Preventing alcohol-exposed pregnancies: a randomized controlled trial

Send email for updates


Effectiveness bank home page. Opens new windowResearch analysis

This entry is our analysis of a study considered particularly relevant to improving outcomes from drug or alcohol interventions in the UK. The original study was not published by Findings; click Title to order a copy. Free reprints may be available from the authors – click prepared e-mail. The summary conveys the findings and views expressed in the study. Below is a commentary from Drug and Alcohol Findings.

Links to other documents. Hover over for notes. Click to highlight passage referred to. Unfold extra text Unfold supplementary text
Copy title and link | Comment/query |

Preventing alcohol-exposed pregnancies: a randomized controlled trial.

Floyd R.L., Sobell M., Velasquez M.M. et al.
American Journal of Preventive Medicine: 2007, 32(1), p. 1–10.
Unable to obtain a copy by clicking title? Try asking the author for a reprint by adapting this prepared e-mail or by writing to Dr Floyd at rlf3@cdc.gov.

Foetal exposure to alcohol is a leading cause of birth defects and developmental disabilities. Targeting interventions at women before they become pregnant – as with Project CHOICES – could shift the focus in clinical practice from treatment of substance-exposed pregnancies to prevention of a major (and costly) public health concern.

Summary Alcohol is a leading preventable cause of birth defects and developmental disabilities in the United States (1 2). Foetal exposure to alcohol can result in a spectrum of adverse effects known as foetal alcohol spectrum disorders.

Key points icon

Key points
From summary and commentary

Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. Project CHOICES trialled a brief motivational intervention designed to encourage women to change risky drinking and/or ineffective contraception use.

The intervention had a demonstrable risk-reduction impact. At the three, six, and nine-month follow-ups, the odds of being at a reduced risk of an alcohol-exposed pregnancy were twofold greater in the intervention group than in the control group.

The findings were encouraging, indicating that women who are at risk of an alcohol-exposed pregnancy can be made aware of it and make changes to reduce their risk.

Most women reduce alcohol consumption after learning that they are pregnant, but many will drink during the early critical weeks of gestation when they are not yet aware that they are pregnant. In the United States, almost half of pregnancies are unplanned, of which about half occur in women who are using contraception ineffectively or intermittently. Enhancing effective contraceptive use in women of ‘childbearing age’ who are risky drinkers could avert many alcohol-exposed pregnancies.

The efficacy of brief interventions for reducing risky drinking has been well established in previous clinical trials (1 2 3), but few have addressed both drinking and effective contraception use in one intervention. The Project CHOICES trial examined the effectiveness of a brief motivational intervention designed to encourage women to change the target behaviours of risky drinking and ineffective contraceptive use. An earlier feasibility study found that, six months after enrolment in the intervention, 69% of women had reduced their risk of an alcohol-exposed pregnancy by reducing their drinking, using effective contraception methods, or both.

What was Project CHOICES?

The Project CHOICES intervention focused on increasing participants’ commitment to change. It consisted of four motivational interviewing counselling sessions and one contraception counselling visit (unfold Unfold supplementary text the supplementary text). Although both behaviours leading to risk for alcohol-exposed pregnancy were targeted, counsellors could emphasise the target behaviour favoured by the participant.

Typically, the contraception visit occurred between the second and third counselling sessions, giving the motivational interviewing counsellors the opportunity to discuss the visit with the participant. The intervention was delivered by 21 trained counsellors supervised by the Project CHOICES Efficacy Study Research Team, and six contraceptive care providers (physicians and family planning nurses). Reimbursement for participants’ time was offered for intervention sessions.

How was the trial conducted?

Women aged 18–44 years and currently at risk for an alcohol-exposed pregnancy, were recruited from jails, drug and alcohol treatment centres, suburban primary care practices, a hospital-based gynaecology clinic, and a Medicaid health maintenance organisation in Florida, Texas, and Virginia (United States).

Women were eligible to participate in the study if they: had no condition causing infertility (tubal ligation, hysterectomy, menopause, or other reason); were not pregnant or planning on becoming pregnant in the next nine months; had vaginal intercourse during the previous three months without using effective contraception; had been drinking in a risky way; and were available for the nine-month follow-up period.

A total of 830 women participated, and were randomly allocated to either the intervention group (416) or the control group (414). Women in the control group were given brochures on drinking and women’s health, as well as a referral guide to local resources. Almost all participants in the intervention group (98%) received at least one session of counselling, and 63% received all four sessions. On average, participants attended three counselling sessions, and approximately 70% attended a contraception consultation visit.

There were no significant differences in the sociodemographic and clinical characteristics of the intervention and control groups at baseline. Study participants had an average age of 30 years, were predominately African American (48%), had never been married (51%), and had annual incomes of under $20,000 (55%). Over half (56%) met the criteria for alcohol dependence, and both illicit drug use (greater than 90%) and tobacco smoking (greater than 70%) were highly prevalent in the population. Around a third (30%) consumed an average of eight drinks per occasion, and roughly the same proportion (33%) reported no contraception use, with the remainder using contraception inconsistently or ineffectively.

Participants were interviewed at baseline, and then (if possible) assessed again at three-, six-, and nine-month follow-ups. The analysis included 665 participants who completed the three-month follow-up interview, 604 who completed the six-month follow-up interview, and 593 who completed the nine-month follow-up interview, with approximately equal numbers in treatment and control groups at each of the phases.

The primary outcomes were: (1) risk of alcohol-exposed pregnancy; (2) risky drinking; and (3) ineffective contraception use. Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risky drinkers. Women who had intercourse without effective contraception were considered at risk of an unplanned pregnancy. Reversing either or both types of risk was deemed to result in a reduced risk of an alcohol-exposed pregnancy.

Analyses were conducted to determine the overall odds of an alcohol-exposed pregnancy – showing the risk-reduction impact of receiving the intervention versus not receiving the intervention. Analyses were also repeated to determine the odds of an alcohol-exposed pregnancy when various ‘confounding variables’ were removed (ie, factors that could have a hidden effect on the outcomes). These confounding variables were:
• number of male intercourse partners;
AUDIT questionnaire scores;
• readiness to change ineffective contraceptive use;
• processes of change for alcohol;
• the perceived pros and cons of alcohol;
• temptation to drink alcohol.

Main findings

The Project CHOICES intervention was associated with statistically significant benefits across all primary outcomes, including when confounding variables (see above) were accounted for.

At every follow-up point, the odds of being at reduced risk of an alcohol-exposed pregnancy were roughly twofold greater in the intervention group than in the control group. After removing the effects of confounding variables, these odds increased further, with women in the intervention group again significantly more likely than women in the control group to be at reduced risk of an alcohol-exposed pregnancy.

Floyd_RL_4

Significantly more women reduced their risk of an alcohol-exposed pregnancy in the intervention group than the control group at each follow-up point, but a considerable proportion of women in the control group also reduced their risk of an alcohol-exposed pregnancy.

Differences in the risk-reduction impact in the intervention group versus the control group were considerable – 18%, 17%, and 15% at the three, six, and nine-month follow-ups. However, many women in the control group also reduced their risk of an alcohol-exposed pregnancy over the course of the study (see chart).

Women who completed the study and women who did not participate in follow-up assessments were very similar. The only significant difference was that women who couldn’t be followed-up were not educated to more than a high school level.

Of the 82 participants lost to follow-up after they participated in the three-month follow-up interview, 53% in the control group and 70% in the intervention group had reduced their risk of an alcohol-exposed pregnancy. When it was assumed that all participants lost to follow-up were at risk of an alcohol-exposed pregnancy, the odds of a risk-reduction impact in the intervention group versus the control group were found to be lower but still significant at the three, six, and nine-month follow-ups, indicating that there was a benefit to being assigned to the intervention. Taken together, these findings do not suggest that the loss to follow-up caused a major bias to the study findings.

The authors’ conclusions

The featured study demonstrated that a brief behavioural motivational intervention, delivered over several sessions, could produce significant reductions in the risk of an alcohol-exposed pregnancy. Although women in both intervention and control groups reduced their risk of an alcohol-exposed pregnancy by instituting changes in the targeted risk behaviours, the odds of being at reduced risk of an alcohol-exposed pregnancy were more than double in the Project CHOICES intervention group than the control group.

Women who are not planning to become pregnant may think they have little reason to be concerned about either their drinking or contraceptive practices. Findings from this study indicate that women who are at risk of an alcohol-exposed pregnancy can be made aware of this risk, and make subsequent changes to reduce their risk.

Further research is needed to determine which components of the intervention were most effective, how a minimal intervention could remain effective in the long term, and the extent to which this intervention can prove effective in populations not included in this study.

In view of the results, and considering that brief interventions are cost effective (1 2), the Project CHOICES intervention appears to be a good candidate for large-scale implementation to reduce the risk of alcohol-exposed pregnancies in high-risk populations.


Findings logo commentary The featured study found that a motivational counselling intervention, delivered over several sessions, can reduce the risk of an alcohol-exposed pregnancy by simultaneously tackling risky drinking and ineffective use of contraception. While around half of women in the information-only control group also reduced their risk of an alcohol-exposed pregnancy, the odds of being at a reduced risk of an alcohol-exposed pregnancy were roughly twofold greater in the intervention group at each follow-up point.

Possible explanations for the reduction in risk among women in the control group include:
• A phenomenon in research known as ‘regression to the mean’, which is the tendency for unusually extreme measurements to be followed by measurements closer to the population average. In other words, women who were identified as ‘high risk’ at baseline may have become less so over time.
• The control condition itself having an impact, through women being alerted to the fact that they were ‘high risk’ during the course of giving their consent to participate and/or through receiving information indicating that they might be risking their health. Women in the control group were given brochures on drinking and women’s health, as well as a referral guide to local resources. (Is a leaflet all it takes? Unfold Unfold supplementary text the supplementary text for a brief discussion).

Floyd_RL_4b Floyd_RL_4c

Proportionately more women in the intervention group reduced their risk at nine months through addressing both their drinking and contraceptive use.

At the final follow-up there did not appear to be a big difference in the average number of binge-drinking episodes between the intervention group and control group: the number of episodes decreased from 30 at baseline to seven at the nine-month follow-up in the intervention group, versus 29 binge-drinking episodes at baseline and 10 at the nine-month follow-up in the control group. The ‘median’ number of drinks per week (or midpoint in the range of values) were quite similar too – they decreased from 36 drinks at baseline to two drinks at the nine-month follow-up in the intervention group, compared to 38 drinks at baseline and three drinks at the nine-month follow-up for the control group. However, if we examine the way that risk-reduction was distributed more differences become apparent. Proportionately more women in the control group reduced their risky drinking only, and this was relatively stable at three and nine months (35% and 34% respectively, versus 28% and 20%). But, a greater proportion of women in the intervention group reduced their risk through addressing both their drinking and contraceptive use (see chart). As the featured authors said, “women receiving the intervention were more likely to adopt changes in both targeted behaviors simultaneously, thereby maximizing the likelihood of avoiding an [alcohol-exposed pregnancy]”.

Project CHOICES focused on the period before conception, aiming to increase participants’ motivation and commitment to change risky drinking and ineffective contraception in order to prevent an alcohol-exposed pregnancy from occurring in the first place. Also analysed in the Effectiveness Bank is CHOICES Plus, which offered a bundle of services in primary care settings, addressing drinking and ineffective contraception plus smoking, in half the number of sessions. After nine months, women assigned to the intervention had a significantly lower risk of alcohol- and tobacco-exposed pregnancies than women assigned to brief advice.

With evidence across a range of settings that CHOICES can significantly reduce the risk of alcohol-exposed pregnancies, the original programme has already been embraced in the US, and implemented with funding from the Substance Abuse and Mental Health Services Administration and the Centers for Disease Control and Prevention.

Last revised 18 September 2020. First uploaded 07 September 2020

Comment/query
Give us your feedback on the site (two-minute survey)
Open Effectiveness Bank home page
Add your name to the mailing list to be alerted to new studies and other site updates


Top 10 most closely related documents on this site. For more try a subject or free text search

STUDY 2017 Preventing alcohol and tobacco exposed pregnancies: CHOICES Plus in primary care

STUDY 2019 The conversation matters: a qualitative study exploring the implementation of alcohol screening and brief interventions in antenatal care in Scotland

REVIEW 2019 Fetal alcohol spectrum disorder: a systematic review of the cost of and savings from prevention in the United States and Canada

STUDY 2014 The effectiveness of alcohol screening and brief intervention in emergency departments: a multicentre pragmatic cluster randomized controlled trial

STUDY 2015 Computer-delivered screening and brief intervention for alcohol use in pregnancy: a pilot randomized trial

REVIEW 2014 Alcohol interventions, alcohol policy and intimate partner violence: a systematic review

STUDY 2013 Effectiveness of screening and brief alcohol intervention in primary care (SIPS trial): pragmatic cluster randomised controlled trial

STUDY 2016 Improving the delivery of brief interventions for heavy drinking in primary health care: outcome results of the Optimizing Delivery of Health Care Intervention (ODHIN) five-country cluster randomized factorial trial

STUDY 2012 Alcohol screening and brief intervention in primary health care

REVIEW 2010 Alcohol-use disorders: Preventing the development of hazardous and harmful drinking