Underage DrinkingNCT01690026
Facilitating Adolescent Self-Change for Alcohol Problems
A study testing Motivation interviewing based brief intervention and Standard Intervention in people with Underage Drinking, run by University of California, San Diego at 3 sites in United States.
Trial summary
This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Underage Drinking
- What is being tested?
- Motivation interviewing based brief intervention and Standard Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,209 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to 30 Jun 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All 9th-12th graders at six schools from 3 sites across the country are eligible to participate, regardless of alcohol experience
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Drug Free Youth in Town
Miami, Florida, 33157-3459
University of Minnesota
Minneapolis, Minnesota, 55454-1495
Reed College
Portland, Oregon, 97202-8199
About this study
This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.
- Conditions
- Underage Drinking
- Being tested
- Motivation interviewing based brief intervention, Standard Intervention
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation interviewing based brief interventionBehavioural
Standard InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention | Other | Motivational intervention based brief intervention Receives: Behavioral: Motivation interviewing based brief intervention |
| Standard intervention | Other | Standard intervention condition Receives: Behavioral: Standard Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use and problems
Measured: one year
Secondary outcomes (1)
Cognitive mediators
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underage DrinkingStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Brown, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690026
- Sponsor's protocol ID
- Project Options
- Status last verified
- Nov 2017
- First submitted
- 12 Sep 2012
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Adolescent Self-Change for Alcohol Problems
- ClinicalTrials.gov ID
- NCT01690026
- Acronym / sponsor ID
- Project Options
- Conditions
- Underage Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,209 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 21 Sep 2012 (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.
This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief intervention | Other | Behavioral: Motivation interviewing based brief interventionMotivational intervention based brief intervention |
| Standard intervention | Other | Behavioral: Standard InterventionStandard intervention condition |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All 9th-12th graders at six schools from 3 sites across the country are eligible to participate, regardless of alcohol experience
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motivation interviewing based brief intervention | Behavioural | Brief intervention |
| Standard Intervention | Behavioural | Standard intervention |
Primary outcome
Alcohol use and problems
Time frame: one year
1 secondary outcome
Cognitive mediators
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivation interviewing based brief intervention and Standard Intervention in people with Underage Drinking, run by University of California, San Diego at 3 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alcohol use and problems (time frame: one year). 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 6 Nov 2017.