Drug Use Prevention Among Girls Through a Mother-Daughter Intervention

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

Drug Abuse Prevention: A Mother-Daughter Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has two primary and seven secondary aims.

Primary Aims:

  • 1. Develop a family-based girl-specific intervention (GSI) to prevent substance use.
  • 2. Test the efficacy of GSI.

Secondary Aims:

  • 3. Test GSI to improve mediating factors of girls' mother-daughter affective quality, coping, refusal skills, mood management, conflict resolution, problem solving, self-efficacy, body esteem, normative beliefs, social supports, and mother-daughter communication.
  • 4. Examine the effects of mediating factors on girls' substance use behavior.
  • 5. Test GSI to improve mothers' use of family rituals, rules against substance use, child management, mother-daughter affective quality, and communication with their daughters.
  • 6. Examine the effects of mother' outcomes on their daughters' substance use behavior.
  • 7. Test the effects of dose on participants' outcomes.

  • 8. Determine if GSI has differential outcomes related to ethnic-racial group profile.

    9. Quantify the costs of intervention development and delivery.

Study Type

Interventional

Enrollment

2000

Phase

  • Phase 3

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

  • United States
    • New York
      • New York, New York, United States, 10027
        • Columbia University School of Social Work

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:

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

Exclusion Criteria:

-

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
self-efficacy
scores on mediating variables at posttest, and annually for 3 years after posttest.
closeness with mother
coping skills
refusal skills
depression (mood)
conflict resolution
problem solving
body image
normative beliefs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Steven Schinke, Ph.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2005

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

March 30, 2006

First Submitted That Met QC Criteria

March 30, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

March 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • girls & drugs
  • 5R01DA017721-02 (U.S. NIH Grant/Contract)

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.

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