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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive FASD education brochure | Behavioral | Exposure to a positive FASD education brochure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline | A survey measure assessed knowledge about FAS | 1 month follow-up |
| Changes in attitudes from baseline | A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy | 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. | 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Responses to brochures | A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures. | After the intervention (reading an information brochure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana Balachova, PhD | University of Oklahoma | Principal Investigator |
| Barbara Bonner, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States | ||
| Nizhny Novgorod State Pedagogical University |
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| Negative FASD education brochure | Behavioral | Exposure to a negative FASD education brochure |
|
| Active comparator (a general women's health brochure) | Behavioral | Exposure to a general women's health brochure |
|
| Nizhny Novgorod |
| Russia |
| St. Petersburg State University | Saint Peterburg | Russia |
| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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