Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial

Completed · Not applicable

Conditions studied: Fetal Alcohol Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT02128880

Run by

University of Virginia

People needed

74

Starts

2015-02-01

Expected to finish

2016-08-01

Last updated by the study team

2016-10-26

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women ages 18-44 who are fertile
• can provide informed consent
• are at risk for unintended pregnancy due to ineffective, inconsistent, or absent contraception in the past 3 months
• speak and read English
• have more than 1 episode of drinking 4 or more standard drinks/day during the past 3 months
• have regular access to a computer, the Internet, and telephone
• reside in the US.

You may not qualify if…

• • Currently pregnant or planning pregnancy in the next 6 months
• cognitive disorders including mental retardation and dementia that could impair ability to understand the intervention material or give informed consent, or psychotic disorder due to the same issues
• live outside the US

Where it is running

• Behavioral Health and Technology Lab — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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