NCT01236248

Brief Summary

The purpose of this study is to determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
916

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2012

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

5.2 years

First QC Date

November 5, 2010

Last Update Submit

July 14, 2017

Conditions

Substance Use

Keywords

drugsyouthparentcomputerprevention

Outcome Measures

Primary Outcomes (1)

  • Rate of Substance Use

    Measured 30-day alcohol, tobacco, and other illicit drug use among girls.

    Annually

Study Arms (2)

Prevention Program

EXPERIMENTAL

Girls and their mothers who are assigned to participate in a tobacco, alcohol, and other drug use prevention program aimed at young girls.

Behavioral: Prevention

No Prevention Program

NO INTERVENTION

Girls and their mothers who are assigned to participate in questionnaires only.

Interventions

PreventionBEHAVIORAL

9-session computerized cognitive behavioral program that young girls and their mothers interact with on a weekly basis in the privacy of their home. Girls and their mothers will watch and interact with 10 compact disc (CD) intervention sessions to learn skills to help girls avoid substance use.

Prevention Program

Eligibility Criteria

Age11 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • English-speaking New York City (NYC) area girls
  • Ages 11 - 13 years
  • Must have private access to a computer with high-speed connectivity

You may not qualify if:

  • Non-English-speaking girls who do not live in the NYC area
  • Younger than 11 or older than 13 years of age
  • Those who lack of private access to a computer with high-speed connectivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Steven P Schinke, 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
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 8, 2010

Study Start

December 1, 2004

Primary Completion

March 1, 2010

Study Completion

October 4, 2012

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

US(1)