NCT01813123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
788

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

March 8, 2013

Last Update Submit

June 26, 2019

Conditions

Drug Abuse Prevention

Keywords

gender-specificweb-baseddrug abuseprevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 3 years

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

RealTeen

Behavioral: RealTeen

Interventions

RealTeenBEHAVIORAL

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).

Intervention

Eligibility Criteria

Age13 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • resident of USA
  • speaks English
  • have private computer with Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Traci M Schwinn, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 18, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2017

Study Completion

January 30, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

US(1)