Prevention Harmful EffectsProject BESTNCT01482975
Tailored Interventions to Prevent Substance Abuse
A study testing Tailored computer based intervention and Tailored computer intervention in people with Prevention Harmful Effects, run by University of Rhode Island at 1 site in United States.
Trial summary
The overarching objective of this research is to prevent substance use in early adolescents through the use of innovative interactive interventions tailored to each individual's particular risk profile for using cigarettes and alcohol. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- Tailored computer based intervention and Tailored computer intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,158 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2011
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6th grade student in one of 20 participating Middle Schools in RI
- English speaking
- Student Assent
Who cannot join
- Parent refusal for child to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
The overarching objective of this research is to prevent substance use in early adolescents through the use of innovative interactive interventions tailored to each individual's particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents from using alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet and physical activity interventions will be effective in reducing these two high risk behaviors as part of the comparison condition.
Read the detailed description
Research across age groups (elementary, middle and high school), populations (U.S., U.K., and Israel), and substances (tobacco, alcohol and other drugs) has consistently identified four clusters of non-users who vary in their risks for substance use: (1) Most Protected from substance use; (2) High Risk to use substances; (3) Ambivalent about staying substance free; and (4) Risk Denial about substance use. These profiles have demonstrated both internal and external validity as well as good ability to predict future substance use and, therefore, provide an opportunity to develop a new approach to prevention. These profiles will be employed as the basis for designing two innovative computer-based interventions to prevent substance abuse by adolescents. The two new tailored interventions (smoking prevention and alcohol prevention) will be developed and tested in a school-based clinical trial. The comparison group will receive two previously developed and tested tailored health behavior interventions (diet and physical activity).
- Conditions
- Prevention Harmful Effects
- Being tested
- Tailored computer based intervention, Tailored computer intervention
- Keywords
- tobacco, alcohol, diet, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored computer based interventionOther
Also called Tailored computer based interventions
Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment.
Tailored computer interventionOther
Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment
| Study group | Role | What they receive |
|---|---|---|
| Smoking and Alcohol Prevention | Experimental | TTM expert system Receives: Other: Tailored computer based intervention |
| Diet and Exercise | Active comparator | TTM expert system Receives: Other: Tailored computer intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Prevention
Percent reporting being smoke-free at 36 months
Measured: 36 months
Alcohol Use Prevention
Percent reporting being alcohol-free at 36 months
Measured: 36 months
Exercise
Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).
Measured: 36 months
Diet
Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startSep 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention Harmful EffectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne F. Velicer, University of Rhode Island
- Investigators
- Wayne F Velicer, PhD, Principal investigator, Univeristy of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482975
- Sponsor's protocol ID
- DA020112
- Acronym
- Project BEST
- Status last verified
- May 2016
- First submitted
- 29 Nov 2011
- Last updated
- 12 May 2016
- 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 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Interventions to Prevent Substance Abuse
- ClinicalTrials.gov ID
- NCT01482975
- Acronym / sponsor ID
- Project BEST / DA020112
- Conditions
- Prevention Harmful Effects
- Keywords
- tobacco, alcohol, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,158 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Dec 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 overarching objective of this research is to prevent substance use in early adolescents through the use of innovative interactive interventions tailored to each individual's particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents from using alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet and physical activity interventions will be effective in reducing these two high risk behaviors as part of the comparison condition.
Detailed description
Research across age groups (elementary, middle and high school), populations (U.S., U.K., and Israel), and substances (tobacco, alcohol and other drugs) has consistently identified four clusters of non-users who vary in their risks for substance use: (1) Most Protected from substance use; (2) High Risk to use substances; (3) Ambivalent about staying substance free; and (4) Risk Denial about substance use. These profiles have demonstrated both internal and external validity as well as good ability to predict future substance use and, therefore, provide an opportunity to develop a new approach to prevention. These profiles will be employed as the basis for designing two innovative computer-based interventions to prevent substance abuse by adolescents. The two new tailored interventions (smoking prevention and alcohol prevention) will be developed and tested in a school-based clinical trial. The comparison group will receive two previously developed and tested tailored health behavior interventions (diet and physical activity).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking and Alcohol Prevention | Experimental | Other: Tailored computer based interventionTTM expert system |
| Diet and Exercise | Active comparator | Other: Tailored computer interventionTTM expert system |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6th grade student in one of 20 participating Middle Schools in RI
- English speaking
- Student Assent
Key exclusion criteria (1 listed)
- Parent refusal for child to participate
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 |
|---|---|---|
| Tailored computer based interventionAlso: Tailored computer based interventionsBest practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment. | Other | Smoking and Alcohol Prevention |
| Tailored computer interventionBest practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment | Other | Diet and Exercise |
Primary outcome
Smoking Prevention
Time frame: 36 months
Percent reporting being smoke-free at 36 months
Alcohol Use Prevention
Time frame: 36 months
Percent reporting being alcohol-free at 36 months
Exercise
Time frame: 36 months
Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).
Diet
Time frame: 36 months
Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).
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 12 May 2016.
- Individual participant dataSharing planned: No
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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.
Wayne F Velicer, PhD principal investigator
Univeristy of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored computer based intervention and Tailored computer intervention in people with Prevention Harmful Effects, run by University of Rhode Island 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 3 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 12 May 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.
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?
Smoking Prevention (time frame: 36 months). The study lists 4 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 12 May 2016.