Fetal Alcohol Syndrome (FAS)NCT01961050
Preventing FAS/ARND in Russian Children
A study testing Dual-Focused Brief Physician Intervention (DFBPI) and Services as usual in people with Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Spectrum Disorders, run by University of Oklahoma at 2 sites in Russia.
Trial summary
The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
- What is being tested?
- Dual-Focused Brief Physician Intervention (DFBPI) and Services as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 767 participants
- Where
- 2 sitesRussia
- Study dates
- Sep 2007to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- nonpregnant women
- childbearing age (between 18 and 44 years of age)
- fertile
- at risk for an alcohol-exposed pregnancy: drinking at-risk (4 or more drinks on one occasion or more than 7 drinks per week)in the last 3 months and report having unprotected intercourse at least once in the last 6 months
Who cannot join
- unable comprehend interview questions
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Women's Clinics
Nizhny Novgorod, 603950
Women's clinics
Saint Peterburg, 199034
About this study
The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children. The study will determine whether physicians, trained in a dual-focused brief motivational intervention and monitored for performance, can foster greater change in knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women who are at risk than standard care.
Read the detailed description
The study is a two-arm, 20-site, site-randomized, controlled trial testing an intervention to reduce risk for alcohol-exposed pregnancies in at-risk women (at-risk drinking childbearing age women who are heterosexually active, and not consistently using contraception). The trial will assess feasibility of a dual-focused (i.e. contraception use-drinking reduction) brief physician intervention (DFBPI) and determine whether physicians, trained in DFBPI and monitored for compliance, can foster greater reduction of women's risk behaviors compared to standard care. The intervention is specifically designed to be deliverable routinely by Obstetrics and Gynecology physicians(OB/GYN) to large numbers of women at women's clinics.
- Conditions
- Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
- Being tested
- Dual-Focused Brief Physician Intervention (DFBPI), Services as usual
- Keywords
- alcohol, pregnancy, fetal exposure, prevention, FAS, Alcohol-Related Neurodevelopmental Disorder (ARND)
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Focused Brief Physician Intervention (DFBPI)Behavioural
The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits.
Services as usualOther
Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dual-Focused Brief Physician Intervention (DFBPI) Receives: Behavioral: Dual-Focused Brief Physician Intervention (DFBPI) |
| Standard care | Other | Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided. Receives: Other: Services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months
Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
Measured: 3 months
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months
Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
Measured: 6 months
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months
Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
Measured: 12 months
Secondary outcomes (3)
Changes in alcohol consumption from baseline
Interviews assessed self-reported quantity/frequency of alcohol consumption and frequency of binge drinking and a detailed alcohol consumption report was received utilizing the Time Line Follow Back (TLFB) measure.
Measured: 3 months, 6 months, and 12 months follow-up
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
A survey measure assessed knowledge about FAS
Measured: 3 months, 6 months, and 12 months follow-up
Changes in Health beliefs and attitudes from baseline
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Measured: 3 months, 6 months, and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startSep 2007
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Syndrome (FAS)Studies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Fogarty International Center of the National Institute of Health, St. Petersburg State Pavlov Medical University, Nizhny Novgorod State Pedagogical University
- Responsible party
- Sponsor
- Investigators
- Tatiana Balachova, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961050
- Sponsor's protocol ID
- R01AA016234_IRB 2758
- Other IDs
- 5R01AA016234
- Status last verified
- Feb 2016
- First submitted
- 8 Oct 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balachova T, Bonner BL, Chaffin M, Isurina G, Shapkaitz V, Tsvetkova L, Volkova E, Grandilevskaya I, Skitnevskaya L, Knowlton N. Brief FASD prevention intervention: physicians' skills demonstrated in a clinical trial in Russia. Addict Sci Clin Pract. 2013 Jan 8;8(1):1. doi: 10.1186/1940-0640-8-1.
PubMed 23294846
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing FAS/ARND in Russian Children
- ClinicalTrials.gov ID
- NCT01961050
- Acronym / sponsor ID
- R01AA016234_IRB 2758
- Conditions
- Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
- Keywords
- alcohol, pregnancy, fetal exposure, prevention, FAS, Alcohol-Related Neurodevelopmental Disorder (ARND)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Fogarty International Center of the National Institute of Health, St. Petersburg State Pavlov Medical University, Nizhny Novgorod State Pedagogical University
- Study start
- Sep 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children. The study will determine whether physicians, trained in a dual-focused brief motivational intervention and monitored for performance, can foster greater change in knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women who are at risk than standard care.
Detailed description
The study is a two-arm, 20-site, site-randomized, controlled trial testing an intervention to reduce risk for alcohol-exposed pregnancies in at-risk women (at-risk drinking childbearing age women who are heterosexually active, and not consistently using contraception). The trial will assess feasibility of a dual-focused (i.e. contraception use-drinking reduction) brief physician intervention (DFBPI) and determine whether physicians, trained in DFBPI and monitored for compliance, can foster greater reduction of women's risk behaviors compared to standard care. The intervention is specifically designed to be deliverable routinely by Obstetrics and Gynecology physicians(OB/GYN) to large numbers of women at women's clinics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)Dual-Focused Brief Physician Intervention (DFBPI) |
| Standard care | Other | Other: Services as usualServices as usual including standard OB/GYN clinic visits; no experimental intervention is provided. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- nonpregnant women
- childbearing age (between 18 and 44 years of age)
- fertile
- at risk for an alcohol-exposed pregnancy: drinking at-risk (4 or more drinks on one occasion or more than 7 drinks per week)in the last 3 months and report having unprotected intercourse at least once in the last 6 months
Key exclusion criteria (1 listed)
- unable comprehend interview questions
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 |
|---|---|---|
| Dual-Focused Brief Physician Intervention (DFBPI)The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits. | Behavioural | Intervention |
| Services as usualActive Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual. | Other | Standard care |
Primary outcome
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months
Time frame: 3 months
Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months
Time frame: 6 months
Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months
Time frame: 12 months
Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
3 secondary outcomes
Changes in alcohol consumption from baseline
Time frame: 3 months, 6 months, and 12 months follow-up
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
Time frame: 3 months, 6 months, and 12 months follow-up
Changes in Health beliefs and attitudes from baseline
Time frame: 3 months, 6 months, and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Results publication: PubMed 23294846Balachova T, Bonner BL, Chaffin M, Isurina G, Shapkaitz V, Tsvetkova L, Volkova E, Grandilevskaya I, Skitnevskaya L, Knowlton N. Brief FASD prevention intervention: physicians' skills demonstrated in a clinical trial in Russia. Addict Sci Clin Pract. 2013 Jan 8;8(1):1. doi: 10.1186/1940-0640-8-1.
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.
Tatiana Balachova, PhD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Focused Brief Physician Intervention (DFBPI) and Services as usual in people with Fetal Alcohol Syndrome (FAS) and Fetal Alcohol Spectrum Disorders, run by University of Oklahoma at 2 sites in Russia.
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 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 19 Feb 2016. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months (time frame: 3 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 NCT01961050, 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 19 Feb 2016.