Alcohol AbusePhase 1NCT01784627
Trial of Computerized SBI to Reduce Teen Alcohol Use
A Phase 1 study testing c-ASBI in people with Alcohol Abuse and Cannabis Abuse, run by Boston Children's Hospital at 6 sites in United States.
Trial summary
The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. Read more about this study
- Who is it for?
- Ages 9 to 20 years
- Conditions the study is for
- Alcohol Abuse, Cannabis Abuse, Nicotine Dependence
- What is being tested?
- c-ASBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2015to Oct 2017
- Phase
- Phase 1
- 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 9 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Arriving for well or non-emergent care at one of participating study sites
- Have an email address
- Have internet address
Who cannot join
- Unable to read or understand English
- Living away at college at the time of the recruitment visit
- Not available for computer/telephone follow-ups
- Judged by the provider to be medically or emotionally unstable at time of visit
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Boston Children's Hospital
Boston, Massachusetts, 02115
Longwood Pediatrics
Boston, Massachusetts, 02115
East Boston Neighborhood Health Center
Boston, Massachusetts, 02128
Cambridge Pediatrics
Cambridge, Massachusetts, 02139
Lexington Pediatrics
Lexington, Massachusetts, 02421
About this study
Official title: Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use
The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).
Read the detailed description
The Specific Aims are to 1) Test the effects of c-ASBI on any alcohol use; 2) Test the effects of c-ASBI separately as a prevention, therapeutic, and risk-reduction intervention; 3) Test the effects of c-ASBI separately on cannabis and tobacco use; explore its effects on other drug use; and 4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Youth to Provider Connectedness,20 perceived harmfulness of alcohol and drug use), and explore c-ASBI's mechanism of action.
- Conditions
- Alcohol Abuse, Cannabis Abuse, Nicotine Dependence
- Being tested
- c-ASBI
- Keywords
- substance use, alcohol abuse, cannabis abuse, nicotine dependence, adolescents
- Medical subject headings
- Alcoholism, Marijuana Abuse, Tobacco Use Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-ASBIBehavioural
Participants in the c-ASBI group will complete a computerized screen for alcohol, cannabis, tobacco and other drugs, then view their screen score and 10 pages of information about the health effects of substance use and true-life stories on the computer. Their provider will see a report of their screen results and provide advice to stop or decrease their use, or, for those at high risk, referral to complete a computerized motivational enhancement therapy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment at Usual | No intervention | Participants in this group will receive treatment as usual (TAU) from their provider, which may or may not include screening and brief advice regarding alcohol use. |
| c-ASBI | Experimental | Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI). Receives: Behavioral: c-ASBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of alcohol use
We will compare rates of any alcohol use over the past twelve months between the groups.
Measured: 12 months
Secondary outcomes (3)
Drinking initiation
We will compare rates of drinking initiation over the past 12-months between groups.
Measured: 12 months
Drinking cessation
We will compare rates of drinking cessation over the past 12 months between groups.
Measured: 12 months
Driving/Riding risk
We will compare the rates of driving under the influence or riding with a driver under the influence between groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startJan 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: No funding
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 1
- Primary purpose
- Prevention
- 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
- 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
- NCT01784627
- Sponsor's protocol ID
- JK R01 PA-12-031
- Status last verified
- Oct 2016
- First submitted
- 4 Feb 2013
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- 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
- Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use
- ClinicalTrials.gov ID
- NCT01784627
- Acronym / sponsor ID
- JK R01 PA-12-031
- Conditions
- Alcohol Abuse, Cannabis Abuse, Nicotine Dependence
- Keywords
- substance use, alcohol abuse, cannabis abuse, nicotine dependence, adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 6 Feb 2013 (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 test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).
Detailed description
The Specific Aims are to 1) Test the effects of c-ASBI on any alcohol use; 2) Test the effects of c-ASBI separately as a prevention, therapeutic, and risk-reduction intervention; 3) Test the effects of c-ASBI separately on cannabis and tobacco use; explore its effects on other drug use; and 4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Youth to Provider Connectedness,20 perceived harmfulness of alcohol and drug use), and explore c-ASBI's mechanism of action.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment at Usual | No intervention | –Participants in this group will receive treatment as usual (TAU) from their provider, which may or may not include screening and brief advice regarding alcohol use. |
| c-ASBI | Experimental | Behavioral: c-ASBIParticipants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI). |
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Arriving for well or non-emergent care at one of participating study sites
- Have an email address
- Have internet address
Key exclusion criteria (4 listed)
- Unable to read or understand English
- Living away at college at the time of the recruitment visit
- Not available for computer/telephone follow-ups
- Judged by the provider to be medically or emotionally unstable at time of visit
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 |
|---|---|---|
| c-ASBIParticipants in the c-ASBI group will complete a computerized screen for alcohol, cannabis, tobacco and other drugs, then view their screen score and 10 pages of information about the health effects of substance use and true-life stories on the computer. Their provider will see a report of their screen results and provide advice to stop or decrease their use, or, for those at high risk, referral to complete a computerized motivational enhancement therapy intervention. | Behavioural | c-ASBI |
Primary outcome
Days of alcohol use
Time frame: 12 months
We will compare rates of any alcohol use over the past twelve months between the groups.
3 secondary outcomes
Drinking initiation
Time frame: 12 months
Drinking cessation
Time frame: 12 months
Driving/Riding risk
Time frame: 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.
- 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing c-ASBI in people with Alcohol Abuse and Cannabis Abuse, run by Boston Children's Hospital at 6 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?
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 6 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 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.
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?
Days of alcohol use (time frame: 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.