How the National Children's Study Works: Federal Collaboration (January 2008)

IN THIS ISSUE: Feature - How the National Children's Study Works: Federal Collaboration New Study Center Announcements - Reaching Local and Multicultural Communities through Media Principal Investigator Profile - Maureen Durkin, Ph.D., Dr.P.H. Good to Know - New Pediatric Guidelines Released for Autism Detection, Evaluation, and Management

Feature

How the National Children's Study Works: Federal Collaboration

The National Children's Study lead agency partners--the National Institute of Child Health and Human Development (NICHD), the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), and the National Institute of Environmental Health Sciences (NIEHS)--are no strangers to collaboration. Whether providing laboratory support or serving on advisory boards, each agency has contributed in some way to other federal child health research. "But the National Children's Study is so large in size and scope that it represents an opportunity and need for an unprecedented level of planning and interagency collaboration," said Sheila Newton, M.S., Ph.D., Director, Office of Policy, Planning, and Evaluation, NIEHS.

Featured: ICC members Kenneth Schoendorf, M.D., M.P.H., Scientist, and Amy Branum, M.S.P.H., Health Statistician, of the National Center for Health Statistics, CDC

Interagency Coordinating Committee Leadership

The Interagency Coordinating Committee (ICC) represents the Study's main response to this need for collaboration. The ICC is the oversight body, which monitors all aspects of the Study--ranging from ways to gather participant data to how best to protect participant privacy. Its twelve representatives assure that at a high level, the mission and goals of the National Children's Study are maintained over time and that they reflect the scientific priorities of the Study's four lead agencies.

Interagency collaboration has guided the Study since its beginning. In 1997, the Task Force on Environmental Health Risks and Safety Risks to Children was established by Executive Order to further federal collaboration toward child health protection.

The Developmental Disorders Working Group of the Task Force--comprised of representatives from the NICHD, EPA, CDC, NIEHS, and other agencies--proposed a longitudinal cohort study that could fill the current research gaps concerning the relationship between the environment and child health. The Task Force accepted this proposal and the National Children's Study was conceived. By the time the Children's Health Act of 2000 authorized "a consortium of representatives from appropriate federal agencies" to lead a study of this nature, the Study's decision-making body was nearly in place. When NICHD established the Study's formal organizational structure, these agencies began meeting in an official capacity, as the ICC.

"The ICC represents a new paradigm, a new way of working together," said Marshalyn Yeargin-Allsopp, M.D., Medical Epidemiologist and Branch Chief, Developmental Disabilities Branch, Division of Birth Defects and Developmental Disabilities, CDC, and ICC member. "Sometimes the power rests with just one agency. In the case of the National Children's Study, the contributions of all the lead agencies are seen as equally important. The spirit of collaboration is definitely there."

Liz Blackburn, R.N., B.S.N., who chairs the ICC, points out that the Committee's differing viewpoints make the science better. "We have had to make some challenging decisions about the direction of the Study," said Ms. Blackburn, Coordinator of Community Affairs and Outreach at EPA's Office of Children's Health Protection and Environmental Education. "For example, to decide what types of information to collect and what is reasonable to ask of participants, without causing undue burden."

"To make these decisions, we give everyone a chance to weigh in. If there are differences of opinion, it is usually due to our varied scientific disciplines--we have pediatricians, epidemiologists, exposure and public health scientists, and policy and community outreach experts. Sometimes we need expert counsel from others to help us make the most informed decision," said Ms. Blackburn.

Each agency brings a unique perspective to the Study. With its mission rooted in child health and well being, the NICHD leads the other agencies with oversight from NICHD Director Duane Alexander, M.D. The CDC lends large-scale data collection, state-of-the-art laboratories, and community networks, while EPA brings its experience in the assessment of environmental health exposures and connections at the local level through its regional presence. NIEHS has extensive expertise examining the environmental underpinnings of human disease and how very early exposure to environmental agents can translate into disease and dysfunction later in life.

"The lead agencies bring visibility, intellectual capital, and community networks to the Study, which one agency alone could not provide," said Yvonne Maddox, Ph.D., Deputy Director of the NICHD.

Members of the ICC recently engaged their respective agencies in a review of the Research Plan--a detailed document that describes the need for the Study and how it will be carried out--and is currently deciding how to address major Study components such as adjunct studies and the timeline for reporting Study findings. ICC oversight helps ensure that data generated by the National Children's Study is relevant to government agencies who issue policies related to child health and development.

Additional Federal Agency Input

In addition to the ICC, the Federal Consortium also provides guidance to the Study. This forum, which includes representatives from multiple federal agencies, meets as needed and at the discretion of the ICC and Program Office, as part of the comprehensive Study review process. The Federal Consortium will continue to inform federal agencies about the Study's progress and to seek their input, especially as findings from the Study emerge which may impact the activities of federal agencies such as the Indian Health Service and its child health policies and programs, among other agencies.

Investigators from various sectors, including government, will also be encouraged to submit proposals to use National Children's Study data for the conduct of adjunct studies. "The Study will yield rich datasets that provide an opportunity for interagency collaboration beyond the parameters of the National Children's Study. With these data, researchers can conduct adjunct studies that will answer all sorts of questions we haven't even considered," said Dr. Maddox.

By evaluating how environmental exposures before birth and in childhood impact both child and adult health, the National Children's Study will seek answers about the root causes of many health conditions--such as obesity, asthma, and autism--which various federal agencies aim to redress. Input from these agencies and collaboration from the Study lead agencies will help ensure the best research, hopefully leading to better policies and health programs for all U.S. children.

back to top

New Study Center Announcements: Reaching Local and Multicultural Communities through Media

On October 4, the National Children's Study Program Office teamed with new Study Center staff to help announce the funding of 22 new centers in 26 Study locations. By reaching out to their local media, new Study Centers garnered media attention across the country, including major media outlets in Boston, Chicago, Detroit, St. Louis, Los Angeles, as well as smaller outlets in Texas, Minnesota and other states. Engaging newspapers, television, and radio about the Study will help generate public awareness, a critical step in preparing for recruitment. To reach additional African-American communities, Study leaders conducted 13 radio interviews at the national and local levels. Hispanic audiences were also targeted through outreach to small and large publications like Hoy, CNN en Espanol, and La Prensa (MN), resulting in a total of 79 stories overall.

back to top

Principal Investigator Profile

Maureen Durkin, Ph.D., Dr.P.H.

Dr. Maureen Durkin, Ph.D., Dr.P.H., Epidemiologist and Associate Professor of Population Health Sciences and Pediatrics at the University of Wisconsin-Madison, has spent most of her career developing methods for and investigating the epidemiology of childhood neurological disorders and injuries. She has also directed international studies of the prevalence and causes of neurodevelopmental disabilities in low income countries.

As a member of the Centers for Disease Control and Prevention's Autism and Developmental Disabilities Monitoring Network, Dr. Durkin is working to help develop U.S. population-based estimates of the prevalence of Autism Spectrum Disorder (ASD), cerebral palsy, and related disorders.

"In recent years, we have seen an increase in the number of children identified as having autism in the state of Wisconsin, nationally, and even globally," said Dr. Durkin. "This has led to concerns about whether we are facing an epidemic. Everything we've seen in the descriptive epidemiological research suggests that environmental exposures, genetics, and gene-environment interactions are contributing factors."

In September 2005, Dr. Durkin became Principal Investigator of the National Children's Study Vanguard Center for Waukesha County, Wisconsin, along with Co-Principal Investigator Chris Cronk, Ph.D., from the Medical College of Wisconsin. "With the National Children's Study, we will be able to study how gene and environmental factors interact over time to influence the development of these neurological disorders and other conditions," said Dr. Durkin.

Environmental factors include the make-up of a child's physical environment, such as exposures in soil and water. In Waukesha County, Dr. Durkin and her team will examine how rapidly changing land use patterns have impacted the environments where children live and grow.

"Waukesha is largely rural but is becoming more developed, with many of the dairy farms and other agricultural areas of the county rapidly converting into suburbs. What was a corn field yesterday is a subdivision tomorrow," she said. "These changes are happening extremely fast." No one currently knows whether there are any long-term health effects from exposure to the residual agricultural chemicals in the soil.

The Waukesha Study team will also look at health effects related to drinking water supplies. Most of the county gets its drinking water from groundwater sources containing relatively high levels of radium that leach from bedrock in the area. The groundwater is also contaminated from the use of agricultural chemicals, such as pesticides and fertilizers. Other parts of the county obtain water from nearby Lake Michigan. By comparing these two sections of the county, the National Children's Study will investigate the impact of ground and surface water contaminants on health outcomes.

In addition to studying factors in the physical environment, Study researchers will examine the population of Waukesha County to make county- and state-wide comparisons as well as comparisons with other Study locations. Waukesha County differs from most other Study locations--and from much of the country--in its relative affluence. Nearly 96 percent of children in Waukesha County have health insurance, compared to 88 percent nationally. Most children in the county also enjoy the benefits of early prenatal care. For example, in 93 percent of births in 2006, women had received prenatal care during their first trimester. This percentage is higher than any other county in Wisconsin and among the highest in the nation. Mothers in Waukesha County tend to be older and more highly educated at the time of delivery than the national average, with 23 percent of births in the county to women aged 35 or over, and 54 percent of mothers having a bachelor's degree or higher. The Waukesha County site provides the opportunity to examine what differences these factors make to perinatal and other outcomes when compared with other Study locations.

The Waukesha County Vanguard Center is a collaboration between the University of Wisconsin-Madison, the Medical College of Wisconsin, the National Opinion Research Center, and Marquette University.

"The Study is an unprecedented opportunity to investigate the impact of prenatal environmental factors on human reproduction and children's health and development," said Dr. Durkin. "We are extremely excited to be part of this effort."

back to top

Good to Know

New Pediatric Guidelines Released for Autism Detection, Evaluation, and Management

The American Academy of Pediatrics (AAP) recently published new surveillance and screening recommendations to help pediatricians recognize Autism Spectrum Disorders (ASDs) earlier and initiate interventions that could help improve the lives of children affected by ASDs and their families. The guidelines were developed in response to new research showing that ASDs sometimes can be diagnosed with reasonable reliability as early as 18 months of age.

Language delays--usually around 18 months of age--typically prompt parents to consult with their child's pediatrician. However, if detected, a series of other subtle signs could also lead to an earlier ASD diagnosis. These include:

Surveillance--The AAP recommends developmental surveillance at every well-child visit. This is an opportunity to identify "red flags" for ASDs.

Screening--The AAP recommends ASD screening of all children at 18 and 24 months of age, regardless of whether parents have expressed any concerns. However, an immediate evaluation is warranted if one or more of the following "red flags," are identified:

The AAP strongly recommends beginning intervention as soon as an ASD diagnosis is suspected, instead of waiting until a diagnosis is confirmed. The family should be referred for early intervention/preschool special education services (depending on the age of the child) at the same time that a referral is made for a more comprehensive diagnostic evaluation.³ The AAP describes how the most effective interventions for children with ASDs are programs which serve to facilitate development, encourage socialization, reduce maladaptive behaviors, and support and educate families.⁴

In addition, the AAP encourages pediatricians to become familiar with the various complementary and alternative medicine (CAM) therapies that parents often initiate; to ask families about current and past CAM use; and to provide balanced information and guidance about treatment options, while identifying potential risks or harmful effects. Researchers note that although some CAM treatments--such as the casein/gluten-free diet--are popular, there is very little scientific evidence to support or refute them.⁵ Greater research is needed to fully assess their efficacy.

With respect to size, scope, and longitudinal design, the National Children's Study will provide researchers with an opportunity to evaluate the interaction of environmental and genetic influences on children with ASDs. Data from the National Children's Study may ultimately assist the scientific and medical communities in understanding more about ASDs. Such findings will help assess the effectiveness of the AAP guidelines and other ASD screening, diagnostic, and treatment recommendations that have been issued by organizations, such as the American Academy of Neurology and Child Neurology Society, the American Association of Childhood and Adolescent Psychiatry, and the Autism Society of America, among others. The National Children's Study data may also help inform the development of other guidelines relevant to the diagnosis, treatment, and management of ASDs.

back to top

¹ Johnson, C.P., Myers, S.M., The Council on Children with Disabilities. (November 5, 2007). Identification and evaluation of children with autism spectrum disorders. Pediatrics, 120(5): 1183-1215.
² Ibid.
³ Ibid
⁴ Myers, S.M., Johnson, C.P., The Council on Children with Disabilities. (November 5, 2007). Management of children with autism spectrum disorders. Pediatrics, 120(5):1162-1182.
⁵ Ibid

back to top

Comments or Questions

E-mail us if you have questions or comments
Visit our Web site at http://nationalchildrensstudy.gov/

The National Children's Study is led by a consortium of federal agency partners:

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY