NCT02337361

Computerized Tool for Preventing Prenatal Drinking

Completed NA Results posted Last updated 25 January 2019

What this trial tests

NA trial testing Electronic SBI in Foetal Exposure During Pregnancy in 185 participants. Completed in 31 August 2018.

Timeline

22 February 2016

Primary endpoint
31 August 2017

31 August 2018

Quick facts

Lead sponsor	Public Health Institute, California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	185
Start date	22 February 2016
Primary completion	31 August 2017
Estimated completion	31 August 2018
Sites	2 locations across United States

Drugs / interventions tested

• Electronic SBI

Conditions studied

• Foetal Exposure During Pregnancy — all drugs for Foetal Exposure During Pregnancy →

Sponsor

Public Health Institute, California

Who can join

Adults 18 to 44, female only, with Foetal Exposure During Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting Risky Alcohol Use Primary · 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

baseline

Group	Value	95% CI
e-SBI	99
Control	86

3 month

Group	Value	95% CI
e-SBI	60
Control	48

6 month

Group	Value	95% CI
e-SBI	45
Control	41

Number of Participants Reporting Weekly Alcohol Use Primary · baseline, 3 month, 6 month

weekly alcohol use is defined as at least drinking once a week or more often

Baseline

Group	Value	95% CI
e-SBI	22
Control	14

3 month

Group	Value	95% CI
e-SBI	17
Control	16

6 month

Group	Value	95% CI
e-SBI	9
Control	16

Number of Participants Reporting Heavy Alcohol Use Primary · 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

Baseline

Group	Value	95% CI
e-SBI	19
Control	16

3 month

Group	Value	95% CI
e-SBI	14
Control	18

6 month

Group	Value	95% CI
e-SBI	7
Control	16

Number of Participants Reporting Any Tobacco Use Secondary · baseline , 3 months, 6 months

Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes

Baseline

Group	Value	95% CI
e-SBI	20
Control	16

3 month

Group	Value	95% CI
e-SBI	12
Control	11

6 month

Group	Value	95% CI
e-SBI	9
Control	13

Number of Participants Reporting Frequent Sugar Sweetened Beverage Use Secondary · baseline, 3 months, 6 months

Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages

Baseline

Group	Value	95% CI
e-SBI	65
Control	58

3 month

Group	Value	95% CI
e-SBI	55
Control	46

6 month

Group	Value	95% CI
e-SBI	41
Control	33

Number of Participants Reporting Significant Depression Secondary · baseline, 3 months, 6 months

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.

Baseline

Group	Value	95% CI
e-SBI	22
Control	11

3 month

Group	Value	95% CI
e-SBI	16
Control	12

6 month

Group	Value	95% CI
e-SBI	8
Control	11

Number of Participants Reporting Any Drug Use Secondary · baseline, 3 month, 6 month

Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months

Baseline

Group	Value	95% CI
e-SBI	12
Control	10

3 month

Group	Value	95% CI
e-SBI	8
Control	6

6 month

Group	Value	95% CI
e-SBI	9
Control	5

Sponsor's own description

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. Study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age.
   Nayak MB, Kaskutas LA, Mericle AA. · · 2019 · cited 7× · PMID 30882553 · DOI 10.1097/adm.0000000000000518