ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy (ChoicesPlus)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01032772|
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : November 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Smoking Contraception||Behavioral: Choices Plus Behavioral: Information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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
- Risk of alcohol-exposed pregnancy [ Time Frame: 9 months ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|