ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
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.
Behavioral: Choices Plus
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy|
- Risk of alcohol-exposed pregnancy [ Time Frame: 9 months ] [ Designated as safety issue: No ]Timeline Followback
- 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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: CHOICES Plus Intervention
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
Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
Active Comparator: Information
Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.
Participants are provided with informational materials about healthy lifestyle and local resources.
Other Name: Treatment As Usual
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032772
|United States, Texas|
|Settegast Health Center|
|Houston, Texas, United States, 77028|
|Strawberry Health Center|
|Pasadena, Texas, United States, 77506|
|Principal Investigator:||Mary M Velasquez, Ph.D.||University of Texas at Austin|
|Principal Investigator:||Kirk von Sternberg, Ph.D.||University of Texas at Austin|