Fetal Alcohol Spectrum DisordersNCT01971398
Development of Education Materials for Prevention of FAS in Russia
A study testing Positive FASD education brochure, Negative FASD education brochure and Active comparator (a general women's health brochure) in people with Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome (FAS), run by University of Oklahoma at 3 sites in 2 countries.
Trial summary
This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder
- What is being tested?
- Positive FASD education brochure, Negative FASD education brochure and Active comparator (a general women's health brochure)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2007to Dec 2007
- 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
- Women
- Childbearing age (between 18 and 44 years of age)
- Sexually active (any intercourse with a partner in the last year)
- Consume alcohol (any level of alcohol consumption in the last year)
Who cannot join
- None
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Russia2 sites
Nizhny Novgorod State Pedagogical University
Nizhny Novgorod
St. Petersburg State University
Saint Peterburg
United States1 site
University of Oklahoma
Oklahoma City, Oklahoma, 73104
About this study
Official title: Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia
This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not precisely known. At this time, there are no programs to prevent FAS in Russia. The results of our previous study, focus groups with health professionals, pregnant women and their partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and print resources related to this topic. Based on the initial findings, this proposal aims to develop and evaluate in a clinical trial informational brochures for women to increase knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested are:
- 1. Compared to the control group (CG) of women who receive a standard locally available flyer with health recommendations, women in the experimental groups who are exposed to printed information on FAS will show significantly more knowledge about FAS, significantly less acceptance of any alcohol use during pregnancy, and reduced drinking at one month follow-up assessment.
- 2. The group exposed to a brochure with negative images (IGN - Intervention group with a "negative brochure") regarding drinking during pregnancy will show significantly greater change in the predicted directions compared to the group exposed to positive images (IGP - Intervention group with a "positive" brochure) at the one month follow-up assessment.
Read the detailed description
The study utilizes a randomized controlled trial design to test the two types of brochures (with positive vs. negative images and statements) to determine if either approach has more effect on women's alcohol consumption.
Pregnant and non-pregnant childbearing age women will be recruited at women's clinics and randomly assigned to participate in one of three groups: (1) participants will review the brochures that present information on FAS and alcohol use in pregnancy with positive images, (2) participants will review the brochures that that present information on FAS and alcohol use in pregnancy with negative, vivid images, and (3) participants will receive a general health information material that is available at their local clinics.
All study participants will complete a baseline survey assessing their attitudes toward drinking during pregnancy, knowledge of FAS, and current alcohol use. After that, the intervention will be conducted. The women in the two experimental groups will receive a brochure with either positive (IGP) or negative (IGN) images. The women will be asked to read one of two brochures in the presence of the data collector. If the participants ask questions, the data collector will redirect the participants to material in the brochure. Following the intervention, the women in the experimental groups will complete a brief questionnaire to assess their emotional responses to the materials and perceived effects. The women assigned to the control group (CG) will be asked to read a brochure on general aspects of women's' health. At a one-month follow-up, women in all three groups will complete a post-test of self-reported alcohol consumption, knowledge about prenatal effects of alcohol and FAS, and attitudes to drinking during pregnancy.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder, Alcohol Use Complicating Pregnancy, Unspecified Trimester
- Being tested
- Positive FASD education brochure, Negative FASD education brochure, Active comparator (a general women's health brochure)
- Keywords
- Fetal Alcohol Spectrum Disorders (FASD), Prevention, Alcohol-Exposed Pregnancy, Knowledge, Attitudes
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive FASD education brochureBehavioural
Exposure to a positive FASD education brochure
Negative FASD education brochureBehavioural
Exposure to a negative FASD education brochure
Active comparator (a general women's health brochure)Behavioural
Exposure to a general women's health brochure
| Study group | Role | What they receive |
|---|---|---|
| Positive Brochure | Experimental | Women receive a "positive" FASD education brochure with positive images and are asked to read this brochure in the presence of a data collector. Receives: Behavioral: Positive FASD education brochure |
| Negative Brochure | Experimental | Women receive a "negative" FASD education brochure with negative, vivid images and are asked to read this brochure in the presence of a data collector. Receives: Behavioral: Negative FASD education brochure |
| A general women's health brochure | Active comparator | Women receive a brochure on general aspects of women's health and pregnancy that is available in the Russian language and are asked to read this brochure in the presence of a data collector. Receives: Behavioral: Active comparator (a general women's health brochure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
A survey measure assessed knowledge about FAS
Measured: 1 month follow-up
Changes in attitudes from baseline
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Measured: 1 month follow-up
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: 1 month follow-up
Secondary outcomes (1)
Responses to brochures
A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures.
Measured: After the intervention (reading an information brochure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Tatiana Balachova, PhD, Principal investigator, University of OklahomaBarbara Bonner, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971398
- Sponsor's protocol ID
- RTO1 2005-999-01
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia
- ClinicalTrials.gov ID
- NCT01971398
- Acronym / sponsor ID
- RTO1 2005-999-01
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder, Alcohol Use Complicating Pregnancy, Unspecified Trimester
- Keywords
- Fetal Alcohol Spectrum Disorders (FASD), Prevention, Alcohol-Exposed Pregnancy, Knowledge, Attitudes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 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.
This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not precisely known. At this time, there are no programs to prevent FAS in Russia. The results of our previous study, focus groups with health professionals, pregnant women and their partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and print resources related to this topic. Based on the initial findings, this proposal aims to develop and evaluate in a clinical trial informational brochures for women to increase knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested are:
- 1. Compared to the control group (CG) of women who receive a standard locally available flyer with health recommendations, women in the experimental groups who are exposed to printed information on FAS will show significantly more knowledge about FAS, significantly less acceptance of any alcohol use during pregnancy, and reduced drinking at one month follow-up assessment.
- 2. The group exposed to a brochure with negative images (IGN - Intervention group with a "negative brochure") regarding drinking during pregnancy will show significantly greater change in the predicted directions compared to the group exposed to positive images (IGP - Intervention group with a "positive" brochure) at the one month follow-up assessment.
Detailed description
The study utilizes a randomized controlled trial design to test the two types of brochures (with positive vs. negative images and statements) to determine if either approach has more effect on women's alcohol consumption.
Pregnant and non-pregnant childbearing age women will be recruited at women's clinics and randomly assigned to participate in one of three groups: (1) participants will review the brochures that present information on FAS and alcohol use in pregnancy with positive images, (2) participants will review the brochures that that present information on FAS and alcohol use in pregnancy with negative, vivid images, and (3) participants will receive a general health information material that is available at their local clinics.
All study participants will complete a baseline survey assessing their attitudes toward drinking during pregnancy, knowledge of FAS, and current alcohol use. After that, the intervention will be conducted. The women in the two experimental groups will receive a brochure with either positive (IGP) or negative (IGN) images. The women will be asked to read one of two brochures in the presence of the data collector. If the participants ask questions, the data collector will redirect the participants to material in the brochure. Following the intervention, the women in the experimental groups will complete a brief questionnaire to assess their emotional responses to the materials and perceived effects. The women assigned to the control group (CG) will be asked to read a brochure on general aspects of women's' health. At a one-month follow-up, women in all three groups will complete a post-test of self-reported alcohol consumption, knowledge about prenatal effects of alcohol and FAS, and attitudes to drinking during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Brochure | Experimental | Behavioral: Positive FASD education brochureWomen receive a "positive" FASD education brochure with positive images and are asked to read this brochure in the presence of a data collector. |
| Negative Brochure | Experimental | Behavioral: Negative FASD education brochureWomen receive a "negative" FASD education brochure with negative, vivid images and are asked to read this brochure in the presence of a data collector. |
| A general women's health brochure | Active comparator | Behavioral: Active comparator (a general women's health brochure)Women receive a brochure on general aspects of women's health and pregnancy that is available in the Russian language and are asked to read this brochure in the presence of a data collector. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- Childbearing age (between 18 and 44 years of age)
- Sexually active (any intercourse with a partner in the last year)
- Consume alcohol (any level of alcohol consumption in the last year)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Positive FASD education brochureExposure to a positive FASD education brochure | Behavioural | Positive Brochure |
| Negative FASD education brochureExposure to a negative FASD education brochure | Behavioural | Negative Brochure |
| Active comparator (a general women's health brochure)Exposure to a general women's health brochure | Behavioural | A general women's health brochure |
Primary outcome
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
Time frame: 1 month follow-up
A survey measure assessed knowledge about FAS
Changes in attitudes from baseline
Time frame: 1 month follow-up
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Changes in alcohol consumption from baseline
Time frame: 1 month follow-up
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.
1 secondary outcome
Responses to brochures
Time frame: After the intervention (reading an information brochure)
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 29 Oct 2013.
Related trials for Fetal Alcohol Spectrum Disorders
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FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
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Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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The Synchrony Study: Examining Music Training for Children With FASD
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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.
Tatiana Balachova, PhD principal investigator
University of Oklahoma
Barbara Bonner, PhD principal investigator
University of Oklahoma
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive FASD education brochure, Negative FASD education brochure and Active comparator (a general women's health brochure) in people with Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome (FAS), run by University of Oklahoma at 3 sites in 2 countries.
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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia, United States. 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?
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline (time frame: 1 month follow-up). 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?
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 29 Oct 2013.