Trial Outcomes & Findings for Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy (NCT NCT01643044)
NCT ID: NCT01643044
Last Updated: 2014-08-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
self-reported use during 90 days prior to delivery of their baby
Results posted on
2014-08-01
Participant Flow
Participant milestones
| Measure |
Alcohol Intervention
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.
Computer-delivered, brief intervention on alcohol use: 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.
|
Control
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Alcohol Intervention
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.
Computer-delivered, brief intervention on alcohol use: 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.
|
Control
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Miscarried baby
|
2
|
2
|
|
Overall Study
Delivered outside of hospital
|
1
|
2
|
Baseline Characteristics
Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
Baseline characteristics by cohort
| Measure |
Alcohol Intervention
n=24 Participants
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.
Computer-delivered, brief intervention on alcohol use: 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.
|
Control
n=24 Participants
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: 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.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: self-reported use during 90 days prior to delivery of their babyAlcohol 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.
Outcome measures
| Measure |
Alcohol Intervention
n=20 Participants
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.
Computer-delivered, brief intervention on alcohol use: 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.
|
Control
n=19 Participants
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Nutrition time control/placebo intervention: 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.
|
|---|---|---|
|
Alcohol Use
|
18 participants
|
14 participants
|
Adverse Events
Alcohol Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place