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 September 2003 NCSAC Meeting Minutes Appendix D

Appendix D
National Children’s Study Advisory Committee Meeting 7 th Meeting
Thematic Sub-Group Breakout Meeting Summary: Altered Neurobehavioral Development, Developmental Disabilities, and Psychiatric Outcomes
September 15, 2003
Holiday Inn Select
Bethesda, MD

Chair: M. Anne Spence, Ph.D., University of California, Irvine

Data Collection

Dr. Spence began the discussion with the observation that key hypotheses may not be initially identifiable, but capturing data on exposures and outcomes early is important. The Study design is complicated by the exceptionally broad range of ethnic groups and geographic distribution, and by the huge array of gene possibilities. Merely obtaining DNA samples on a large population will not be useful without developing a focused study plan.

Recommendation: Consult with the Gene-Environment Interactions Working Group regarding defining what is important in this regard, and what kind of genetics should be studied.

Gene-Environment Interactions Working Group

Christine Bachrach, Ph.D., NICHD, NIH, DHHS, suggested asking the Gene-Environment Interactions Working Group to develop a framework for a hypothesis or developmental outcome (although members of that Working Group may not actually have the requisite expertise). Participants discussed soliciting technical assistance from outside experts.

Dr. Spence identified a potential participant, Duncan Thomas (UCLA), who has developed some data on gene environment interaction modeling, although his work is mainly theoretical and he has not developed family-based data to test the model. Another candidate would be someone from the St. Louis group (for example, John Rice, Brian Suarez, Ross Newman), who has conducted some large-scale studies on alcoholism and who understands the challenges related to data collection.

Recommendations:

  • Consider conducting a workshop to lay the foundation for developing a hypothesis.
  • Consider identifying an outside expert to assist or participate in the Working Group.

Study Questions

Dr. Spence posed a number of questions:

  • What are the Sub-Group concerns about what the Gene-Environment Interactions Working Group should address?
  • Could the other Working Groups agree on what studies can be practically and reasonably designed?
  • How important a role should genetics play in the Study (which is not inherently a genetics study)?
  • Should the genetics segment extend to siblings? This would significantly increase the value of the Study, but might dilute the target population for the main part of the Study.
  • Should every Working Group consider including siblings and/or multiple births?

Participants agreed that responses from the Working Groups regarding including siblings would likely be mixed with a number of positive and neutral responses. Participants also recognized that one or more Working Groups might specifically object for one reason or another (for example, dilution of the "real" sample since the total sample will be limited by funding).

Clarifying/Refining Hypotheses

There was an observation that, for most of the hypotheses, timing is important: the ability to sort out when to sample, what to measure, and how to develop a plan that includes a rationale for analysis (how and when). Clarification of the sample is needed, as well as a comment on the relevance of siblings in the genetics area.

There is also a need to clarify hypotheses 19 through 21, and especially hypotheses 20 concerning autism Marshalyn Yeargin-Allsopp, M.D., ICC Member, CDC, DHHS, noted that a major collaborative study on autism is being established. This research may help identify the specific genes that may be most appropriate to the Study.

Dr. Spence suggested that a valid focused gene environment study appropriate to the Study would be an assessment of the risk in pregnant women related to genotype reaction to folate. In addition, the diabetes study, similar in concept to the folate study, looks at environmental exposures vis-à-vis children who are genetically susceptible to diabetes. However, in the hypothesis, genetic susceptibility and environmental exposure are inadequately defined.

Dr. Bachrach commented that it would be useful to determine whether gene environment issues were being addressed with respect to the key outcome areas, such as asthma, obesity, diabetes, and neurodevelopment.

Recommendations:

  • Direct specific questions to the Gene-Environment Interactions Working Group.
  • Clarify hypotheses 19–21, especially hypotheses 20.
  • The hypothesis concerning stress and asthma may be too narrow; the candidate genes should be expanded.
  • The Nutrition, Growth, and Pubertal Development Working Group should reconsider the study on genetic determinants of obesity and the effect of environmental factors and return the study to the Gene-Environment Interactions Working Group for review. The two Working Groups should consider the study together. [Did they mean hypothesis rather than study?]
  • Conduct a conference call to resolve issues that cross across the purviews of two or more Working Groups.
  • Convene a general meeting to identify issues that require cooperative effort, and then make whatever arrangements are appropriate to work on those issues.
  • The NCSAC should identify cross-cutting issues and direct that one or more Working Groups address these issues.
  • There should be a mechanism to provide access to expert consultants.

Social Environment (Tab N)

Dr. Bachrach noted that the section was not constructed in true hypothesis form, because the Working Group felt their mission was to lay out the key elements of the social environment that are of consequence to a child’s health and development. There are six domains: family, community (schools, churches, childcare facilities), socioeconomic status, public policy, and an area not yet fully finalized, race and ethnicity. That area may be integrated into one or more of the other domains.

Dr. Yeargin-Allsopp asked whether race outcomes will be part of the Study. If so, how will these outcomes be defined? Participants agreed that this is an important issue because race is a concept that will probably change significantly over the course of the Study.

There was a brief discussion on whether a workshop on the issue would be appropriate to identify the aspects of race that might impact science. If so, attendance at the workshop should be limited to a small group (10–12 participants, including representatives of other Working Groups). The workshop could, perhaps, be chaired by a member of the Gene-Environment Interactions Working Group. Balance should be maintained, even if outside representatives are invited.

Alternatively, the issue could be assigned to the Gene-Environment Interaction Working Group since it is related more to the biology of human development (genetics) than to social issues.

Dr. Spence noted that a significant aspect is the premise that the Study population must be representative of the entire United States. Whatever is selected at the outset will see a change in racial distribution over time that will affect the longitudinal study characteristics, especially as the number of interracial families is likely to increase. The challenge will become clearer when the genes to be studied are identified (and the variability across racial lines can be determined).

Recommendations:

  • Conduct a workshop on the aspects of race that might impact the Study.
  • Consider assigning the issue of race to the Gene-Environment Interaction Working Group.

Cross-Cutting Issues

Dr. Bachach explained that the Social Environment Working Group has been considering the importance of issues related to the overall Study. The NCSAC has agreed to the Working Group’s decision to conduct a workshop to identify issues most appropriate to the Study. The Working Group feels there should be more collaboration with other Working Groups regarding some issues (such as obesity, racism hypothesis, and injury). It would be helpful to get a list of important developmental/behavioral outcomes that the Study might look at.

Recommendations:

  • Solicit input from the various Working Groups on Study outcomes, and prepare a list of key developmental/behavioral outcomes (including well-child and more serious impairments and conditions).
  • Convene a meeting to identify issues most appropriate to the Study. Include a neurologist to discuss serious developmental conditions (such as epilepsy, mental retardation, and autism).

Developmental Measures

The group discussed a paper on developmental measures being prepared by a contractor, Battelle. Dr. Scheidt indicated that the contractor had received the scope of work and was preparing a work plan (the paper should be completed by the end of the year). Topic areas include mental health, cognitive development, social/affective development, and social/emotional development.

Peter C. Scheidt, M.D., M.P.H., ICC Member, National Children’s Study Director, NICHD, NIH, DHHS, noted that the role of the Development and Behavior Working Group should be to look at how the Study can advance the science of biology of human development, which is also related to genetic susceptibility to outcomes modified by environmental exposure.

Dr. Bachrach initiated an extensive discussion about the Development and Behavior Working Group, noting that activity has been focused on the developmental side, perhaps to the detriment of the behavioral side. Some restructuring of the Working Group might be appropriate, perhaps new appointments at the co-chair level to focus on the two aspects. Dr. Yeargin-Allsopp recommended that the Working Group describe the issue to the NCSAC chair. That Working Group also should cooperate with other Working Groups in identifying neurodevelopmental conditions that should be part of the Study. This information would be useful (if specific enough) to Battelle as it develops its work plan.

Recommendations:

  • The Working Group should work with the NCSAC and Battelle as the report is prepared.
  • Interim reports from Battelle should be distributed to all Working Groups.
  • Consider restructuring the Development and Behavior Working Group to ensure appropriate attention to behavioral as well as developmental issues.
  • Request further clarification from the Development and Behavior Working Group on the major hypothesis (positive environment), which would be well-informed by making the hypothesis more specific. However, if the Working Group were reconstructed, it would probably be best to wait for the Battelle report.

Specificity

There was a brief discussion about specificity, the broad range of data routinely collected using standard instruments (for example, IQ tests), and the need to identify neurodevelopmental conditions for the Study. Barbara R. Foorman, Ph.D., NCSAC Member, University of Texas-Houston Health Science Center, noted that there are hypotheses that pertain to parental actions and behaviors, including some observational components. There are also hypotheses that deal with unique behavior groups among the children.

Recommendations:

  • Consider identifying other relevant behaviors (such as parental behaviors) that may create an environment of child endangerment).
  • Target select sub-groups from the entire sample to look at specific behaviors and/or conditions that would be relatively rare among the overall Study population.

Participant Burden

There was a brief discussion about managing the burden on the Study participants. This involves not only the time required to participate, but the experience itself (stressful, relaxing, fun, interesting).

The Sub-Group noted that there would be more flexibility in referring participants (when appropriate) to various sites, such as CPAs, Starts, and CDC sites. This would allow nearly full coverage of the United States. Dr. Spence added that the possibility of referral could be a direct benefit to a child participating in the Study.

Spanish-Language Study Component

Finally, there was a brief discussion about the importance of having a Spanish language component. Participants recognized that the Study needs to address the cultural differences among the various Hispanic communities, and variations in vocabularies and usage depending on country of origin and location within the United States.

In Attendance:

Thematic Sub-Group Members
Chair: M. Anne Spence, Ph.D., University of California, Irvine
Christine Bachrach, Ph.D., NICHD, NIH, DHHS,
Barbara R. Foorman, Ph.D., University of Texas-Houston Health Science Center
Peter C. Scheidt, M.D., M.P.H., ICC Member, Study Director, NICHD, NIH, DHHS
MarshalynYeargin-Allsopp, M.D., CDC

 

  6/1/2008
  8/31/2005