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

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ClinicalTrials.gov Identifier: NCT02128880
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia

Tracking Information
First Submitted Date  ICMJE April 29, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02128880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 29, 2014)
Alcohol-exposed pregnancy risk [ Time Frame: 90-day ]
This variable is determined by the combination of drinking risk and pregnancy risk.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial
Official Title  ICMJE A Randomized Clinical Trial of the Contraception and Alcohol Risk Reduction Internet Intervention to Reduce AEP Risk in Community Women
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Fetal Alcohol Spectrum Disorders
Intervention  ICMJE
  • Behavioral: CARRII
    CARRII is an interactive, personalized and tailored Internet intervention designed to reduce the risk of AEP among drinking women of childbearing age.
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: CARRII
  • 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.
    Intervention: Behavioral: CARRII Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
70
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128880
Other Study ID Numbers  ICMJE 17319
R34AA020853 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karen Ingersoll, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia
PRS Account University of Virginia
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP