Choices4Health: Intervention to Prevent Substance-exposed Pregnancy

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 oversampling rules and stopping rules to ensure adequate recruitment for AEP,
TEP, and MEP.

Inclusion Criteria: Women who:

- are 18-44 years old;

- have no condition causing infertility (e.g., tubal ligation, hysterectomy, menopause);

- are not pregnant or planning to become pregnant in the next 12 months;

- are available for the follow-up period;

- had vaginal intercourse during the previous 30 days with a fertile man and did not use
effective contraception every time AND are drinking at risk levels (more than 3
drinks/day or more than 7 drinks/week); OR are reporting marijuana use in the previous
month, OR are currently smoking cigarettes (at least weekly use) during the 30-day
baseline period.

Exclusion Criteria: Women who:

- have severe cognitive, and/or psychiatric impairment that precludes cooperation with
study protocol, per judgment of the C4H interventionist or research staff;

- are unable to read, write, and speak English or Spanish;

- are unable or unwilling to meet study requirements, including followup assessments.