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临床试验/NCT00310258
NCT00310258已完成3 期

Drug Abuse Prevention: A Mother-Daughter Intervention

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
2,000
试验地点
1
主要终点
Scores on substance use behavior at posttest, and annually for 3 years after posttest.

研究概览

简要总结

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.

详细描述

The study has two primary and seven secondary aims.

Primary Aims:

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

Secondary Aims:

    1. 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.
    1. Examine the effects of mediating factors on girls' substance use behavior.
    1. Test GSI to improve mothers' use of family rituals, rules against substance use, child management, mother-daughter affective quality, and communication with their daughters.
    1. Examine the effects of mother' outcomes on their daughters' substance use behavior.
    1. Test the effects of dose on participants' outcomes.
    1. Determine if GSI has differential outcomes related to ethnic-racial group profile.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 13 Years(Child)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

次要结局

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

研究者

申办方类型
Nih

研究点 (1)

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