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NCT02128880 · ClinicalTrials.gov registry record · NA
Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial
A NA study of Fetal Alcohol Spectrum Disorders, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT02128880: Completed NA study of Fetal Alcohol Spectrum Disorders, sponsored by University of Virginia.
NCT02128880 is a NA study of Fetal Alcohol Spectrum Disorders that has completed, run by University of Virginia. The registered enrollment target is 74 participants, below the 99-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02128880, a NA study of Fetal Alcohol Spectrum Disorders, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL CARRII
- BEHAVIORAL CARRII Education
Study Locations (1)
Virginia
- Behavioral Health and Technology Lab - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-08 |
| Phase | NA |
What the finished NCT02128880 record still lists
NCT02128880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 99-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Fetal Alcohol Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which CARRII is the first listed.
NCT02128880 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT02128880 about?
NCT02128880 is a clinical study titled "Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial". 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...
What is the current status of trial NCT02128880?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2015-02. Estimated completion is 2016-08.
What conditions does trial NCT02128880 study?
This clinical trial studies the following conditions: Fetal Alcohol Spectrum Disorders.
What interventions are being tested in trial NCT02128880?
The interventions under investigation include: CARRII (BEHAVIORAL), CARRII Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT02128880?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02128880 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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