ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

Study Overview
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Brief Summary
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Choices Plus, a randomized controlled study, will determine the efficacy of the Project CHOICES intervention plus a referral to an evidence-based smoking cessation program in reducing the risk of alcohol- and tobacco-exposed pregnancies.

Detailed Description
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This randomized controlled study will examine the effect of the ChoicesPlus intervention compared to Treatment as Usual (TAU) in: reducing alcohol use below established risk levels; increasing consistent use of effective contraception; increasing engagement in smoking cessation treatment and increasing smoking cessation. In addition, our examination of the incremental costs of the ChoicesPlus intervention (e.g., staff time, materials, administrative services, total medical charges pre- and post-intervention) will provide a basis for future cost/benefit analyses that will inform policymakers and healthcare organizations of the potential benefits of implementing ChoicesPlus. Results from this study will inform and advance future efforts in the service of promoting healthy prenatal behavior and reducing the prevalence of alcohol and tobacco-exposed pregnancies.

Official Title
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ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy

Conditions
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Alcohol Use, Smoking, Contraception

Intervention / Treatment
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* Behavioral: Choices Plus
* Behavioral: Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have no condition causing infertility Are not pregnant or planning to become pregnant in the next 9 months Have had vaginal intercourse during the previous 3 months with a fertile man without using effective contraception Are drinking at risk levels; and 5) are available for the follow-up period. Exclusion Criteria: Infertile Pregnant Insufficient locator information Language other than English or Spanish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHOICES Plus Intervention<br>A two session intervention utilizing a motivational interviewing approach to encourage changes in alcohol use, contraceptive use, and smoking. The interventions will (a) provide norms-based-but personalized-feedback, (b) encourage attendance at a contraceptive counseling visit, (c) encourage participation in the smoking cessation program, (c) increase motivation to change each of the target behaviors, (d) decrease temptation to engage in risk behaviors, (e) increase confidence to avoid risk behaviors, and (f) develop a personalized, tailored change plan. | Behavioral: Choices Plus<br>* Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.<br>|
| Active Comparator: Information<br>Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals. | Behavioral: Information<br>* Participants are provided with informational materials about healthy lifestyle and local resources.<br>* Other names: Treatment As Usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of alcohol-exposed pregnancy | Timeline Followback | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marin Acculturation Scale, AUDIT, Time-Line Follow Back, University of Rhode Island Change Assessment Scale, Decisional Balance, Process of Change, Temptation, Confidence, Smoking Staging Algorithm, and Brief Symptom Inventory-18 |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy