Alcohol DrinkingPhase 2CHOICENCT01081119
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
A Phase 2 study testing Project CHOICE in people with Alcohol Drinking and Cigarette Smoking, run by RAND at 1 site in United States.
Trial summary
We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Alcohol Drinking, Cigarette Smoking, Marijuana Smoking
- What is being tested?
- Project CHOICE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,455 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2014
- 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 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
16 middle schools in Torrance, Santa Monica, and Los Angeles
Los Angeles, California
About this study
We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use. We are conducting surveys in all schools over three years and providing the intervention in 8 schools in the 2008-2009 school year and in the other 8 schools in the 2011-2012 school year. This is a program we have provided before in middle schools and we found that it was effective in curbing alcohol and drug use among students who voluntarily attended and among all students at the intervention school.
Read the detailed description
The middle school years are peak years for initiation of alcohol and marijuana (Johnston et al., 2007). Unfortunately, most youth who engage in substance use and experience problems are unlikely to voluntarily make use of formal prevention services (D'Amico, 2005; Johnson et al., 2001; Wu et al., 2003). A small body of recent research suggests that youth may benefit from less formal programs that are brief, voluntary, and easily accessible (Brown, 2001; D'Amico et al., 2005). However, very few intervention programs of this type have been developed (Little and Harris, 2003). Thus, while this approach shows promise, the impact of intervention programs that younger teens may choose to attend has not been extensively examined. One such intervention, Project CHOICE, was developed and tested by the PI using NIAAA funding for developmental work (R21AA13284). Project CHOICE is the only voluntary intervention that has been tested for middle school youth and our small quasi-experimental study has demonstrated its efficacy in one school setting (D'Amico and Edelen, in press; D'Amico et al., 2005). The Project CHOICE intervention addresses several critical gaps in the field, including beginning to understand voluntary service utilization among this age group and assessing how this type of program may impact school-wide use of alcohol and other drugs (AOD). The main objective of the proposed 5-year longitudinal study is to build on our initial work by conducting a more rigorous test of Project CHOICE. The study will include 16 middle schools, located in the ethnically diverse Southern California cities of Los Angeles, Santa Monica, and Torrance. These schools will be randomly assigned as intervention (n= 8) or control (n = 8). We will first examine individual-level effects by testing whether Project CHOICE affects AOD-related outcomes among students who participate in the intervention. We will then examine school-level effects by testing whether AOD rates among all students in the intervention schools are affected, regardless of participation. We assume that these school-level effects will be due to changes in the school environment (e.g., Project CHOICE advertising, discussion of Project CHOICE among students, changes in social norms). In anticipation of this school-level impact, a secondary objective of this study is to gain a better understanding of who participates in Project CHOICE, as well as how these participants and changes in the school environment may influence the attitudes and behaviors of those who do not participate. This research incorporates a novel methodology for AOD involvement, as it emphasizes personal self-change efforts and natural recovery and is appealing to both using and non-using youth. The work proposed in this application represents the important next step in this line of research: to more critically evaluate Project CHOICE and its potential impact on both school-wide and individual outcomes with a larger population of youth.
- Conditions
- Alcohol Drinking, Cigarette Smoking, Marijuana Smoking
- Being tested
- Project CHOICE
- Keywords
- adolescent, middle school, prevention, alcohol, cigarettes, marijuana
- Medical subject headings
- Alcohol Drinking, Cigarette Smoking, Marijuana Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project CHOICEBehavioural
Voluntary after school program offered 1 day per week for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Project CHOICE | Experimental | Middle school receives Project CHOICE Receives: Behavioral: Project CHOICE |
| No Project CHOICE | No intervention | Middle school does not receive Project CHOICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol, cigarette, and marijuana use
Measured: 3 years
Secondary outcomes (1)
Substance use-related cognitions
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startSep 2008
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. D'Amico, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081119
- Sponsor's protocol ID
- R01AA016577
- Acronym
- CHOICE
- Status last verified
- Jul 2014
- First submitted
- 3 Mar 2010
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
- ClinicalTrials.gov ID
- NCT01081119
- Acronym / sponsor ID
- CHOICE / R01AA016577
- Conditions
- Alcohol Drinking, Cigarette Smoking, Marijuana Smoking
- Keywords
- adolescent, middle school, prevention, alcohol, cigarettes, marijuana
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,455 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Mar 2010 (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.
We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use. We are conducting surveys in all schools over three years and providing the intervention in 8 schools in the 2008-2009 school year and in the other 8 schools in the 2011-2012 school year. This is a program we have provided before in middle schools and we found that it was effective in curbing alcohol and drug use among students who voluntarily attended and among all students at the intervention school.
Detailed description
The middle school years are peak years for initiation of alcohol and marijuana (Johnston et al., 2007). Unfortunately, most youth who engage in substance use and experience problems are unlikely to voluntarily make use of formal prevention services (D'Amico, 2005; Johnson et al., 2001; Wu et al., 2003). A small body of recent research suggests that youth may benefit from less formal programs that are brief, voluntary, and easily accessible (Brown, 2001; D'Amico et al., 2005). However, very few intervention programs of this type have been developed (Little and Harris, 2003). Thus, while this approach shows promise, the impact of intervention programs that younger teens may choose to attend has not been extensively examined. One such intervention, Project CHOICE, was developed and tested by the PI using NIAAA funding for developmental work (R21AA13284). Project CHOICE is the only voluntary intervention that has been tested for middle school youth and our small quasi-experimental study has demonstrated its efficacy in one school setting (D'Amico and Edelen, in press; D'Amico et al., 2005). The Project CHOICE intervention addresses several critical gaps in the field, including beginning to understand voluntary service utilization among this age group and assessing how this type of program may impact school-wide use of alcohol and other drugs (AOD). The main objective of the proposed 5-year longitudinal study is to build on our initial work by conducting a more rigorous test of Project CHOICE. The study will include 16 middle schools, located in the ethnically diverse Southern California cities of Los Angeles, Santa Monica, and Torrance. These schools will be randomly assigned as intervention (n= 8) or control (n = 8). We will first examine individual-level effects by testing whether Project CHOICE affects AOD-related outcomes among students who participate in the intervention. We will then examine school-level effects by testing whether AOD rates among all students in the intervention schools are affected, regardless of participation. We assume that these school-level effects will be due to changes in the school environment (e.g., Project CHOICE advertising, discussion of Project CHOICE among students, changes in social norms). In anticipation of this school-level impact, a secondary objective of this study is to gain a better understanding of who participates in Project CHOICE, as well as how these participants and changes in the school environment may influence the attitudes and behaviors of those who do not participate. This research incorporates a novel methodology for AOD involvement, as it emphasizes personal self-change efforts and natural recovery and is appealing to both using and non-using youth. The work proposed in this application represents the important next step in this line of research: to more critically evaluate Project CHOICE and its potential impact on both school-wide and individual outcomes with a larger population of youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project CHOICE | Experimental | Behavioral: Project CHOICEMiddle school receives Project CHOICE |
| No Project CHOICE | No intervention | –Middle school does not receive Project CHOICE |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 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 |
|---|---|---|
| Project CHOICEVoluntary after school program offered 1 day per week for 30 minutes | Behavioural | Project CHOICE |
Primary outcome
Alcohol, cigarette, and marijuana use
Time frame: 3 years
1 secondary outcome
Substance use-related cognitions
Time frame: 3 years
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 10 Jul 2014.
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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.
Elizabeth J. D'Amico, PhD principal investigator
RAND
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 Project CHOICE in people with Alcohol Drinking and Cigarette Smoking, run by RAND 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 0 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 10 Jul 2014. 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?
Alcohol, cigarette, and marijuana use (time frame: 3 years). 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 10 Jul 2014.