Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) Progress Reports June 2005 Presented CIFASD Steering Committee Meeting Santa Barbara, CA June 23-24, 2005

Progress Report for Administrative Core The Specific Aims of the Consortium are as follows. Establish procedures for better defining the range of outcomes from prenatal alcohol exposure. Build upon existing research programs on FASD to meet this outcome. Establish a basic science program assessing mechanisms of alcohol damage and translate this work into effective interventions. Attract new and innovative investigators to the study of FASD by recruiting individuals for the development of U01 grants and pilot projects. Secure additional funding to implement innovative interventions and treatment strategies on a wide scale. Make available the data collected through this consortium to all interested parties.

Accomplishments and Results A consortium website is functioning and continues to be enhanced. Contains forms, manuals, database entry forms, tests, minutes, progress reports, etc. Regular monthly phone conference calls have been convened. These conference calls are available verbatim on the consortium website. New teleconferencing tool has been established, which will facilitate data sharing and discussion across multiple sites

Accomplishments and Results Twice annual meetings of the consortium PIs have been convened. Minutes from these meetings are available on the website.Conference Meeting Minutes March 9, 2004 April 29, 2004 June 3, 2004 June 24 - 25, 2004 (Annual Meeting at Vancouver) July 29, 2004 September 23, 2004 (click here to listen) October 28, 2004 (click here to listen) November 19, 2004 (click here to listen) December 15, 2004 (click here to listen) February 24, 2005 (click here to listen) March 24, 2005 April 21, 2005 *You will need Adobe Reader installed to view the files. To download Adobe Reader, click here. **You can listen to the audio file in either Windows Media Player or Winamp. To download Winamp, click here. Administrative core has financed parts of projects when funds were not available in the budget of the project

Accomplishments and Results The PI has given several talks about the consortium and has recruited new sites interested in joining the consortium or that will utilize the forms, tests, etc. created by the consortium. We have been approached by scientists in Australia, England, Germany, Japan, and the Reunion Islands about obtaining information about the consortium, our pilot project program, and to provide forms, manuals, etc. to the international research community. Pilot projects have been reviewed and four new projects will receive funding Publications are being posted online Listservs are in place in cooperation with the Informatics Core.

Progress Report for Pilot Project Core The Specific Aims of the Consortium are as follows. Establish procedures for better defining the range of outcomes from prenatal alcohol exposure. Build upon existing research programs on FASD to meet this outcome. Establish a basic science program assessing mechanisms of alcohol damage and translate this work into effective interventions. Attract new and innovative investigators to the study of FASD by recruiting individuals for the development of U01 grants and pilot projects. Secure additional funding to implement innovative interventions and treatment strategies on a wide scale. Make available the data collected through this consortium to all interested parties.

Progress Report for Pilot Project Core The Pilot Project Core provides a mechanism by which the consortium acts as a dynamic entity. It provides a flexible means for developing and exploring new research activities and directions for the Consortium and a mechanism by which new sites can be added or projects can evolve into independently funded research projects. Four pilot projects are currently funded and new projects have been reviewed and will be funded this next year. The emphasis on the new projects was that they fit in with the overall aims of the consortium and that they be able to accomplish their specific aims in one year. However, providing additional funding for ongoing pilot and regular projects that wanted to expand based upon current findings from the consortium was also considered.

Progress Report for Pilot Project Core IV. Methods Four independent projects are described in the next section, each presenting its objectives, methods, accomplishments and goals. New projects have been successfully solicited, but in contrast to the objectives outlined in the proposal, the Steering Committee for the consortium decided to solicit proposals only from members or associates of the consortium. Proposals were submitted online via the CIFASD website and reviewed by an independent committee, Chaired by Dr. James West of Texas A&M University. V. Accomplishments and Results The major accomplishment in the administration of the Pilot Project Core has been the solicitation and review of new proposals. Submission is via online at the website. New proposals have been reviewed and projects will be announced by the end of June. Each of the currently funded projects provides updates following this section.

Progress Report for Pilot Project Core One RO1 submission has resulted from the project at the University of Washington. Several posters and publications have been submitted from the projects.

Progress Report for Neurobehavioral Core The Specific Aims of the Neurobehavioral Core are: To provide a battery of scientific and psychometrically appropriate neurodevelopmental tests that can be used cross-culturally in the assessment of outcomes specifically affected by prenatal alcohol exposure. To establish a testing resource that will manage to test equipment and facilitate training, as appropriate, and monitor reliability of administration of tests, as necessary. To establish a collaborative database of testing outcomes to allow the eventual development of a valid neurodevelopmental profile or profiles of FAS and other FASD. Such a profile will allow the more sensitive diagnosis of affected individuals from birth through adulthood and will provide the basis for the development of effective strategies for the treatment of primary disabilities and the prevention of the secondary disabilities that are commonly associated with FASD.

Accomplishments and Results Convened meetings to develop the neurobehavioral test battery. Purchased all tests and forms and distributed them to the test sites. Developed a test manual and placed it on the web. Placed all of the tests on the web. Provided translation services for the test battery Developed database to be implemented by Informatics Core Video clips of each test are available on the website. Administration Manual & Test Packet are being updated and modified.

Accomplishments and Results A Scoring Manual is being created for examiners and re-checkers. This will ensure greater accuracy in scoring. The creation of Helpful Hints sheets: For each test there will be a one-page sheet filled with helpful hints and answers to questions many sites have asked. The creation of a FAQ sheet for each test.

Appendix 1. Protocol for Neurobehavioral Core Protocol for Neurobehavioral Core Train using Administration Manual and standardized procedures1 Send pilot tape/DVD and copy of protocol with translated transcript to San Diego2 San Diego site will review tape/DVD and protocol within 2 weeks of receipt and return to site Send second pilot tape/DVD and copy of protocol with translated transcript to San Diego2 Adjust administration and re-submit pilot tape/DVD if necessary Collect data using Administration Manual and standardized procedures Score protocols using Scoring Manual and standardized procedures1 Each file should be scored by the examiner and one additional person Rechecker forms are included in scoring manual First 10 cases: submit data only to Informatics Core for review of reliability Key data into Access Database Input Tool Export from Access to XML file Upload XML file to Central Repository website3

Appendix 1. Protocol for Neurobehavioral Core Protocol for Neurobehavioral Core Remaining cases: submit every 10th case to San Diego site (copy of scored protocol, video tape/DVD, translated transcript) San Diego site will review and return protocol within 2 weeks of receipt. Video will be destroyed unless return is requested Submit data to the Informatics core weekly Key data into Access Database Input Tool Export from Access to XML file Upload XML file to Central Repository website3 website for neurobehavioral materials: http://www.cifasd.org/FTP/Neurobehavioral.htm Address for submission: Sarah N. Mattson Center for Behavioral Teratology 6363 Alvarado Court, Suite 209 San Diego, CA 92120 Phone: 619-594-7228 Email: smattson@sunstroke.sdsu.edu website to be announced