- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01236248
Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention
July 14, 2017 updated by: Columbia University
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.
Study Overview
Detailed Description
This study longitudinally tested a computerized, parent-involvement substance abuse prevention program for adolescent girls and their mothers.
The prevention program aimed to strengthen and sustain the mother-daughter bond while equipping girls with the necessary information and skills to increase protective factors and reduce risk factors associated with tobacco, alcohol, and other harmful substance use.
Study Type
Interventional
Enrollment (Actual)
916
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Columbia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 13 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- English-speaking New York City (NYC) area girls
- Ages 11 - 13 years
- Must have private access to a computer with high-speed connectivity
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Prevention Program
Girls and their mothers who are assigned to participate in a tobacco, alcohol, and other drug use prevention program aimed at young girls.
|
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.
|
|
NO_INTERVENTION: No Prevention Program
Girls and their mothers who are assigned to participate in questionnaires only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Substance Use
Time Frame: Annually
|
Measured 30-day alcohol, tobacco, and other illicit drug use among girls.
|
Annually
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven P Schinke, PhD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
October 4, 2012
Study Registration Dates
First Submitted
November 5, 2010
First Submitted That Met QC Criteria
November 5, 2010
First Posted (ESTIMATE)
November 7, 2010
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2017
Last Update Submitted That Met QC Criteria
July 14, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAB2130
- R01DA017721 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.