Prevention of alcohol exposed pregnancies

Larissa Tsvetkova, PhDVice Dean, St. Petersburg State University

The First U.S.-Russia Scientific Forum for Biomedical and Behavioral Research

TheUniversity of OklahomaHealth Sciences Center

OU St. Petersburg State UniversityNizhny Novgorod State Pedagogical University

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

Prevent FAS Research Team

University of Oklahoma Health Sciences CenterTatiana Balachova, PhDBarbara Bonner, PhDMark Chaffin, PhD

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

Consultants

Karen Beckman, MD, OUHSC

Jacquelyn Bertrand, PhD, CDC

Vladimir Shapkaitz, MD, PhD, Academy of Pediatrics

Oleg Erishev, MD, PhD, Bekhterev Institute, 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

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

Developing FASD prevention: International collaboration

Phase I: Preventing FAS/ARND in Russian Children, 2003-2007Supported 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

Phase I

Objective

Assess knowledge, attitudes, drinking behaviors,

and receptivity to prevention necessary for

developing a FAS/ARND primary prevention

program in Russia

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

Results: Any alcohol use

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Nonpregnant,N=347

Pregnant, N=301 Might becomepregnant, N=469

Trying toconceive, N=222

Proportion

SPB

NNR

(Balachova et al., 2007)

Russia: Binge drinking

0.55

0.660.61

0.28

0.77 0.770.72

0.47

0.060.021

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Nonpregnant,N=347

Pregnant,N=301

Might becomepregnant,N=469

Trying toconceive,N=222

Proportion SPB, any last 3 monthsSPB, once/month & more NNR, any last 3 monthNNR, once/month & more

p<0.05 (Balachova et al., 2007)

Women At-risk for AEP

13%

21%24%

9%5%

8%2%

32%

54%

0%

10%

20%

30%

40%

50%

60%

Total Jail RecoveryCenters

GYNClinic

HealthCenters

MediaSample

General Population

Russia,SPB

Russia,NNR

(Project CHOICES Research Group, 2002)(Prevent FAS in Russia Research group, 2007)

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

Phase I: Results

Photo courtesy of Dr. Bertrand

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

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

Education materials: FAS Diagnosis

Astley, 2004

Russian translation by Balachova & Palchik (Prevent FAS in Russia Research Group)

http://depts.washington.edu/fadu/International.html

Lip-Philtrum Guide

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:1) reducing alcohol consumption or/and2) 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)

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)

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

Fetal Alcohol Syndrome Fasstar Information Series Brochure 0201B1

FAS and the

Brain

(Photo courtesy of Sterling Clarren, MD)

Brain of normal baby Brain of baby with FAS

How Prenatal Alcohol Exposure Affects

Development of the Brain By Teresa Kellerman

Fasstar Enterprises Fetal Alcohol Syndrome: Support, Training, Advocacy, & Resources

www.fasstar.com

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

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/pro

http://NetFAS.net

Phase III: Reducing risk of alcohol-exposed pregnancies in childbearing age women

764 participants in two regions

enrollment completed ongoing follow-up:

3,6, and 12 months

A two-arm, 20-site, site-randomized clinical trial

Evaluate DFBPI at OBGYN clinics

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

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