Alcohol AbuseNCT01796158
Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use
A study testing cASBI+cMET and cASBI in people with Alcohol Abuse, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- cASBI+cMET and cASBI
- 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 2013to Mar 2016
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- any alcohol use days in the past 90 days
- have an email address and internet access at home, school, or library
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
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Pilot Test of Computerized MET Intervention to Reduce Adolescent Alcohol Use
The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.
Read the detailed description
The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients. The investigators hypothesize that 1) cMET, when added to Computerized Alcohol Screening and Brief Intervention (cASBI), (cASBI+cMET) will be feasible and acceptable when used in primary care; and 2) 12- to 18-yr old patients receiving cASBI+cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than cASBI alone.
- Conditions
- Alcohol Abuse
- Being tested
- cASBI+cMET, cASBI
- Keywords
- adolescents, alcohol abuse, drug abuse, substance use
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cASBI+cMETBehavioural
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. The cMET protocol is a 2 session intervention composed of 8 exercises designed to encourage adolescents their alcohol and other substance use and develop a plan to stop or reduce their use.
cASBIBehavioural
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.
| Study group | Role | What they receive |
|---|---|---|
| cASBI+cMET | Experimental | Participants will complete the computerized alcohol screening and brief intervention (cASBI)protocol at the time of an office visit and also complete the 2-session computerized Motivational Enhancement Therapy intervention (cMET). Receives: Behavioral: cASBI+cMET; Behavioral: cASBI |
| cASBI | Active comparator | Participants will complete the computerized screening and brief intervention protocol at the time of a primary care office visit. Receives: Behavioral: cASBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
cMET completion
The investigators will measure the percentages of completed cMET sessions by those referred to cMET.
Measured: Baseline
Secondary outcomes (1)
cMET satisfaction
The investigators will measure patient satisfaction with the cMET program.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: 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
- Treatment
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796158
- Sponsor's protocol ID
- JKR34_PA-13-078
- Status last verified
- Oct 2016
- First submitted
- 20 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
- Pilot Test of Computerized MET Intervention to Reduce Adolescent Alcohol Use
- ClinicalTrials.gov ID
- NCT01796158
- Acronym / sponsor ID
- JKR34_PA-13-078
- Conditions
- Alcohol Abuse
- Keywords
- adolescents, alcohol abuse, drug abuse, substance use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 21 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 conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.
Detailed description
The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients. The investigators hypothesize that 1) cMET, when added to Computerized Alcohol Screening and Brief Intervention (cASBI), (cASBI+cMET) will be feasible and acceptable when used in primary care; and 2) 12- to 18-yr old patients receiving cASBI+cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than cASBI alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cASBI+cMET | Experimental | Behavioral: cASBI+cMET, Behavioral: cASBIParticipants will complete the computerized alcohol screening and brief intervention (cASBI)protocol at the time of an office visit and also complete the 2-session computerized Motivational Enhancement Therapy intervention (cMET). |
| cASBI | Active comparator | Behavioral: cASBIParticipants will complete the computerized screening and brief intervention protocol at the time of a primary care office visit. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- any alcohol use days in the past 90 days
- have an email address and internet access at home, school, or library
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 |
|---|---|---|
| cASBI+cMETIn the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. The cMET protocol is a 2 session intervention composed of 8 exercises designed to encourage adolescents their alcohol and other substance use and develop a plan to stop or reduce their use. | Behavioural | cASBI+cMET |
| cASBIIn the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. | Behavioural | cASBI, cASBI+cMET |
Primary outcome
cMET completion
Time frame: Baseline
The investigators will measure the percentages of completed cMET sessions by those referred to cMET.
1 secondary outcome
cMET satisfaction
Time frame: 9 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cASBI+cMET and cASBI in people with 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 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?
cMET completion (time frame: Baseline). 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.