IACC Subcommittee for Basic and Translational Research Planning Group for Question 4 Conference Call - October 18, 2012
|Date:||Thursday, October 18, 2012|
|Time:||10:00 a.m. to 11:00 a.m. Eastern|
|Agenda:||The planning group for Question 4 will discuss updates for the IACC Strategic Plan.|
|Place:||No in-person meeting; conference call only|
|Conference Call:||Dial: (888) 790-3358
Access code: 3025735
|Contact Person:||Ms. Lina Perez
Office of Autism Research Coordination
National Institute of Mental Health, NIH
6001 Executive Boulevard, NSC, Room 6182A
Rockville, Maryland 20852
Phone: (301) 443-6040
|Please Note:||For call-in issues, dial *0 so that an operator may assist you.
Schedule subject to change.
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No in-person meeting; conference call only.
|10:00 a.m.||Roll Call and Opening Remarks
Noah Britton, M.A.
Bunker Hill Community College
Co-Chair, Basic and Translational Research Question 4 Planning Group
Gemma Weiblinger – Designated Federal Official
National Institute of Mental Health (NIMH)
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The Interagency Autism Coordinating Committee (IACC) Subcommittee for Basic and Translational Research Strategic Plan Question 4 Planning Group convened a conference call on Thursday, October 18, 2012.
In accordance with Public Law 92-463, the meeting was open to the public. Mr. Noah Britton, M.A., Chair, presided.
Noah Britton, M.A., Chair, Bunker Hill Community College; Gemma Weiblinger, M.A., Designated Federal Official, National Institute of Mental Health (NIMH); Elizabeth Baden, Ph.D., Office of Autism Research Coordination (OARC), (NIMH); Anshu Batra, M.D., Our Special Kids; Tiffany Farchione, M.D., U.S. Food and Drug Administration (FDA); Matthew Goodwin, Ph.D., Northeastern University; Connie Kasari, Ph.D., University of California, Los Angeles; Beth Malow, M.D., M.S., Vanderbilt University Medical Center; and Linmarie Sikich, M.D., The University of North Carolina at Chapel Hill
Welcome, Roll Call, and Discussion
Ms. Gemma Weiblinger welcomed participants to the call on Question 4 (Which treatments and interventions will help?) of the Strategic Plan update. Mr. Noah Britton called the roll, welcomed participants, and asked for opinions about the information Planning Group members had received regarding the questions "What do we know?" and "What do we need?"
Dr. Connie Kasari noted that more rigorous trial designs are needed. Regarding "What do we know?" in the area of early intervention, she stated that comprehensive interventions have not targeted any of the core deficits, such as joint engagement and joint attention, although it is known that targeting these deficits has a long-term effect on outcomes.
Dr. Linmarie Sikich said that more objective outcome measures are needed that can be readily implemented across sites. Mr. Britton added that, although there was agreement about this, it could be difficult to do properly. Dr. Kasari noted that there should be a push for consensus about the kind of measures that are needed and a clear definition of "meaningful change." She also noted that pharmacological studies have shifted toward pilot studies to test the feasibility of larger trials.
Dr. Kasari said that the process of evaluating the effectiveness of behavioral interventions by repeating laboratory clinical trials in the community is too lengthy. Instead, she stated her belief that studies should be conducted in the community. Dr. Kasari then noted that, although the assessment of behavioral interventions should not move too fast, such assessment is key to testing interventions in the community, where a meaningful change may be seen. Mr. Britton commented that community studies need to be more rigorous, particularly behavioral studies, although it is important to be cautious in moving ahead too quickly because of possible harms. He agreed that more randomized controlled trials and more effective tests of interventions are needed that are already being used in the community.
Dr. Beth Malow stated that in some areas, such as medical comorbidities, the literature is very limited. Therefore, carefully done pilot trials are needed to prepare for Phase III trials. It was noted that it would be valuable to talk about partnering with other organizations such as foundations, community groups, and industry to develop consensus on outcome measures for clinical trials, whether behavioral or pharmacological. Participants also discussed the advantages and disadvantages of such partnerships and agreed it would be useful to sponsor such meetings. Dr. Sikich said the focus should be on the development of new objective assessments that are based on core behaviors since there has been limited progress in this regard.
Dr. Malow suggested using consensus conferences to move from parent-based measures to other measures. Dr. Kasari added that there has been movement in this area in the behavioral field, and Dr. Sikich commented that this important issue should stay on the radar.
Dr. Matthew Goodwin observed that participants have been thinking along similar lines regarding the need for better measurement and more consistent measurement across individuals, as well as multiple levels of measurement, to target treatment more effectively. He said that new technological capabilities would allow more objective, quantitative outcome measures that can be used unobtrusively in a natural environment. These would help in measuring autonomic nervous system response, sleep, seizure activity, motor movement impairment, anxiety, therapist-child relationships, and medication outcomes.
Currently, global surveys with behavior ratings are used because few direct physiological or physical activity measurements are available. Dr. Goodwin commented that this is a promising area that should be included in the Strategic Plan. Dr. Sikich noted that they could probably move forward with, for example, eye-tracking studies that measure social functioning. She also said that some of the voice-recording strategies currently geared only toward very young children could be used with a more extended age range.
Dr. Malow said that it was important to discuss how to integrate the different measures from different sources. Dr. Goodwin added that parent report, direct behavioral observation, and physiological data all may provide information about a construct of interest, although each provides different information.
Dr. Sikich stated that there are efforts to develop outcome toolkits for various disorders, including autism. Regarding bioinformatics, Dr. Goodwin noted that there is a general assumption that someone else has collected the needed data and that there is a need to think about data-collection devices and methods. Dr. Sikich said that the tool kits are the data collection methods and the outcome devices that should be used.
Dr. Malow suggested adding a sentence about new technologies and how new outcome measures would be integrated into parent reports and other measures. Dr. Goodwin noted that the literature he reviewed involved using technology for educational purposes, not as outcome measures, adding that it would be a good idea to pair toolkit development technologists with clinical providers rather than having the two groups function independently. He added that it is important to indicate that the measures would be complementary. In addition, the parent report would still be included but would be enhanced with other measures – a multifaceted approach that would include input from a variety of sources.
Mr. Britton summarized the discussion by saying that better measures are needed as are more studies done within the community where they will be used. Better toolkits of analytical methods and diagnostic tools are needed, as well as information about new technologies that could be useful as objective measures and that should be included with the parent and other reports to improve methods of analysis.
Dr. Goodwin discussed trial designs for technological programs to demonstrate effectiveness. He said that there is a good deal of technology but that little of it has been empirically validated. Future work should include individuals who are more severely affected by autism spectrum disorder and development and use of technology for better quantitative outcome measures of non-technological interventions.
Planning Group members noted that many people with autism—if given the choice to select their own activity—will gravitate toward computers, DVDs, iPads, and other interactive devices. Dr. Goodwin said that it is especially important to note that there are few data about the generalizability of skills acquired from computer-based interventions. Dr. Kasari said that transition is needed from device-based approaches to more human contact in the community as well as more interventions that combine human contact and technology.
Mr. Britton pointed out the need for more objective outcome measures, including those that are objective based and technology based. Dr. Sikich asked how to handle research with no current results. Dr. Anshu Batra said that ongoing studies should be mentioned in the update and that an end date should be provided if available. Participants discussed a number of ongoing studies of interventions, including melatonin and pharmacologic interventions coupled with acupuncture treatment, massage, and behavioral interventions.
Dr. Batra noted that the emphasis has been on medications, but the public wants other options. Dr. Kasari mentioned other non-medication treatments, including mindfulness and movement-based interventions. Mr. Britton agreed about the need to focus on other interventions besides drugs, including physical rehabilitation programs and sensory and motor-based interventions that look at autonomic controls.
Closing Remarks and Adjournment
Participants discussed the timing of the written pieces, and Dr. Baden noted that the draft should be submitted to her by close of business on Monday, October 22, 2012. Mr. Britton commented to Dr. Batra that he wanted to be sure the cautionary material that he mentioned in his review would be included. He thanked everyone for participating. The conference call was adjourned.
I hereby certify that this meeting summary is accurate and complete.
/Susan Daniels/ November 16, 2012
Susan A. Daniels, Ph.D.
Executive Secretary, Interagency Autism Coordinating Committee
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- Meeting Transcript (PDF - 191 KB)