A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Primary Purpose
Drug Abuse Prevention
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RealTeen
Sponsored by
About this trial
This is an interventional prevention trial for Drug Abuse Prevention focused on measuring gender-specific, web-based, drug abuse, prevention
Eligibility Criteria
Inclusion Criteria:
- resident of USA
- speaks English
- have private computer with Internet
Exclusion Criteria:
-
Sites / Locations
- Columbia University School of Social Work
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
RealTeen
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01813123
First Posted
March 8, 2013
Last Updated
June 26, 2019
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01813123
Brief Title
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Official Title
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse Prevention
Keywords
gender-specific, web-based, drug abuse, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
788 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
RealTeen
Intervention Type
Behavioral
Intervention Name(s)
RealTeen
Intervention Description
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).
Primary Outcome Measure Information:
Title
30-day alcohol and drug use
Description
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.
Time Frame
Up to 3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
resident of USA
speaks English
have private computer with Internet
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Traci M Schwinn, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
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A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
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