcome
Prevalence of tobacco, alcohol and drug use
Time frame: Past 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Derived from this study: PubMed 33605440Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
- web site of the Center for Adolescent Substance Abuse Research at Children's Hospital BostonLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tobacco Abuse
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Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
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Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
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Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
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The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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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.
John R. Knight, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Computer Screening, Brief Intervention, Referral toTreatment in people with Tobacco Abuse and Alcohol Abuse, run by Boston Children's Hospital at 1 site 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?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent days abstinent of tobacco, alcohol and drugs (time frame: Past 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275391, which also lists 1 linked publication.
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 7 Oct 2016.