Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial (CARRII)

October 24, 2016 updated by: Karen Ingersoll, University of Virginia

A Randomized Clinical Trial of the Contraception and Alcohol Risk Reduction Internet Intervention to Reduce AEP Risk in Community Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As the first study of a fully interactive Internet intervention for reducing AEP risk, the proposed project is a significant extension of the growing literature on Internet interventions to reduce problem drinking, which established their feasibility and acceptability, with evidence of efficacy especially in the university drinking setting. Most brief online interventions for problem drinking have incorporated self-assessment and tailored normative feedback, and some offer cognitive behavioral exercises. Only one web-based intervention to date targeted AEP risk. In that study, a static Internet presentation of AEP risk reduction intervention materials was compared to the same intervention delivered by mail in a quasi-experimental design. The web delivered and mailed versions of this self-guided change intervention significantly reduced AEP risk. The proposed intervention will build on this study as well as existing alcohol Internet intervention findings and extend the focus to a new population with a new goal (AEP prevention) by targeting both drinking AND ineffective contraception. It will also incorporate significant enhancements compared to the static web-based self-guided change intervention for AEP by adding dynamic, interactive, and feedback elements that mirror the interaction in successful face-to-face interventions.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Behavioral Health and Technology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CARRII
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.
Behavioral: CARRII
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 Names:
  • Patient Ed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks per drinking day (DDD)
Time Frame: 90 day
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.
90 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ineffective contraception rate
Time Frame: 90 day
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.
90 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol-exposed pregnancy risk
Time Frame: 90-day
This variable is determined by the combination of drinking risk and pregnancy risk.
90-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Karen S Ingersoll, Ph.D., University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17319
  • R34AA020853 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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