Drug Abuse PreventionNCT01813123
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
A study testing RealTeen in people with Drug Abuse Prevention, run by Columbia University at 1 site in United States.
Trial summary
This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Read more about this study
- Who is it for?
- Ages 13 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse Prevention
- What is being tested?
- RealTeen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 30 Jan 2019
- 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 13 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- resident of USA
- speaks English
- have private computer with Internet
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University School of Social Work
New York, New York, 10027
About this study
This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions.
The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.
- Conditions
- Drug Abuse Prevention
- Being tested
- RealTeen
- Keywords
- gender-specific, web-based, drug abuse, prevention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RealTeenBehavioural
A web-based, gender-specific program intended improve girls' cognitive and behavioral skills. Each of the 9 sessions requires approximately 20 minutes. After initial intervention, girls will receive two annual booster sessions (i.e., a 20-minute review of previously learned material indexed to new age).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | RealTeen Receives: Behavioral: RealTeen |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day alcohol and drug use
Measures will ask girls to report, for the past 30 days, the number of: drinks of alcohol consumed, cigarettes smoked, puffs of marijuana, and times they consumed four or more drinks within 2 hours. Girls will also report past 30-day use of: inhalants, ecstasy, club drugs, prescription drugs for recreational use, heroin, and hallucinogens.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2017
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Abuse PreventionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Traci M. Schwinn, Columbia University
- Investigators
- Traci M Schwinn, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813123
- Sponsor's protocol ID
- AAAJ3409
- Other IDs
- R01DA031782
- Status last verified
- Jun 2019
- First submitted
- 8 Mar 2013
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
- ClinicalTrials.gov ID
- NCT01813123
- Acronym / sponsor ID
- AAAJ3409
- Conditions
- Drug Abuse Prevention
- Keywords
- gender-specific, web-based, drug abuse, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 18 Mar 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.
This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions.
The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: RealTeenRealTeen |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- resident of USA
- speaks English
- have private computer with Internet
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 |
|---|---|---|
| RealTeenA web-based, gender-specific program intended improve girls' cognitive and behavioral skills. Each of the 9 sessions requires approximately 20 minutes. After initial intervention, girls will receive two annual booster sessions (i.e., a 20-minute review of previously learned material indexed to new age). | Behavioural | Intervention |
Primary outcome
30-day alcohol and drug use
Time frame: Up to 3 years
Measures will ask girls to report, for the past 30 days, the number of: drinks of alcohol consumed, cigarettes smoked, puffs of marijuana, and times they consumed four or more drinks within 2 hours. Girls will also report past 30-day use of: inhalants, ecstasy, club drugs, prescription drugs for recreational use, heroin, and hallucinogens.
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 27 Jun 2019.
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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.
Traci M Schwinn, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RealTeen in people with Drug Abuse Prevention, run by Columbia University 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 27 Jun 2019. 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?
30-day alcohol and drug use (time frame: Up to 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 27 Jun 2019.