Alcohol AbuseNCT00849589
Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
A study testing Computerized screening and brief physician advice and Computerized SBA with technological extenders in people with Alcohol Abuse and Risk Behavior, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Risk Behavior
- What is being tested?
- Computerized screening and brief physician advice and Computerized SBA with technological extenders
- 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
- Jan 2010to Dec 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12-21 years old
- patients arriving for routine medical care
- provide informed assent (for those <18) or informed consent (for those 18-21)
Who cannot join
- medically or psychologically unstable at time of visit
- receiving behavioral health services
- cannot read or understand English at a 6th grade reading level
- unavailable for follow-up assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).
Read the detailed description
The specific aims of the proposed multisite RCT are:
- To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
- To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
- To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
- To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.
- Conditions
- Alcohol Abuse, Risk Behavior
- Being tested
- Computerized screening and brief physician advice, Computerized SBA with technological extenders
- Keywords
- Screening, Brief intervention, Underage drinking
- Medical subject headings
- Alcoholism, Risk-Taking, Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized screening and brief physician adviceBehavioural
Also called Screening, Brief advice, Brief intervention, Underage drinking
Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors
Computerized SBA with technological extendersBehavioural
Also called Screening, Brief advice, Brief intervention, Underage drinking
Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors. In addition, the provider sends them a brief email or text message at 4 months and 9 months after study entry to reinforce the brief advice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Treatment as Usual (TAU) |
| 2 | Experimental | Computerized Screening and Brief Physician Advice (SBA) Receives: Behavioral: Computerized screening and brief physician advice |
| 3 | Experimental | Computerized screening and brief physician advice with technological extenders (SBA/TE) Receives: Behavioral: Computerized SBA with technological extenders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of underage drinking
Measured: Baseline, 3-months, 6-months, 12-months
Secondary outcomes (1)
Cessation of underage drinking
Measured: Baseline, 3-months, 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Grant application was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Health Alliance, Dartmouth-Hitchcock Medical Center, Fallon Clinic, Tufts Medical Center, University of Vermont
- 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
- NCT00849589
- Sponsor's protocol ID
- PA-07-406
- Status last verified
- Oct 2016
- First submitted
- 23 Feb 2009
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
- ClinicalTrials.gov ID
- NCT00849589
- Acronym / sponsor ID
- PA-07-406
- Conditions
- Alcohol Abuse, Risk Behavior
- Keywords
- Screening, Brief intervention, Underage drinking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant application was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Cambridge Health Alliance, Dartmouth-Hitchcock Medical Center, Fallon Clinic, Tufts Medical Center, University of Vermont
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Feb 2009 (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 goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).
Detailed description
The specific aims of the proposed multisite RCT are:
- To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
- To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
- To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
- To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Treatment as Usual (TAU) |
| 2 | Experimental | Behavioral: Computerized screening and brief physician adviceComputerized Screening and Brief Physician Advice (SBA) |
| 3 | Experimental | Behavioral: Computerized SBA with technological extendersComputerized screening and brief physician advice with technological extenders (SBA/TE) |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 12-21 years old
- patients arriving for routine medical care
- provide informed assent (for those <18) or informed consent (for those 18-21)
Key exclusion criteria (4 listed)
- medically or psychologically unstable at time of visit
- receiving behavioral health services
- cannot read or understand English at a 6th grade reading level
- unavailable for follow-up assessments
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 |
|---|---|---|
| Computerized screening and brief physician adviceAlso: Screening, Brief advice, Brief intervention, Underage drinkingParticipants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors | Behavioural | 2 |
| Computerized SBA with technological extendersAlso: Screening, Brief advice, Brief intervention, Underage drinkingParticipants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors. In addition, the provider sends them a brief email or text message at 4 months and 9 months after study entry to reinforce the brief advice. | Behavioural | 3 |
Primary outcome
Initiation of underage drinking
Time frame: Baseline, 3-months, 6-months, 12-months
1 secondary outcome
Cessation of underage drinking
Time frame: Baseline, 3-months, 6-months, 12-months
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.
- Center for Adolescent Substance Abuse ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 study testing Computerized screening and brief physician advice and Computerized SBA with technological extenders in people with Alcohol Abuse and Risk Behavior, 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 3 inclusion and 4 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.
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?
Initiation of underage drinking (time frame: Baseline, 3-months, 6-months, 12-months). It is what the study was designed to measure, not a finding.
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 7 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.