Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | December 2015 |
| Contact: | Karen S Ingersoll, Ph.D. |
| Email: | kareningersoll@virginia.edu |
| Phone: | 434-982-5960 |
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.
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.
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.
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.
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
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