Alcohol AbuseNCT01881841
Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
A study testing cMET in people with Alcohol Abuse and Tobacco Use Disorder, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Alcohol Abuse, Tobacco Use Disorder, Substance Use
- What is being tested?
- cMET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2017
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14- to 20- yr-olds
- arriving for routine care to one of our participating pediatric practices (Lexington Pediatrics, Lexington, MA; East Boston Community Health Center, Longwood Pediatrics, Tufts Medical Center Adolescent Clinic, Boston, MA; Cambridge Health Alliance Dept. of Pediatrics, Cambridge, MA)
- any alcohol use days in the past 90 days,
- have an email address and internet access at home, school, or library
- provide informed assent/consent.
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 the time of the visit.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
John R Knight, MD, 617-355-5433, john.knight@childrens.harvard.edu
Melissa M Weiksnar, MS, MBA, 857-218-4311, melissa.weiksnar@childrens.harvard.edu
About this study
The goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care.
Read the detailed description
The study aims are to:
- Assess cMET feasibility and acceptability and estimate its effect size on underage drinking. Hypothesis: Among 14- to 20-yr-old primary care patients, those receiving cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual.
- Estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems.
- Identify potential moderators and mediators of cMET's effect.
- Conditions
- Alcohol Abuse, Tobacco Use Disorder, Substance Use
- Being tested
- cMET
- Keywords
- Alcohol abuse, Substance use, Tobacco use disorder, Motivational Enhancement Therapy, Adolescents
- Medical subject headings
- Alcoholism, 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.
cMETBehavioural
Also called Computerized Motivational Enhancement Therapy intervention
Those in cMET complete the 2-session self-administered computerized intervention which includes 8 exercises designed to encourage adolescents to evaluate the impact of alcohol and other substance use on their health and well-being and consider changing their use.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | Those randomized to Treatment as Usual (TAU) will not complete cMET but will receive standard treatment from the doctor. |
| cMET | Experimental | Those randomized to cMET will complete a 2-session computerized Motivational Enhancement Therapy (cMET) intervention. Receives: Behavioral: cMET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
The study investigators will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.
Measured: up to 9-months follow-up
Secondary outcomes (1)
Drinks per drinking day
The study investigators will measure the number of drinks per drinking day in the past 90 days at 3-, 6-, and 9-months follow-up
Measured: up to 9-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJan 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sion Kim Harris, Boston Children's Hospital
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's HospitalSion K Harris, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881841
- Sponsor's protocol ID
- JRKnightR34PA-13-078
- Status last verified
- Apr 2017
- First submitted
- 18 Jun 2013
- Last updated
- 20 Apr 2017
- 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 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
- ClinicalTrials.gov ID
- NCT01881841
- Acronym / sponsor ID
- JRKnightR34PA-13-078
- Conditions
- Alcohol Abuse, Tobacco Use Disorder, Substance Use
- Keywords
- Alcohol abuse, Substance use, Tobacco use disorder, Motivational Enhancement Therapy, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 20 Jun 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 evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care.
Detailed description
The study aims are to:
- Assess cMET feasibility and acceptability and estimate its effect size on underage drinking. Hypothesis: Among 14- to 20-yr-old primary care patients, those receiving cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual.
- Estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems.
- Identify potential moderators and mediators of cMET's effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –Those randomized to Treatment as Usual (TAU) will not complete cMET but will receive standard treatment from the doctor. |
| cMET | Experimental | Behavioral: cMETThose randomized to cMET will complete a 2-session computerized Motivational Enhancement Therapy (cMET) intervention. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 14- to 20- yr-olds
- arriving for routine care to one of our participating pediatric practices (Lexington Pediatrics, Lexington, MA; East Boston Community Health Center, Longwood Pediatrics, Tufts Medical Center Adolescent Clinic, Boston, MA; Cambridge Health Alliance Dept. of Pediatrics, Cambridge, MA)
- any alcohol use days in the past 90 days,
- have an email address and internet access at home, school, or library
- provide informed assent/consent.
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 the time of the 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 |
|---|---|---|
| cMETAlso: Computerized Motivational Enhancement Therapy interventionThose in cMET complete the 2-session self-administered computerized intervention which includes 8 exercises designed to encourage adolescents to evaluate the impact of alcohol and other substance use on their health and well-being and consider changing their use. | Behavioural | cMET |
Primary outcome
Alcohol use
Time frame: up to 9-months follow-up
The study investigators will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.
1 secondary outcome
Drinks per drinking day
Time frame: up to 9-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Web site of the Center for Adolescent Substance Abuse Research at Boston Children's HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Alcohol Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
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
Sion K Harris, PhD 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 cMET in people with Alcohol Abuse and Tobacco Use Disorder, 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 5 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John R Knight, MD (617-355-5433, john.knight@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: up to 9-months follow-up). 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 20 Apr 2017.