Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia
ClinicalTrials.gov Identifier:
NCT02128880
First received: April 29, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Fetal Alcohol Spectrum Disorders
Behavioral: CARRII
Behavioral: CARRII Education

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 70
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Patient Ed

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128880

Contacts
Contact: Karen S Ingersoll, Ph.D. 434-982-5960 kareningersoll@virginia.edu
Contact: Christina Frederick 434-982-5947 ccf7u@Virginia.EDU

Locations
United States, Virginia
Behavioral Health and Technology Lab Not yet recruiting
Charlottesville, Virginia, United States, 22903
Contact: Karen S Ingersoll, Ph.D.    804-651-6929    Kareningersoll@virginia.edu   
Contact: Christina Frederick    434-982-5947    ccf7u@Virginia.EDU   
Sub-Investigator: Lee M Ritterband, Ph.D.         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Karen Ingersoll, Associate Professor, Department of Psychiatry and NB Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT02128880     History of Changes
Other Study ID Numbers: 17319, R34AA020853
Study First Received: April 29, 2014
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
AEP, drinking, contraception, FASD, Internet interventions

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Fetal Diseases
Pregnancy Complications
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 25, 2014