Trial Outcomes & Findings for The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology (NCT NCT04026620)
NCT ID: NCT04026620
Last Updated: 2024-10-08
Results Overview
The AUDIT is a 10-item, self-report, screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The AUDIT was developed and adopted by the World Health Organization. AUDIT scoring for questions 1 to 8 are scored on a five-point scale from 0,1,2,3, or 4; questions 9 and 10 are scored on a three-point scale from 0,2, or 4. The minimum total score for the AUDIT is 0. The maximum total score for the AUDIT is 40. Interpretation of the AUDIT Total Score is as follows: 0-7 indicates a low-risk level; a score of 8-15 is risky or hazardous level; a score of 16-19 is a high-risk or harmful level; and 20 or more is considered high-risk/almost certainly dependent on alcohol.
COMPLETED
NA
167 participants
Baseline through 9 months post-partum, an average of approximately 67 weeks.
2024-10-08
Participant Flow
Participant milestones
| Measure |
Pamphlet-only
Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans).
Informational Pamphlet: The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
|
MET Group
MET women will be provided with a one (1) hour and 30 minute session of Motivational Enhancement Therapy (MET) and informational pamphlet(s) (both in Afrikaans).
Informational Pamphlet: The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
Brief Motivational Enhancement Therapy (MET) Session: The case control trial/efficacy study will provide a one-session MET session in Afrikaans (the predominant language of the region). The face-to-face session will provide information to help people and pregnant women who want to change their drinking behavior, become 'dry' and stay motivated to change their drinking behaviors. Sessions will be approximately one (1) hour and 30 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
85
|
|
Overall Study
COMPLETED
|
71
|
68
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
Baseline characteristics by cohort
| Measure |
Pamphlet-only
n=82 Participants
Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans).
Informational Pamphlet: The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
|
MET Group
n=85 Participants
MET women will be provided with a one (1) hour and 30 minute session of Motivational Enhancement Therapy (MET) and informational pamphlet(s) (both in Afrikaans).
Informational Pamphlet: The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
Brief Motivational Enhancement Therapy (MET) Session: The case control trial/efficacy study will provide a one-session MET session in Afrikaans (the predominant language of the region). The face-to-face session will provide information to help people and pregnant women who want to change their drinking behavior, become 'dry' and stay motivated to change their drinking behaviors. Sessions will be approximately one (1) hour and 30 minutes.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
26.5 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
26.4 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
80 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
82 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through 9 months post-partum, an average of approximately 67 weeks.The AUDIT is a 10-item, self-report, screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The AUDIT was developed and adopted by the World Health Organization. AUDIT scoring for questions 1 to 8 are scored on a five-point scale from 0,1,2,3, or 4; questions 9 and 10 are scored on a three-point scale from 0,2, or 4. The minimum total score for the AUDIT is 0. The maximum total score for the AUDIT is 40. Interpretation of the AUDIT Total Score is as follows: 0-7 indicates a low-risk level; a score of 8-15 is risky or hazardous level; a score of 16-19 is a high-risk or harmful level; and 20 or more is considered high-risk/almost certainly dependent on alcohol.
Outcome measures
| Measure |
Pamphlet-only
n=71 Participants
Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans).
Informational Pamphlet: The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
|
MET Group
n=68 Participants
MET women will be provided with a one (1) hour and 30 minute session of Motivational Enhancement Therapy (MET) and informational pamphlet(s) (both in Afrikaans).
Informational Pamphlet: The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
Brief Motivational Enhancement Therapy (MET) Session: The case control trial/efficacy study will provide a one-session MET session in Afrikaans (the predominant language of the region). The face-to-face session will provide information to help people and pregnant women who want to change their drinking behavior, become 'dry' and stay motivated to change their drinking behaviors. Sessions will be approximately one (1) hour and 30 minutes.
|
|---|---|---|
|
Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time
|
-5.8 score on a scale
Standard Deviation 6.7
|
-4.0 score on a scale
Standard Deviation 7.5
|
Adverse Events
Pamphlet-only
MET Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Julie Hasken, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place