Prevention of alcohol exposed pregnancies

1. Larissa Tsvetkova, PhD Vice Dean, St. Petersburg State University The First U.S.-Russia Scientific Forum for Biomedical and Behavioral Research Prevention of alcohol exposed pregnancies

2. Nizhny Novgorod State Pedagogical University Supported by Research Grants R21 TW006745 Brain Disorders in the Developing World: Research Across the Lifespan and R01AA016234, NIH/NIAAA/Fogarty Center and AUCD/CDC Grants RTOI 2005-999-01 and RTOI 2007-999-02 to Bonner and Balachova, OUHSC

3. Prevent FAS Research Team University of Oklahoma Health Sciences Center Tatiana Balachova, PhD Barbara Bonner, PhD Mark Chaffin, PhD Consultants Karen Beckman, MD, OUHSC Jacquelyn Bertrand, PhD, CDC Vladimir Shapkaitz, MD, PhD, Academy of Pediatrics Oleg Erishev, MD, PhD, BekhterevInstitute, St. Petersburg Alexander Palchick, MD, PhD, Academy of Pediatrics Edward Riley, PhD, San Diego State University Vladimir Shapkaitz, MD, PhD, Academy of Pediatrics Linda Sobell, PhD, Nova Southeastern University Michael Fleming, MD, MPH, University of Wisconsin St. Petersburg State University, Russia Larissa Tsvetkova, PhD Galina Isurina, PhD Vladimir Shapkaitz, MD, PhD, Academy of Pediatrics Alexander Palchik , MD, PhD, Academy of Pediatrics Nizhny Novgorod State Pedagogical University Elena Volkova, PhD Data Collectors in St. Petersburg and Nizhniy Novgorod Advisory Board Sheldon Levy, MPH, PhD, University of Miami John Mulvihill, MD, OUHSC Edward Riley, PhD, San Diego State University Kevin Rudeen, PhD, OUHSC Mark Wolraich, MD, OUHSC Elena Varavikova, MD, PhD, MPH,,CNIOIZ,Russia

4. Developing FASD prevention: International collaboration Phase I: Preventing FAS/ARND in Russian Children, 2003-2007 Supported by Grant R21 TW006745 Brain Disorders in the Developing World: Research Across the Lifespan, NIH Fogarty International Center/NAAA to Barbara Bonner at OUHSC Phase II: Development of Education Materials for Prevention of FAS in Russia, 2005-2007, supported by Research Grant RTOI 2005-999-01 AUCD/CDC to Barbara Bonner at OUHSC Health of Children in Russia: Providing Education on FAS/FASD, 2007-2008, supported by Research Grant RTOI 2007-999-02 AUCD/CDC, to Tatiana Balachova at OUHSC Phase III: Preventing FAS/ARND in Russian Children, 2007-2012 supported by Research Grant R01AA016234 NIAAA/Fogarty International Center to Tatiana Balachova at OUHSC

5. Phase I Objective Assess knowledge, attitudes, drinking behaviors, and receptivity to prevention necessary for developing a FAS/ARND primary prevention program in Russia

6. Phase I: study design Sample • Focus groups in spring 2004 • 7 groups of women, partners, women with alcohol dependency substance abuse treatment physicians, OBGs, Pediatricians (N=51) • Survey with 851 participants from St. Petersburg (SPB) and the Nizhniy Novgorod region (NNR) in fall 2004 - spring 2005 • 648 women recruited at women’s clinics: 301 pregnant and 347 non-pregnant • 203 physicians recruited at continuing education courses: 100 OBGs and 103 pediatricians

7. Results: Any alcohol use (Balachova et al., 2007)

8. Russia: Binge drinking (Balachova et al., 2007) p<0.05

9. Women At-risk for AEP (Prevent FAS in Russia Research group, 2007) (Project CHOICES Research Group, 2002)

10. Phase I: Results • Alarmingly high risk for AEP among nonpregnant women • After pregnancy recognition, a decline in consumption • Interventions by OBGs may be influential in preventing AEP • Physicians have limited knowledge and • Training for physicians and education materials for women were not available Photocourtesy of Dr. Bertrand

11. Phase II: Developing education materials for FASD prevention Objectives • Develop education materials for women and training for health professionals in Russia • Evaluate training materials in randomized trials • Develop and evaluate a web-based FASD education resource in the Russian language - for public (target women of childbearing age) and - for health professionals

12. Phase II: Developing training for health professionals Review medical schools and CME curricula to identify existing FASD training Translate the FAS Curriculum Framework and the Instructional Resource Handbook Review FASD materials available in Russia Select and translate additional training and reading materials on FASD Adapt and modify available materials to develop a curriculum for health professionals in Russia Train the trainers: Train the Russian project faculty

13. Education materials: FAS Diagnosis Lip-Philtrum Guide Astley, 2004 Russian translation by Balachova & Palchik (Prevent FAS in Russia Research Group) http://depts.washington.edu/fadu/International.html

14. Education materials: Dual-focused Brief Physician Intervention (DFBPI) Adaptation of two evidence-based FASD prevention approaches: • Brief physician intervention (Fleming & Mundt, 2006; NIAAA1999, 2005) and • Project CHOICES a motivational dual-focused intervention (Floyd et al., 2007) • If a woman is pregnant or planning pregnancy: The goal is abstaining from alcohol • If a woman is not contracepting consistently: the goal depends on the woman’s choice: • reducing alcohol consumption or/and • delaying pregnancy/contraception “If you wish to have a baby, don’t drink; if you drink, don’t have a baby!” (FAS-Russia study participant , 2005)

15. Randomized trials Sample 138 physicians (73 pediatricians and 65 OBGYN) from throughout Russia were recruited at a CME program at St. Petersburg Pediatric Academy in 2006-2008 Procedures • Groups of physicians (6 groups of pediatricians and 8 groups of OBGYN) were randomly assigned to intervention or control conditions • Participants in the experimental groups (EG) received a 3-hour training module on FASD • Participants in the control groups (CG) received a regular CME course • both groups received the same number of CME • Training included 1) presentations on FASD foundation competencies and 2) practicum in FAS diagnosis (pediatricians) or training in a brief intervention protocol (OBGYN)

16. Phase II: Developing education materials for women Focus groups to design brochures Sample: 35 women of childbearing age were recruited from public women’s clinics in St. Petersburg and Nizhniy Novgorod Evaluate brochures in a randomized trial Randomly assigned to 1 of 3 groups: Review the FAS prevention brochure with positive images (N=140), Review the FAS prevention brochure with negative images (N=140), Review a health material that is available at local clinics (N=140). Following the intervention, women complete a brief questionnaire One-month follow-up

17. Conclusions • The 3-hour FASD education modules included in CME for OBGYN and pediatricians were effective in improving physicians’ knowledge, attitudes, and targeted skills • OBGYN significantly increased their competence and skills in conducting the dual-focused brief intervention • FASD education brochures were effective in improving women’s knowledge and attitudes

18. Phase II : FASD Education website in Russian The FASD education website for the general public Internet-based FASD education for health professionals • http://NetFAS.net • http://NetFas.net/pro

19. Phase III: Reducing risk of alcohol-exposed pregnancies in childbearing age women A two-arm, 20-site, site-randomized clinical trial Evaluate DFBPI at OBGYN clinics • 764 participants in two regions • enrollment completed • ongoing follow-up: 3,6, and 12 months

20. Building Research Capacity • Research seminars, lectures for faculty and students, train-the-trainer workshops • Human Subject Protection • Training to SPSU and NNSPU faculty and students • Established Behavioral IRB at SPSU • Training and consultation to the IRB • Ongoing research supervision; weekly SKYPE meeting • Graduate psychology students participate in research activities • PhD students serve as coordinators on the study • Five PHD dissertations are in progress • Master thesis are being completed • Presentations at professional meetings • Publications are in progress • New collaborations with researchers from other universities have been initiated

21. Conclusions • FAS/ARND is a major public health problem in Russia • Women and professionals readily participate in research • International collaboration in research is challenging but productive Larissa@psy.pu.ru Tatiana-Balachova@ouhsc.edu