Drug Use Prevention Among Girls Through a Mother-Daughter Intervention

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00310258
First received: March 30, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Adolescent Behavior
Behavioral: Drug use prevention intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Drug Abuse Prevention: A Mother-Daughter Intervention

Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Secondary Outcome Measures:
  • 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
  • self-efficacy
  • body image
  • normative beliefs

Estimated Enrollment: 2000
Study Start Date: April 2005
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   11 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310258

Locations
United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Investigators
Principal Investigator: Steven Schinke, Ph.D. Columbia University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310258     History of Changes
Other Study ID Numbers: girls & drugs, 5 R01 DA017721-02
Study First Received: March 30, 2006
Last Updated: March 30, 2006
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 19, 2014