Fetal Alcohol Spectrum DisordersCARRIINCT02128880
Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial
A study testing CARRII and CARRII Education in people with Fetal Alcohol Spectrum Disorders, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- CARRII and CARRII Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health and Technology Lab
Charlottesville, Virginia, 22903
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- CARRII, CARRII Education
- Keywords
- AEP, drinking, contraception, FASD, Internet interventions
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARRIIBehavioural
CARRII is an interactive, personalized and tailored Internet intervention designed to reduce the risk of AEP among drinking women of childbearing age.
CARRII EducationBehavioural
Also called Patient Ed
CARRII Education provides information on women's health related to drinking and contraception in a static website format.
| Study group | Role | What they receive |
|---|---|---|
| CARRII | Experimental | 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. Receives: Behavioral: CARRII |
| Patient Education | Active comparator | 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. Receives: Behavioral: CARRII Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks per drinking day (DDD)
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.
Measured: 90 day
Secondary outcomes (1)
Ineffective contraception rate
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.
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Karen Ingersoll, University of Virginia
- Investigators
- Karen S Ingersoll, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128880
- Sponsor's protocol ID
- 17319
- Other IDs
- R34AA020853
- Acronym
- CARRII
- Status last verified
- Oct 2016
- First submitted
- 29 Apr 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of the Contraception and Alcohol Risk Reduction Internet Intervention to Reduce AEP Risk in Community Women
- ClinicalTrials.gov ID
- NCT02128880
- Acronym / sponsor ID
- CARRII / 17319
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- AEP, drinking, contraception, FASD, Internet interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARRII | Experimental | Behavioral: CARRIICARRII: 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. |
| Patient Education | Active comparator | Behavioral: CARRII EducationCARRII 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women ages 18-44 who are fertile
Key exclusion criteria (3 listed)
- • Currently pregnant or planning pregnancy in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARRIICARRII is an interactive, personalized and tailored Internet intervention designed to reduce the risk of AEP among drinking women of childbearing age. | Behavioural | CARRII |
| CARRII EducationAlso: Patient EdCARRII Education provides information on women's health related to drinking and contraception in a static website format. | Behavioural | Patient Education |
Primary outcome
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.
1 secondary outcome
Ineffective contraception rate
Time frame: 90 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Behavioral Health and Technology Lab at University of VirginiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen S Ingersoll, Ph.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARRII and CARRII Education in people with Fetal Alcohol Spectrum Disorders, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks per drinking day (DDD) (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.