Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial (CARRII)
The goal of the proposed research is to develop and pilot test a novel Internet intervention to reduce the risk of Alcohol-exposed pregnancy (AEP). Efficacious interventions to reduce the risk of AEP have been developed, but are not widely available. In this project, we will develop a novel Internet intervention to reduce AEP risk by combining the resources of two research teams focused on primary prevention of Fetal Alcohol Spectrum Disorders (FASD) and robust Internet interventions, respectively. We will use our evidence-based AEP risk reduction intervention materials and our existing Internet intervention development platform to build and pilot test an Internet intervention (Contraception and Alcohol Risk Reduction Internet Intervention, CARRIII) in a stage 1 behavioral and integrative therapies development project.
This three year R34 project will develop and program the new Internet intervention, and will determine the feasibility and preliminary efficacy of the intervention in a pilot RCT. In this protocol, we will assess the feasibility and preliminary efficacy of CARRIII against a Patient Education Website condition in a pilot randomized clinical trial (RCT) with assessments at pre-, post-, and 6 months.The primary hypothesis is that women randomized to the CARRIII condition will change more in 3 markers of AEP-related outcomes (risky drinking, ineffective contraception, and AEP risk) than women assigned to the Patient Education website condition. We will prepare for a future cost effectiveness evaluation in the larger RCT to follow by pilot testing proposed measures. The pilot RCT will yield effect size estimates for a subsequent fully powered trial. If the Internet intervention is promising, it should be tested in a fully powered national trial. The Internet intervention could substantially increase the options for AEP prevention, and could lead to a reduction in incident FASD.
Fetal Alcohol Spectrum Disorders
Behavioral: CARRII Education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Randomized Clinical Trial of the Contraception and Alcohol Risk Reduction Internet Intervention to Reduce AEP Risk in Community Women|
- Drinks per drinking day (DDD) [ Time Frame: 90 day ] [ Designated as safety issue: No ]The primary outcome will be drinks per drinking day measured by the combination of prospective self-report diaries and the Time-Line Follow-Back (TLFB) 90 day retrospective self-report, with a secondary outcome of episodes of ineffective contraception.
- Ineffective contraception rate [ Time Frame: 90 day ] [ Designated as safety issue: No ]The primary outcome will be drinks per drinking day measured by the combination of prospective self-report diaries and the Time-Line Follow-Back (TLFB) 90 day retrospective self-report, with a secondary outcome of episodes of ineffective contraception.
- Alcohol-exposed pregnancy risk [ Time Frame: 90-day ] [ Designated as safety issue: No ]This variable is determined by the combination of drinking risk and pregnancy risk.
|Study Start Date:||February 2015|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
CARRII: This is a highly interactive Internet intervention consisting of 6 Cores of Intervention material, including Core 1, Overview, Core 2: Your Risk for AEP, Core 3: Drinking, Core 4: Contraception, Core 5: Thoughts and Decisions, and Core 6: Commit to It.
CARRII is an interactive, personalized and tailored Internet intervention designed to reduce the risk of AEP among drinking women of childbearing age.
Active Comparator: Patient Education
CARRII Education: This is a static website containing educational information on the following topics: What is Alcohol Exposed Pregnancy (AEP)?, Fetal Alcohol Spectrum Disorders, Impact of AEP, Prevalence of AEP, Causes and Prevention of AEP, Treatment for AEP, and Links to related information.
Behavioral: CARRII Education
CARRII Education provides information on women's health related to drinking and contraception in a static website format.
Other Name: Patient Ed
Please refer to this study by its ClinicalTrials.gov identifier: NCT02128880
|Contact: Karen S Ingersoll, Ph.D.||firstname.lastname@example.org|
|Contact: Kirsten MacDonnell||434-982-5947||KEM6E@hscmail.mcc.virginia.edu|
|United States, Virginia|
|Behavioral Health and Technology Lab||Recruiting|
|Charlottesville, Virginia, United States, 22903|
|Contact: Karen S Ingersoll, Ph.D. 804-651-6929 Kareningersoll@virginia.edu|
|Contact: Kirsten MacDonnell 434-982-5947 KEM6E@hscmail.mcc.virginia.edu|
|Sub-Investigator: Lee M Ritterband, Ph.D.|
|Principal Investigator:||Karen S Ingersoll, Ph.D.||University of Virginia|