Alcohol AbusePhase 1NCT01643044
Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
A Phase 1 study testing Computer-delivered, brief intervention on alcohol use in people with Alcohol Abuse, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Computer-delivered, brief intervention on alcohol use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years of age or older
- intention to carry pregnancy to term
- self-reported alcohol use
- willingness to be sent tailored messages
- gives consent to access medical records for collection of birth outcome data
Who cannot join
- unable to communicate in English
- less than 4 months before delivery due date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial
The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include:
- Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women.
- Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women.
- Evaluation of the efficacy of a computer-delivered brief intervention and use of tailored handouts to supplement the computer-based brief intervention focusing on alcohol use during pregnancy.
Read the detailed description
Infants born to African-American and/or low SES women appear to be at increased risk of adverse effects due to prenatal exposure to alcohol. Computer-delivered SBIRT approaches may provide consistent screening and evidence-based brief interventions, at low cost, without requiring substantial investments of time or energy from medical staff. However, several Stage I steps are necessary before moving to a Stage II clinical trial. This R34 application will therefore lay the groundwork for a fully powered clinical trial of a computer-delivered SBIRT for alcohol use during pregnancy. It will do so through the conduct of five key preliminary studies, including: (1) evaluation of the utility of handheld mobile devices and an anonymous self-interview format in screening for at-risk drinking among patients attending a prenatal clinic; (2) modification of an existing computer-delivered motivational intervention for alcohol use during pregnancy, to previously set standards of acceptability (to experts as well as representative pregnant women); (3) development of an evidence-based tailored messaging supplement to the single-session brief intervention; (4) examining the validity of, and cut scores for, the biomarker Ethyl Glucoronide (EtG) in pregnant women; and (5) collecting data on the acceptability, feasibility, and estimated effect size of the modified computer-delivered intervention through an N = 50 Phase I randomized clinical trial. Participants in this trial will be a diverse sample of women at-risk for alcohol use during pregnancy, the majority of whom will be African-American and/or low SES. These key preparatory steps will greatly facilitate the subsequent development of an R01 application to conduct a Stage II clinical trial for alcohol use during pregnancy. These steps will also provide important preliminary data on (a) a novel method for risk factor screening in primary care; (b) the potential utility of EtG as a biomarker for alcohol use during pregnancy and in the perinatal period; and (c) the effect size estimate for a fully computer-delivered, combined brief interactive/tailored messaging intervention requiring only a single contact. If successful, this line of research could lead to a highly cost-effective, high-reach intervention for alcohol use during pregnancy; these reductions in alcohol use could in turn have a meaningful population impact on Fetal Alcohol Spectrum Disorders.
- Conditions
- Alcohol Abuse
- Being tested
- Nutrition time control/placebo intervention, Computer-delivered, brief intervention on alcohol use
- Keywords
- pregnancy, screening, motivation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition time control/placebo interventionBehavioural
This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.
Computer-delivered, brief intervention on alcohol useBehavioural
A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol intervention | Experimental | Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal. Receives: Behavioral: Computer-delivered, brief intervention on alcohol use |
| Control | Placebo comparator | Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition. Receives: Behavioral: Nutrition time control/placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use
Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.
Measured: self-reported use during 90 days prior to delivery of their baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startApr 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol AbuseStudies 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 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Steven J. Ondersma, Wayne State University
- Investigators
- Steven J Ondersma, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643044
- Sponsor's protocol ID
- R34AA020056
- Other IDs
- R34AA020056
- Status last verified
- Jul 2014
- First submitted
- 13 Jul 2012
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial
- ClinicalTrials.gov ID
- NCT01643044
- Acronym / sponsor ID
- R34AA020056
- Conditions
- Alcohol Abuse
- Keywords
- pregnancy, screening, motivation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Posted 1 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include:
- Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women.
- Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women.
- Evaluation of the efficacy of a computer-delivered brief intervention and use of tailored handouts to supplement the computer-based brief intervention focusing on alcohol use during pregnancy.
Detailed description
Infants born to African-American and/or low SES women appear to be at increased risk of adverse effects due to prenatal exposure to alcohol. Computer-delivered SBIRT approaches may provide consistent screening and evidence-based brief interventions, at low cost, without requiring substantial investments of time or energy from medical staff. However, several Stage I steps are necessary before moving to a Stage II clinical trial. This R34 application will therefore lay the groundwork for a fully powered clinical trial of a computer-delivered SBIRT for alcohol use during pregnancy. It will do so through the conduct of five key preliminary studies, including: (1) evaluation of the utility of handheld mobile devices and an anonymous self-interview format in screening for at-risk drinking among patients attending a prenatal clinic; (2) modification of an existing computer-delivered motivational intervention for alcohol use during pregnancy, to previously set standards of acceptability (to experts as well as representative pregnant women); (3) development of an evidence-based tailored messaging supplement to the single-session brief intervention; (4) examining the validity of, and cut scores for, the biomarker Ethyl Glucoronide (EtG) in pregnant women; and (5) collecting data on the acceptability, feasibility, and estimated effect size of the modified computer-delivered intervention through an N = 50 Phase I randomized clinical trial. Participants in this trial will be a diverse sample of women at-risk for alcohol use during pregnancy, the majority of whom will be African-American and/or low SES. These key preparatory steps will greatly facilitate the subsequent development of an R01 application to conduct a Stage II clinical trial for alcohol use during pregnancy. These steps will also provide important preliminary data on (a) a novel method for risk factor screening in primary care; (b) the potential utility of EtG as a biomarker for alcohol use during pregnancy and in the perinatal period; and (c) the effect size estimate for a fully computer-delivered, combined brief interactive/tailored messaging intervention requiring only a single contact. If successful, this line of research could lead to a highly cost-effective, high-reach intervention for alcohol use during pregnancy; these reductions in alcohol use could in turn have a meaningful population impact on Fetal Alcohol Spectrum Disorders.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol intervention | Experimental | Behavioral: Computer-delivered, brief intervention on alcohol useParticipants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal. |
| Control | Placebo comparator | Behavioral: Nutrition time control/placebo interventionParticipants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- intention to carry pregnancy to term
- self-reported alcohol use
- willingness to be sent tailored messages
- gives consent to access medical records for collection of birth outcome data
Key exclusion criteria (2 listed)
- unable to communicate in English
- less than 4 months before delivery due date
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 |
|---|---|---|
| Nutrition time control/placebo interventionThis time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos. | Behavioural | Control |
| Computer-delivered, brief intervention on alcohol useA single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant. | Behavioural | Alcohol intervention |
Primary outcome
Alcohol Use
Time frame: self-reported use during 90 days prior to delivery of their baby
Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven J Ondersma, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer-delivered, brief intervention on alcohol use in people with Alcohol Abuse, run by Wayne State University 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 5 inclusion and 2 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 1 Aug 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Use (time frame: self-reported use during 90 days prior to delivery of their baby). 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 1 Aug 2014.