NCT00310258

Brief Summary

This study will develop and test drug use prevention strategies for low-income, minority girls. Gender-specific substance use rates, risk and protective factors, and health outcomes highlight the need for interventions aimed at girls. Girls and boys share a number of risk factors, yet some factors are more salient for one gender. Girls and boys may also be affected differently by the same risk factors. Intervention planned for this study emphasizes risk and protective factors that impact girls. Our intervention will build mother-daughter communication and closeness; enhance girls' self-efficacy and body esteem; nurture girls' conflict management, problem-solving, stress reduction, and refusal skills; correct perceived norms; build social supports; and establish patterns of parental monitoring and supervision. We hypothesise that girls who receive GSI will have lower 3-year follow-up rates of substance use than girls who receive no intervention. The study will occur in three phases. In a 12-month preparation phase, we will refine and complete intervention and measurement protocols, recruit subjects and randomly assign girls and mothers to study arms, and pretest girls and mothers. A 12-month implementation phase will initiate field operations of the clinical trial, including intervention delivery, process data collection, and posttests. Follow-up in the last 36 months will involve longitudinal measurements of girls and mothers, booster session development and delivery, and data analyses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3

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

April 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

January 11, 2017

Status Verified

March 1, 2006

First QC Date

March 30, 2006

Last Update Submit

January 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scores on substance use behavior at posttest, and annually for 3 years after posttest.

Secondary Outcomes (10)

  • scores on mediating variables at posttest, and annually for 3 years after posttest.

  • closeness with mother

  • coping skills

  • refusal skills

  • depression (mood)

  • +5 more secondary outcomes

Interventions

Eligibility Criteria

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

You may qualify if:

  • girls ages 11 to 13 years old at pretest and their mothers who have access to a private computer

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

Related Publications (1)

  • Schinke S, Di Noia J, Schwinn T, Cole K. Drug abuse risk and protective factors among black urban adolescent girls: a group-randomized trial of computer-delivered mother-daughter intervention. Psychol Addict Behav. 2006 Dec;20(4):496-500. doi: 10.1037/0893-164X.20.4.496.

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Steven Schinke, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

March 30, 2006

First Posted

April 3, 2006

Study Start

April 1, 2005

Study Completion

February 1, 2006

Last Updated

January 11, 2017

Record last verified: 2006-03

Locations