Foetal Exposure During PregnancyNCT02337361

Computerized Tool for Preventing Prenatal Drinking

A study testing Electronic SBI in people with Foetal Exposure During Pregnancy, run by Public Health Institute, California at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. 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: Foetal Exposure During Pregnancy
What is being tested?: Electronic SBI
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 2 sitesUnited States
Study dates: 22 Feb 2016to 31 Aug 2018
Phase: Interventional
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 44 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,

Who cannot join

not fluent in english or spanish,

Trial locations and contacts

2 sites in 1 country.

United States2 sites

La Clinica Women Infants and Children Program Site
Oakland, California, 94601
Sonoma County Department of Health Services
Santa Rosa, California, 95403

Other trials in United States

About this study

Official title: Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial

Read the detailed description

This study evaluates a recently piloted, self-administered, computerized tool for reducing prenatal drinking that added novel components of drink size assessment and drink size feedback to traditional screening and brief intervention (SBI). The bilingual (English and Spanish) electronic SBI or "e-SBI" will be adapted for use with non-pregnant women and a small trial of its efficacy will be conducted in two public health clinics. The effects of drink size assessment by itself and of depression as a modifier of e-SBI efficacy will also be studied. Study findings will help design a larger trial of e-SBI's efficacy for reducing prenatal alcohol use.

An experimental design will be used for the proposed small trial. Two hundred women, who have not been pregnant in the past year and report alcohol at risky levels will be randomly assigned to e-SBI or usual care. Participants will complete baseline, 3-month and 6-month follow-up assessments. These assessments will examine drinking and pregnancy as well as possible negative outcomes, such as increased drug use associated with the e-SBI. To address methodological limitations in prior research, the study design incorporates drink size assessment to better measure drinking outcomes, minimizes assessment reactivity for controls at baseline, and includes a booster e-SBI at the 3-month follow up. This allows for the examination of whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI. With these design innovations, the study is expected to provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohol use, our proposed study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.

Conditions: Foetal Exposure During Pregnancy
Being tested: Electronic SBI
Keywords: risky alcohol use, pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electronic SBIBehavioural
Bilingual (English and Spanish) e-SBI with four key components:
1. Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.

Study groups in NCT02337361
Study group	Role	What they receive
e-SBI	Experimental	Single session, Electronic SBI for risky alcohol use Receives: Behavioral: Electronic SBI
Control	No intervention	Treatment as usual with only assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Risky Alcohol Use
Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day.
Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol
Measured: baseline, 3 months, 6 months
Number of Participants Reporting Weekly Alcohol Use
weekly alcohol use is defined as at least drinking once a week or more often
Measured: baseline, 3 month, 6 month
Number of Participants Reporting Heavy Alcohol Use
heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks
Measured: baseline, 3 month, 6 month

Secondary outcomes (4)

Number of Participants Reporting Any Tobacco Use
Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes
Measured: baseline , 3 months, 6 months
Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages
Measured: baseline, 3 months, 6 months
Number of Participants Reporting Significant Depression
Significant depression is measured as scoring above the cutoff of 6 on the total score on the 9 item Physician's health questionnaire (PHQ-9).
The 9-item Patient Health Questionnaire (PHQ-9) is a self-report measure of depression symptoms in the past two weeks. Scores can range from 0 to 27, with a score of 6 or more indicating significant depression symptoms in samples of childbearing age women.
Measured: baseline, 3 months, 6 months
Number of Participants Reporting Any Drug Use
Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months
Measured: baseline, 3 month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 201631 Aug 2018

First posted13 Jan 2015 (estimated)
Study start22 Feb 2016
Primary completion31 Aug 2017
Study completion31 Aug 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Foetal Exposure During PregnancyStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02337361
Sponsor's protocol ID: R34AA022697
Status last verified: Jan 2019
First submitted: 21 Oct 2014
Last updated: 25 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Nayak MB, Kaskutas LA, Mericle AA. Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age. J Addict Med. 2019 Nov/Dec;13(6):450-459. doi: 10.1097/ADM.0000000000000518.
PubMed 30882553

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial
ClinicalTrials.gov ID: NCT02337361
Acronym / sponsor ID: R34AA022697
Conditions: Foetal Exposure During Pregnancy
Keywords: risky alcohol use, pregnancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Public Health Institute, CaliforniaUniversity, hospital or other
Collaborators: Sonoma County Department of Health Services, La Clínica de La Raza Inc.
Study start: 22 Feb 2016 (actual)
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2018 (actual)
First posted: 13 Jan 2015 (estimated)
Results: Posted 23 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
e-SBI	Experimental	Behavioral: Electronic SBISingle session, Electronic SBI for risky alcohol use
Control	No intervention	–Treatment as usual with only assessment

Who may qualify

Ages: 18 to 44 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,

Key exclusion criteria (1 listed)

not fluent in english or spanish,

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
Electronic SBIBilingual (English and Spanish) e-SBI with four key components: 1) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.	Behavioural	e-SBI

Primary outcome

Number of Participants Reporting Risky Alcohol Use
Time frame: baseline, 3 months, 6 months
Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day. Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol
Number of Participants Reporting Weekly Alcohol Use
Time frame: baseline, 3 month, 6 month
weekly alcohol use is defined as at least drinking once a week or more often
Number of Participants Reporting Heavy Alcohol Use
Time frame: baseline, 3 month, 6 month
heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks

4 secondary outcomes

Number of Participants Reporting Any Tobacco Use
Time frame: baseline , 3 months, 6 months
Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
Time frame: baseline, 3 months, 6 months
Number of Participants Reporting Significant Depression
Time frame: baseline, 3 months, 6 months
Number of Participants Reporting Any Drug Use
Time frame: baseline, 3 month, 6 month

Results and safety

Results posted to the registry on 23 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
e-SBI	99	99
Control	86	86

Primary outcome: Number of Participants Reporting Risky Alcohol Use

Time frame: baseline, 3 months, 6 months. Count of participants. Unit: Participants

Measure	e-SBI n = 99	Control n = 86
baseline	99	86
3 month	60	48
6 month	45	41

Population analysed: 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time

Primary outcome: Number of Participants Reporting Weekly Alcohol Use

Time frame: baseline, 3 month, 6 month. Count of participants. Unit: Participants

Measure	e-SBI n = 99	Control n = 86
Baseline	22	14
3 month	17	16
6 month	9	16

Control: Odds Ratio (OR): 0.22, p <.01, t-test, 2 sided

Population analysed: 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time

Primary outcome: Number of Participants Reporting Heavy Alcohol Use

Time frame: baseline, 3 month, 6 month. Count of participants. Unit: Participants

Measure	e-SBI n = 99	Control n = 86
Baseline	19	16
3 month	14	18
6 month	7	16

Control: Odds Ratio (OR): 0.23, p <.05, t-test, 2 sided

Population analysed: Numbers at 3 and 6 month reflect participant attrition

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months, 6 months per participation, overall time frame includes screening for eligibility until the completion of the last (6-month follow-up) for the participants enrolled into the study last. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
e-SBI	0 of 99 (0%)	0 of 99 (0%)	0 of 99
Control	0 of 86 (0%)	0 of 86 (0%)	0 of 86

Limitations and caveats (from the sponsor): Participants in the e-SBI group were re-administered the brief intervention at 3-month follow-up if they reported any alcohol use at that follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30882553Nayak MB, Kaskutas LA, Mericle AA. Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age. J Addict Med. 2019 Nov/Dec;13(6):450-459. doi: 10.1097/ADM.0000000000000518.
Individual participant dataSharing planned: No

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.

Madhabika Nayak, Ph.D. principal investigator

Public Health Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electronic SBI in people with Foetal Exposure During Pregnancy, run by Public Health Institute, California at 2 sites 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 1 inclusion and 1 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 23 Jan 2019). 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?

Number of Participants Reporting Risky Alcohol Use (time frame: baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02337361, which also lists 1 linked publication.

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 25 Jan 2019.