Fetal Alcohol Spectrum DisordersNCT04026620
The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
A study testing Informational Pamphlet and Brief Motivational Enhancement Therapy (MET) Session in people with Fetal Alcohol Spectrum Disorders, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
Trial summary
Screen women of childbearing age (15 - 44 years) for high risk drinking in antenatal clinics of the established research sites in the Western Cape Province of South Africa (SA). While there are multiple reasons for this screening, the purpose is for selective (secondary) prevention of FASD. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Informational Pamphlet and Brief Motivational Enhancement Therapy (MET) Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteSouth Africa
- Study dates
- 6 Aug 2019to 10 Oct 2023
- 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 15 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Drinking pregnant women who are defined as women who:
- Drank in the 3 months prior to pregnancy and/or
- Drank alcohol at least once at any time during the prenatal period.
- Gestational age less than or equal to 16 weeks, but not more than 20 weeks at intake
Who cannot join
- Non-drinking pregnant women who are defined as women who have not had any alcohol during the past 30 days.
- Gestational age >20 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Screen women of childbearing age (15 - 44 years) for high risk drinking in antenatal clinics of the established research sites in the Western Cape Province of South Africa (SA). While there are multiple reasons for this screening, the purpose is for selective (secondary) prevention of FASD. A.) Initiate a case control trial/efficacy study (n=400) of the use of one-session brief motivation enhancement therapy (MET) in busy public health settings (versus information only) in these rich research sites where very high rates of FASD have been documented over the entirety of the past two decades. B.) These targeted prevention activities follow both findings and staff experience in prevention over the past decade which indicate that the most likely venue for prevention activities is in antenatal clinics of the local, primary care clinics and hospitals. These activities will also provide tangible community-level pay back for participation in ongoing research activities and lay the groundwork for sustainable services going forward.
Read the detailed description
The purpose of the research is to find out if Motivational Enhancement Therapy is more effective than printed information alone (Informational pamphlets only) in helping women reduce their risk of giving birth to children with Fetal Alcohol Spectrum Disorders (FASD) at Primary Health Care Facilities, in addition to evaluation individuals for risky health behaviors by having them complete brief screening questionnaires that give them information of how much risk they might be facing from their alcohol or other drug use. When a pregnant mother drinks alcohol, she puts her baby at risk. FASD is a group of growth, mental, and physical problems that may occur in a baby when a mother drinks alcohol during pregnancy.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Informational Pamphlet, Brief Motivational Enhancement Therapy (MET) Session
- Keywords
- alcohol use and abuse, prenatal alcohol use
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational PamphletBehavioural
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) SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pamphlet-only | Other | Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans). Receives: Behavioral: Informational Pamphlet |
| MET Group | Other | 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). Receives: Behavioral: Informational Pamphlet; Behavioral: Brief Motivational Enhancement Therapy (MET) Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time
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.
Measured: Baseline through 9 months post-partum, an average of approximately 67 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start6 Aug 2019
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
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 Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Model description
- A total of 400 women who screen positive for drinking will be asked if they want to be enrolled in the efficacy trial. Once a participant enrolls into the efficacy trial study, they are then randomly assigned to either the MET (Motivational Enhancement Therapy) group or informational pamphlet-only group. The MET group will be provided: 1.) a one (1) hour and 30 minute MET session, 2.) an information pamphlet on FASD written in simple Afrikaans. Women in the control condition will receive two informational pamphlets (one on FASD advising abstinence from alcohol use and one describing fetal development, both in Afrikaans). The data obtained by nurses during a woman's initial prenatal clinic visit for all 400 participants (Self-administered Questionnaire and AUDIT), will be matched with deliveries of the newborns to monitor the birth outcomes of newborns of participating mothers.
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, University of New Mexico, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Philip A May, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026620
- Sponsor's protocol ID
- 12-1827
- Other IDs
- 5R01AA015134
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2019
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
- ClinicalTrials.gov ID
- NCT04026620
- Acronym / sponsor ID
- 12-1827
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- alcohol use and abuse, prenatal alcohol use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Stellenbosch, University of New Mexico, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Screen women of childbearing age (15 - 44 years) for high risk drinking in antenatal clinics of the established research sites in the Western Cape Province of South Africa (SA). While there are multiple reasons for this screening, the purpose is for selective (secondary) prevention of FASD. A.) Initiate a case control trial/efficacy study (n=400) of the use of one-session brief motivation enhancement therapy (MET) in busy public health settings (versus information only) in these rich research sites where very high rates of FASD have been documented over the entirety of the past two decades. B.) These targeted prevention activities follow both findings and staff experience in prevention over the past decade which indicate that the most likely venue for prevention activities is in antenatal clinics of the local, primary care clinics and hospitals. These activities will also provide tangible community-level pay back for participation in ongoing research activities and lay the groundwork for sustainable services going forward.
Detailed description
The purpose of the research is to find out if Motivational Enhancement Therapy is more effective than printed information alone (Informational pamphlets only) in helping women reduce their risk of giving birth to children with Fetal Alcohol Spectrum Disorders (FASD) at Primary Health Care Facilities, in addition to evaluation individuals for risky health behaviors by having them complete brief screening questionnaires that give them information of how much risk they might be facing from their alcohol or other drug use. When a pregnant mother drinks alcohol, she puts her baby at risk. FASD is a group of growth, mental, and physical problems that may occur in a baby when a mother drinks alcohol during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 400 women who screen positive for drinking will be asked if they want to be enrolled in the efficacy trial. Once a participant enrolls into the efficacy trial study, they are then randomly assigned to either the MET (Motivational Enhancement Therapy) group or informational pamphlet-only group. The MET group will be provided: 1.) a one (1) hour and 30 minute MET session, 2.) an information pamphlet on FASD written in simple Afrikaans. Women in the control condition will receive two informational pamphlets (one on FASD advising abstinence from alcohol use and one describing fetal development, both in Afrikaans). The data obtained by nurses during a woman's initial prenatal clinic visit for all 400 participants (Self-administered Questionnaire and AUDIT), will be matched with deliveries of the newborns to monitor the birth outcomes of newborns of participating mothers.
| Arm | Type | Receives |
|---|---|---|
| Pamphlet-only | Other | Behavioral: Informational PamphletPamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans). |
| MET Group | Other | Behavioral: Informational Pamphlet, Behavioral: Brief Motivational Enhancement Therapy (MET) SessionMET 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). |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Drinking pregnant women who are defined as women who:
- Gestational age less than or equal to 16 weeks, but not more than 20 weeks at intake
Key exclusion criteria (2 listed)
- Non-drinking pregnant women who are defined as women who have not had any alcohol during the past 30 days.
- Gestational age >20 weeks
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 |
|---|---|---|
| Informational PamphletThe 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. | Behavioural | MET Group, Pamphlet-only |
| Brief Motivational Enhancement Therapy (MET) SessionThe 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. | Behavioural | MET Group |
Primary outcome
Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Philip A May, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Pamphlet and Brief Motivational Enhancement Therapy (MET) Session in people with Fetal Alcohol Spectrum Disorders, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
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 4 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 8 Oct 2024. 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 South Africa. 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 8 Oct 2024). 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?
Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time (time frame: Baseline through 9 months post-partum, an average of approximately 67 weeks.). 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 8 Oct 2024.