Alcohol-related DisordersPhase 2AlcoholINETNCT01847183
Evaluation of an School-based Alcohol Prevention Program for Middle School Students
A Phase 2 study testing Click City®: Alcohol in people with Alcohol-related Disorders and Drinking and Driving, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this research is to create and evaluate the efficacy of an exciting (fun to use), and potentially disseminable computer-based prevention program, Click City®: Alcohol, for use by 7th graders with a booster in 8th grade students. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Alcohol-related Disorders, Drinking and Driving, Neurological Impairment
- What is being tested?
- Click City®: Alcohol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2016
- Phase
- Phase 2
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parents give passive consent for their students to participate. Students must attend a participating school.
Who cannot join
- non-English speakers, some special Ed students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Intranet-Based Alcohol Prevention Program in Middle School
The purpose of this research is to create and evaluate the efficacy of an exciting (fun to use), and potentially disseminable computer-based prevention program, Click City®: Alcohol, for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high school. Secondary goals of the program include decreasing students' intentions and willingness to engage in heavy drinking in high school. The proposed program is unique both in its delivery system and the development process.
Aim 1: The investigators plan to develop and test approximately 24 components over the first two years of the study.
Read more
Aim 2: The final Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period in 7th grade. This is followed by two booster sessions, consisting of a total of 5 components delivered over a one-week period in 8th grade. Educational newsletters to parents and teacher guides will accompany the program.
Aim 3: Following development, the investigators will conduct a group randomized trial to evaluate the efficacy of this program as compared to schools' usual alcohol prevention curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle schools to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC). Students in the Click City®: Alcohol and yoked UC schools will be assessed prior to the beginning of the 7th grade program, following the 7th grade program, following the 8th grade booster, which would occur approximately one year after the 7th grade program, and a follow-up assessment in the 9th grade to assess long-term outcomes, one year after the 8th grade assessment.
Read the detailed description
The proposed program is unique both in its delivery system and the development process. The program will be delivered in a computer game like format over a school-based intranet system (i.e., networked computers linked to a school-based server), which enables users to interact individually with the program and to share their experiences by receiving immediate feedback on both their own responses and those of their classmates' collective responses. The delivery of this computer-based programs assures fidelity of implementation. Each activity (component) ultimately included in the program will be continually developed and tested to assure that it is effective at changing the targeted theoretically based etiological mechanism (risk factor). Development will include an experimental assessment to evaluate the effectiveness of each component and only effective components will be included in the program. The 7th grade version of Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period. This will be followed by two 8th grade booster sessions, consisting of a total of 5 components delivered over a one-week period. Educational newsletters to parents and teacher guides will be developed to accompany the program. The investigators will conduct a randomized efficacy trial with 26 middle schools. Half of the schools will use the newly developed program and the other half will use the programs that they usually do to teach about Alcohol.
- Being tested
- Click City®: Alcohol
- Keywords
- heavy drinking, prevention, high school, adolescence
- Medical subject headings
- Alcohol-Related Disorders, Driving Under the Influence, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Click City®: AlcoholBehavioural
A school based program, Click City®: Alcohol consists of 12 effective components delivered in 7th grade and a booster of 5 effective components delivered in 8th grade.
| Study group | Role | What they receive |
|---|---|---|
| Click City®: Alcohol | Experimental | Receive the Click City®: Alcohol program as part of their school curriculum. Receives: Behavioral: Click City®: Alcohol |
| Usual Curriculum | No intervention | Students receive their usual alcohol curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease intentions to get drunk from baseline to one week follow-up; from baseline to one-year follow-up and from baseline to two-year followup.
Intention is measured by two items:
Do you think you will get drunk (from drinking too much alcohol) when you are in high school? Do you think you will get drunk (from drinking too much alcohol) when you are older?
Measured: one week following intervention; one year following intervention: two years following intervention
Secondary outcomes (1)
Decrease willingness to get drink alcohol from baseline
Willingness is measured by:
This is a "suppose" question. Think about yourself in this situation. We are not saying that you would be in this situation. We just want you to think about it, then tell us how you would act. Suppose you were with a group of friends and there was some alcohol there and you could have it if you wanted. How willing would you be to do each of the following:
(check on Not at all willing, a little willing, kind of willing, pretty willing, very willing)
- Drink one drink
- Drink more than one drink
- Drink enough to get buzzed
- Drink enough to get drunk
Measured: one week following intervention; one year following intervention: two years following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-related DisordersStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Judy Andrews, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847183
- Sponsor's protocol ID
- AA019671
- Other IDs
- R01AA019671
- Acronym
- AlcoholINET
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2013
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intranet-Based Alcohol Prevention Program in Middle School
- ClinicalTrials.gov ID
- NCT01847183
- Acronym / sponsor ID
- AlcoholINET / AA019671
- Keywords
- heavy drinking, prevention, high school, adolescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 May 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 purpose of this research is to create and evaluate the efficacy of an exciting (fun to use), and potentially disseminable computer-based prevention program, Click City®: Alcohol, for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high school. Secondary goals of the program include decreasing students' intentions and willingness to engage in heavy drinking in high school. The proposed program is unique both in its delivery system and the development process.
Aim 1: The investigators plan to develop and test approximately 24 components over the first two years of the study.
Aim 2: The final Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period in 7th grade. This is followed by two booster sessions, consisting of a total of 5 components delivered over a one-week period in 8th grade. Educational newsletters to parents and teacher guides will accompany the program.
Aim 3: Following development, the investigators will conduct a group randomized trial to evaluate the efficacy of this program as compared to schools' usual alcohol prevention curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle schools to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC). Students in the Click City®: Alcohol and yoked UC schools will be assessed prior to the beginning of the 7th grade program, following the 7th grade program, following the 8th grade booster, which would occur approximately one year after the 7th grade program, and a follow-up assessment in the 9th grade to assess long-term outcomes, one year after the 8th grade assessment.
Detailed description
The proposed program is unique both in its delivery system and the development process. The program will be delivered in a computer game like format over a school-based intranet system (i.e., networked computers linked to a school-based server), which enables users to interact individually with the program and to share their experiences by receiving immediate feedback on both their own responses and those of their classmates' collective responses. The delivery of this computer-based programs assures fidelity of implementation. Each activity (component) ultimately included in the program will be continually developed and tested to assure that it is effective at changing the targeted theoretically based etiological mechanism (risk factor). Development will include an experimental assessment to evaluate the effectiveness of each component and only effective components will be included in the program. The 7th grade version of Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period. This will be followed by two 8th grade booster sessions, consisting of a total of 5 components delivered over a one-week period. Educational newsletters to parents and teacher guides will be developed to accompany the program. The investigators will conduct a randomized efficacy trial with 26 middle schools. Half of the schools will use the newly developed program and the other half will use the programs that they usually do to teach about Alcohol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Click City®: Alcohol | Experimental | Behavioral: Click City®: AlcoholReceive the Click City®: Alcohol program as part of their school curriculum. |
| Usual Curriculum | No intervention | –Students receive their usual alcohol curriculum |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents give passive consent for their students to participate. Students must attend a participating school.
Key exclusion criteria (1 listed)
- non-English speakers, some special Ed students
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 |
|---|---|---|
| Click City®: AlcoholA school based program, Click City®: Alcohol consists of 12 effective components delivered in 7th grade and a booster of 5 effective components delivered in 8th grade. | Behavioural | Click City®: Alcohol |
Primary outcome
Decrease intentions to get drunk from baseline to one week follow-up; from baseline to one-year follow-up and from baseline to two-year followup.
Time frame: one week following intervention; one year following intervention: two years following intervention
Intention is measured by two items: Do you think you will get drunk (from drinking too much alcohol) when you are in high school? Do you think you will get drunk (from drinking too much alcohol) when you are older?
1 secondary outcome
Decrease willingness to get drink alcohol from baseline
Time frame: one week following intervention; one year following intervention: two years following intervention
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 Oct 2016.
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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.
Judy Andrews, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Click City®: Alcohol in people with Alcohol-related Disorders and Drinking and Driving, run by Oregon Research Institute 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 1 inclusion and 1 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Decrease intentions to get drunk from baseline to one week follow-up; from baseline to one-year follow-up and from baseline to two-year followup. (time frame: one week following intervention; one year following intervention: two years following intervention). 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 Oct 2016.