Choices4Health: Intervention to Prevent Substance-exposed Pregnancy
Condition: Prenatal Alcohol Exposure; Prenatal Tobacco Exposure; Prenatal Marijuana Exposure
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T
      (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a
      counselor, and brief advice (BA), on reducing preconception substance-exposed pregnancy risk
      (i.e. drinking below risk levels; tobacco and marijuana cessation; effective contraception
      use) among women (aged 18-44) presenting to the 13 primary care clinics that serve adults
      within the Harris Health System. Given the natural fit between contraceptive and HIV
      prevention counseling the CHOICES4Health interventions will also target HIV sexual risk
      behaviors.
    

Detailed description: 
      A randomized group design (N = 240) will be used to test the efficacy of the C4H-C and C4H-T
      interventions relative to Brief Advice (BA) to reduce the risk of substance-exposed
      pregnancy) SEP in preconception women of childbearing age. Follow-up assessments will be
      conducted at 3, 6, and 9 months.

      Each of the substances targeted in this study (risk drinking, cigarette smoking, and
      marijuana use) is commonly used relative to other substances and is singly or jointly
      associated with risk for poor fetal outcomes. Thus, women who are not using effective
      contraception (i.e., use of effective birth-control methods during all vaginal intercourse)
      and have any one or more substance-risk behaviors in the 30 days before intake will be
      eligible for the study.

      Urn randomization will be used to stratify women on all three substance-risk behaviors to
      ensure a balanced number of women presenting with alcohol-exposed pregnancy (AEP),
      tobacco-exposed pregnancy (TEP), and marijuana-exposed pregnancy (MEP) risks across the three
      study conditions. To address risk distribution for women who present with more than one risk
      behavior the urn randomization will also be programmed to balance single risk and multiple
      risk women across the study conditions. In sum, the urn randomization will include four
      assignment criteria: AEP, TEP, MEP, and multiple risks. Finally, different numbers of women
      will be needed for each type of substance-exposed pregnancy risk in order to provide
      sufficient power for the investigator's analytic tests. For example, approximately 25% more
      women at risk of AEP are required than for TEP to attain the same power. The investigators
      will include over sampling rules and stopping rules to ensure adequate recruitment for AEP,
      TEP, and MEP.
    

Intervention name(s): Computer tablet-delivered C4H; Person-delivered C4H; Brief Advice
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered on a computer-tablet.; Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered by a counselor.; Brief advice delivered by a research associate about healthy behaviors for women including use of contraception and alcohol, tobacco, and marijuana use
Other intervention name(s): C4H-T; C4H-C; BA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prenatal alcohol exposure; marijuana; smoking cessation; computer-delivered intervention; contraception; behavioral intervention; motivational interviewing