In 1997, the Centers for Disease Control and Prevention (CDC) began to pursue primary prevention of prenatal alcohol exposure by focusing on women at high risk for an AEP before conception. A year later, three university sites were funded to conduct a collaborative study to develop and test promising approaches for achieving this objective. Each university proposed two community-based settings with higher proportions of at-risk women than could be expected in the general population. In Florida (Fort Lauderdale), the two sites included a primary care practice in a large suburban hospital catchment area and media recruitment. In Texas, the sites included a large urban jail and three drug treatment agencies in the greater Houston area. In Virginia (Richmond), the two sites included a university-hospital obstetrical/gynecology practice and a community primary care center. To confirm that the settings had a high proportion of at-risk women, investigators from the three sites and the CDC first conducted an epidemiological survey during 1998–2000. Rates of women at risk for an AEP based on both reported alcohol consumption and contraceptive practices varied across the six settings, with higher rates in the jail (21%) and alcohol and drug treatment centers (24%), and lower rates in primary care settings (5%). The risk of AEP in the combined settings (N
= 2,672) was 13.0%, in contrast to the overall national average of 2% among fertile women, confirming that the selected study settings were appropriate locations to implement interventions targeted at reducing AEP (Project CHOICES Research Group, 2002
After conducting a successful single-arm multisite study to determine the feasibility and promise of the CHOICES intervention (Project CHOICES Intervention Research Group, 2003
), the intervention was tested in a randomized controlled trial (RCT). Results were recently reported (Floyd et al., 2007
), and are summarized here to provide context.
Recruitment strategies included the use of flyers and presentations in the settings, and newspaper and radio announcements in the community. Women who drank alcohol and were of childbearing age were invited to be screened. Of 4,626 women screened, 3,591 (77.6%) did not meet the inclusion criteria for drinking or ineffective use of contraception, and 205 of the eligible women (19.8%) refused to participate. In the RCT, 830 women were randomized to either the motivational counseling (information plus counseling; IPC) group (n = 416) or the information only (IO) group (n=414). Women in the IPC condition received the four CHOICES motivational counseling sessions and one contraception planning visit, described in detail in this paper. Women in the IO condition received one brief advice session in which they were provided with brochures on alcohol use and women’s health in general, and a referral guide to local resources. The IO session lasted, on average, from 5 to 10 minutes.
To be eligible for the study, women must have been of childbearing age (18 to 44), fertile (no tubal ligation, menopause, or other reason for infertility); had sexual intercourse with a fertile man in the past 3 months; used ineffective or no contraception; not pregnant or planning a pregnancy in the next 9 months; and reported drinking more than seven standard drinks a week on average or having more than one binge-drinking episode (≥5 standard drinks in a single day) in the past 90 days. (This definition of binge drinking was used by the CDC at the time of the study; Centers for Disease Control and Prevention, 2002
.) In addition, a woman must have stated that she would remain available for the follow-up period. Thus, at baseline all participants were at risk for an alcohol-exposed pregnancy.
Nearly all of the women in the IPC intervention condition (98%) attended at least one counseling session and 63% attended all four sessions, a higher rate than is found in most alcohol treatment studies (Wickizer et al., 1994
). The contraception consultation was attended by 70% of the women. Overall 71% of the women completed the 9-month follow-up (). Frequent phone and mail contacts and updating locator information at each counseling session and at each assessment interview contributed to the high treatment and research compliance.
Recruitment and Session Attendance
The women were 30 years of age, on average, 48% were African American, 51% had never been married, 55% had annual incomes of less than $20,000, 90% had used illicit drugs, and 70% smoked. There were no baseline differences found between the intervention women and the control women.
The primary outcome for the study was risk of an AEP, computed from data collected using the Timeline Follow-Back (TLFB) calendar method (Sobell & Sobell, 1992
) modified to assess daily vaginal intercourse and contraception behavior in addition to drinking from 90 days prior to intake to 9 months post-intake. The primary outcome was a dichotomous measure of a woman’s risk for an AEP: at-risk for an AEP or at-reduced-risk for an AEP. To reach reduced risk of AEP, women had to have been abstinent from sexual intercourse or used effective contraception every time they engaged in sexual intercourse, or drank below risk levels (no more than four drinks in a single day and no more than seven drinks in a week), or adopted changes in both behaviors.
Sixty-nine percent of the intervention women were at reduced risk of an AEP at 9 months postintervention. The intervention group was more likely to have reduced their risk of AEP (p =.05), with approximately twofold greater odds than in the control group at 9 months (OR=1.90; 95% CI=1.36–2.66) postintervention. Of the three routes to reduced risk of AEP (i.e., reduced drinking, using effective contraception, or both), most of the women chose to use effective contraception. Nearly half of the women (47.3%) had both reduced their drinking and were using effective contraception at 9 months. Routes to reduced risk of AEP for both the intervention and the control group at the 3-, 6-, and 9-month assessment time points are provided in . No differences were found in testing for effects on AEP of the diverse settings; therefore, data were combined for the longitudinal outcome analyses.
Proportion of Participants Meeting Risk Reduction Thresholds at 3, 6, and 9 Months
A simple thematic coding process was used to qualitatively analyze data from an open-ended question about which aspects of CHOICES the women found “most important.” The most frequent responses were that therapists “have a caring attitude” and were “compassionate” and “encouraging.”