Alcohol AbuseBriefNCT01427465
Brief Integrative Alcohol Interventions for Adolescents
A study testing Brief Prevention Program Using Positive Image in people with Alcohol Abuse and Drug Abuse, run by University of Florida at 1 site in United States.
Trial summary
The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse prevention strategies that integrate positive youth development messages and health risk messages for adolescents in high school settings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Drug Abuse
- What is being tested?
- Brief Prevention Program Using Positive Image
- 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 2007to Sep 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read English
- 10th and 11th grade high school students at participating sites
Who cannot join
- Cannot read English
- Not in 10th and 11th grade high school students at participating sites
Trial locations and contacts
1 site in 1 country.
United States1 site
Addictive & Health Behaviors Research Institute, University of Florida
Jacksonville, Florida, 32256
About this study
The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse prevention strategies that integrate positive youth development messages and health risk messages for adolescents in high school settings. A secondary aim is to examine these strategies in various combinations as interventions and re-interventions (i.e., boosters) for sustaining or enhancing behavior change over time. These strategies are founded upon an emerging conceptual framework titled the Behavior-Image Model emanating from findings of our recent trials examining multiple behavior health interventions. The long-term objective of this project is to reduce alcohol abuse and problems among older high-risk adolescents for whom alcohol and drug use disparities exist, yet who are often overlooked in prevention research and services.
Read the detailed description
A total of 921 adolescents from two diverse high schools in northeast Florida were randomized to receive either the: 1) in-person consult, 2) parent-youth letter, 3) adolescent newsletter, or 4) standard care control . Three-month, one-year and 18-month follow-ups are planned, with interventions to be implemented in rotating fashion as re-interventions immediately after three-month and one-year data collections. Plans for following year include the following: 1) collecting and analyzing 3-month post-intervention data to determine the effects of the initial consult, parent-youth and adolescent print strategies, intervention costs, and assess possible mediators and moderators of outcomes; 2) implementing the first round of re-interventions; 3) collecting and analyzing one-year post-baseline effects of re-interventions, determining costs and cost-effectiveness of the interventions/re-interventions, and assessing possible mediators and moderators of outcomes; and 4) implementing the second round of re-interventions.
- Conditions
- Alcohol Abuse, Drug Abuse
- Being tested
- Brief Prevention Program Using Positive Image
- Keywords
- Brief, Image, Intervention, Adolescents, School
- 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.
Brief Prevention Program Using Positive ImageBehavioural
Also called Consult
Consult
Brief Prevention Program Using Positive ImageBehavioural
Also called Control
Control - Standard of Care
Brief Prevention Program Using Positive ImageBehavioural
Also called Newsletter
Newsletter
Brief Prevention Program Using Positive ImageBehavioural
Also called Parent Letter
Parent Letter
| Study group | Role | What they receive |
|---|---|---|
| Consult | Experimental | Consult Receives: Behavioral: Brief Prevention Program Using Positive Image |
| Newsletter | Experimental | Newsletter Receives: Behavioral: Brief Prevention Program Using Positive Image |
| Parent Letter | Experimental | Parent Letter Receives: Behavioral: Brief Prevention Program Using Positive Image |
| Control | Active comparator | Control Receives: Behavioral: Brief Prevention Program Using Positive Image |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Measured: Baseline to 3 months follow up
Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up.
Measured: Baseline to 12 months follow up
Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up.
Measured: Baseline to 18 months follow up
Secondary outcomes (3)
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Measured: Baseline to 3 months follow up
Change in frequency of health promoting behaviors from baseline to 12 months follow up.
Measured: Baseline to 12 months follow up
Change in frequency of health promoting behaviors from baseline to 18 months follow up.
Measured: Baseline to 18 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 posted1 Sep 2011 (estimated)
- Study startSep 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: PI left University of Florida
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 University of FloridaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Chudley E Werch, PhD, Principal investigator, Addictive & Health Behaviors Research Institute, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427465
- Sponsor's protocol ID
- #2007-U-0085
- Other IDs
- R01AA009283
- Acronym
- Brief
- Status last verified
- Nov 2011
- First submitted
- 22 Jul 2010
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Integrative Alcohol Interventions for Adolescents
- ClinicalTrials.gov ID
- NCT01427465
- Acronym / sponsor ID
- Brief / #2007-U-0085
- Conditions
- Alcohol Abuse, Drug Abuse
- Keywords
- Brief, Image, Intervention, Adolescents, School
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left University of Florida
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Sep 2011 (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 primary aim of this research is to test the efficacy of innovative, brief alcohol abuse prevention strategies that integrate positive youth development messages and health risk messages for adolescents in high school settings. A secondary aim is to examine these strategies in various combinations as interventions and re-interventions (i.e., boosters) for sustaining or enhancing behavior change over time. These strategies are founded upon an emerging conceptual framework titled the Behavior-Image Model emanating from findings of our recent trials examining multiple behavior health interventions. The long-term objective of this project is to reduce alcohol abuse and problems among older high-risk adolescents for whom alcohol and drug use disparities exist, yet who are often overlooked in prevention research and services.
Detailed description
A total of 921 adolescents from two diverse high schools in northeast Florida were randomized to receive either the: 1) in-person consult, 2) parent-youth letter, 3) adolescent newsletter, or 4) standard care control . Three-month, one-year and 18-month follow-ups are planned, with interventions to be implemented in rotating fashion as re-interventions immediately after three-month and one-year data collections. Plans for following year include the following: 1) collecting and analyzing 3-month post-intervention data to determine the effects of the initial consult, parent-youth and adolescent print strategies, intervention costs, and assess possible mediators and moderators of outcomes; 2) implementing the first round of re-interventions; 3) collecting and analyzing one-year post-baseline effects of re-interventions, determining costs and cost-effectiveness of the interventions/re-interventions, and assessing possible mediators and moderators of outcomes; and 4) implementing the second round of re-interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Consult | Experimental | Behavioral: Brief Prevention Program Using Positive ImageConsult |
| Newsletter | Experimental | Behavioral: Brief Prevention Program Using Positive ImageNewsletter |
| Parent Letter | Experimental | Behavioral: Brief Prevention Program Using Positive ImageParent Letter |
| Control | Active comparator | Behavioral: Brief Prevention Program Using Positive ImageControl |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Can read English
- 10th and 11th grade high school students at participating sites
Key exclusion criteria (2 listed)
- Cannot read English
- Not in 10th and 11th grade high school students at participating sites
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 |
|---|---|---|
| Brief Prevention Program Using Positive ImageAlso: ConsultConsult | Behavioural | Consult |
| Brief Prevention Program Using Positive ImageAlso: ControlControl - Standard of Care | Behavioural | Control |
| Brief Prevention Program Using Positive ImageAlso: NewsletterNewsletter | Behavioural | Newsletter |
| Brief Prevention Program Using Positive ImageAlso: Parent LetterParent Letter | Behavioural | Parent Letter |
Primary outcome
Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Time frame: Baseline to 3 months follow up
Change in alcohol, cigarette and marijuana use consumption from baseline to 12 months follow up.
Time frame: Baseline to 12 months follow up
Change in alcohol, cigarette and marijuana use consumption from baseline to 18 months follow up.
Time frame: Baseline to 18 months follow up
3 secondary outcomes
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Time frame: Baseline to 3 months follow up
Change in frequency of health promoting behaviors from baseline to 12 months follow up.
Time frame: Baseline to 12 months follow up
Change in frequency of health promoting behaviors from baseline to 18 months follow up.
Time frame: Baseline to 18 months follow up
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 22 Nov 2011.
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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.
Chudley E Werch, PhD principal investigator
Addictive & Health Behaviors Research Institute, University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Prevention Program Using Positive Image in people with Alcohol Abuse and Drug Abuse, run by University of Florida 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 2 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 22 Nov 2011. 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?
Change in alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up. (time frame: Baseline to 3 months follow up). The study lists 3 primary outcomes in all. 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 22 Nov 2011.