Drug Use Prevention Among Girls Through a Mother-Daughter Intervention

Adolescent Behavior Clinical Trial

Official title:

Drug Abuse Prevention: A Mother-Daughter Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310258
• Other study ID #: girls & drugs
• Secondary ID: 5R01DA017721-02
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2006
• Last updated: January 10, 2017
• Start date: April 2005
• Est. completion date: February 2006

Study information

• Verified date: March 2006
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 13 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• Drug use prevention intervention

Locations

Country	Name	City	State
United States	Columbia University School of Social Work	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on substance use behavior at posttest, and annually for 3 years after posttest.
Secondary	scores on mediating variables at posttest, and annually for 3 years after posttest.
Secondary	closeness with mother
Secondary	coping skills
Secondary	refusal skills
Secondary	depression (mood)
Secondary	conflict resolution
Secondary	problem solving
Secondary	self-efficacy
Secondary	body image
Secondary	normative beliefs