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National Children's Study Receives Funding to Expand Study and Begin Recruitment
In February, the National Children's Study received an appropriation of $69 million from Congress to support expansion of the Study into additional communities across the country. This step signals a new Study milestone, with the posting of a Request for Proposals (RFP) to fund 15-20 new Study Centers nationwide. With this funding, the already established Study Centers (called Vanguard Centers) will now be able to begin recruitment.
"We are delighted about this next step in the Study's progress," said National Children's Study Director Peter Scheidt, M.D., M.P.H. "We can now begin the true work of the Study, working with families and communities to find out the root causes of what makes children sick and what keeps them healthy. This is a giant step forward for our children," he said.
An announcement about the Study's funding status was made on February 16, 2007.
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National Children's Study: Progress in 2006 and the Promise of 2007
The National Children's Study made several gains in 2006, including progress in the Vanguard Centers and Coordinating Center activities, Study Protocol development, and ongoing meetings of the National Children's Study Steering Committee. With scientific planning near completion and the recent funding appropriation, 2007 promises to bring the Study a major step closer to full Study implementation.
 Throughout 2006, Vanguard Center leaders were active in their Study locations, meeting with local community groups and health care professionals to inform them about the Study, and forming Community Advisory Boards (CABs). CABs are composed of representatives from the local community who will provide ongoing guidance on a range of Study-related issues, such as sampling (how best to divide up neighborhoods and residences for recruiting families, if necessary), effective recruitment techniques, appropriate incentives for participants, and ways to share Study information with participants.
Vanguard Center Study teams have also been busy conducting needs assessments in their communities. By analyzing local health data and meeting with community members, the teams can obtain an overall picture of the current child health concerns and begin to anticipate the community's response to the Study's presence in their communities.
Vanguard Center activities also vary according to community needs. For example, in preparation for sampling neighborhoods in the rural Study location of Brookings county, SD and Yellow Medicine, Pipestone, and Lincoln counties, MN, Principal Investigator Bonny Specker and her Vanguard Center team are conducting a pilot study to determine the most accurate ways to identify housing units in these counties.
The Salt Lake County Vanguard Center team is carrying out pilot studies on measurement tools and developing programs to hire and train bilingual research assistants. Ideas for adjunct studies are also under consideration. "Excitement about the National Children's Study has stimulated children's health professionals to think boldly about new ways to address children's health problems," said Edward Clark, M.D., Principal Investigator at the University of Utah. "2006 was a year of excitement, anticipation, and hard work," he said.
Moving forward, Vanguard Centers will continue community outreach and other activities such as establishing the infrastructure necessary to enroll participants and manage data. Specialized teams covering topics such as biospecimen collection and outreach and engagement have been meeting regularly in preparation for full Study implementation.
With Vanguard Centers at work on the local level, the National Children's Study Coordinating Center has been busy making preparations to help support the implementation and management of all Study Centers once the Study is launched. This year the Coordinating Center will continue to work to refine the Study Protocol, data collection instruments and procedures, and requirements for the information management system.
Research Plan and Study Protocol
National Children's Study scientists are heavily engaged in finalizing the science behind the Study. The various stages of implementation necessitate different approaches and levels of detail that require unique protocol documents. Moving from the Study Plan, first presented in 2004, scientists are finalizing what they are calling the Research Plan. This document builds on the initial Study Plan, and describes the scientific background, rationale, and design of the National Children's Study. The Research Plan provides an overview of how researchers will conduct the Study and the data that will be collected. The final Research Plan will be made available for peer review by an outside panel of scientific experts in early 2007.
The Study Protocol is also nearing completion. The Protocol will include specific measures from preconception through 18 months of age, with less emphasis on the background rationale for the Study and Study hypotheses. Subsequent versions of the Protocol will be developed approximately two years prior to planned data collections. For example, specifications of measures for a visit with a three year old will be complete by the time the child is one. This approach allows incorporation of the most up-to-date measurement tools as well as the flexibility to address the most pressing scientific issues.
Program Office, Vanguard Center, and Coordinating Center staff have all been involved in the development of the Research Plan and Study Protocol.
Steering Committee
The National Children's Study Steering Committee met quarterly in 2006 to discuss key Study issues, including the process for obtaining informed consent from participants, community engagement strategies, the schedule of Study visits--how often participants will be visited or will visit Study Centers--and methods to minimize the burden of data collection during these visits.
In March 2006, two new positions were created on the Steering Committee to ensure representation of community and Study participant interests. These positions are rotating and will remain a priority on the Committee as the Study continues. The Steering Committee is also made up of Principal Investigators from the Vanguard Centers and Coordinating Center, and representatives from the Interagency Coordinating Committee and Program Office. The Steering Committee will next meet in May of 2007.
Moving Forward
With the recent posting of an RFP (PDF 25 KB) for new Study Centers, the National Children's Study will soon be busy reviewing applications from university hospitals, health departments, and other institutions.
"We have spent over five years planning for this moment," said Dr. Scheidt. "With the new funding, we are now on the brink of launching a study unparalleled in its potential for helping improve children's health," he said.
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Bonny Specker, Ph.D.
 Dr. Bonny Specker, an epidemiologist who has worked in pediatrics most of her career, is leading the Vanguard Center in Brookings County, SD, and Yellow Medicine, Pipestone, and Lincoln Counties, MN. This Vanguard Center represents a collaboration between South Dakota State University (SDSU), the Cincinnati Children's Hospital Medical Center, and the University of Cincinnati's Department of Environmental Health. SDSU will also collaborate with the Sioux Valley and Avera Health Systems, as well as other local hospitals and clinics.
"Working with the University of Cincinnati and Cincinnati Children's Hospital Medical Center is an obvious connection because of their terrific pediatric environmental health expertise and our past collaborative work," said Dr. Specker. "At SDSU we've combined talent from our human development, nursing, rural sociology, environmental engineering, and exercise physiology departments, as well as expertise from our Geographical Information Sciences Center of Excellence."
Since designation as a Vanguard Center, the Vanguard Center staff conduct monthly conference calls to discuss planning activities and last summer held the 1st Annual Children's Environmental Health Seminar at SDSU, which discussed Study-related topics such as the impact of environmental toxicants on children's cognition and behavior and risk factors for fractures and injuries among children, to raise the profile of children's environmental health within the community.
A unique aspect of the Vanguard Center is its access to the USDA-funded Cooperative Extension System, whose mission is to help people improve their lives through an educational process that uses unbiased, science-based knowledge focused on rural issues and needs. It is a network of regional offices anchored by SDSU's status as a land-grant university.
Children in rural communities are more likely to die young and are hospitalized more often than their urban peers, according to a recent report from the Washington State Department of Health, and the overall child hospitalization and death rate is significantly higher in rural areas. According to Dr. Specker, many factors make up the higher rate, including motor vehicle accidents, poverty, inadequate number of pediatric providers, and a lack of transportation for many rural residents. However, the percentage of low birth weight babies in this Vanguard community is one of the lowest among the Vanguard Centers at 5.9 percent. The Study community is 96 percent Caucasian, with one Native American reservation.
The Vanguard Center will face a significant challenge associated with studying rural communities: finding and recruiting Study participants. For example, the four South Dakota and Minnesota counties cover more than 2,500 square miles, and Vanguard Center staff are expected to recruit 75 to 80 percent of the counties' newborns. To reach this goal, the Vanguard Center is developing innovative strategies to reach their Study recruitment population.
"We are pilot testing two ways to identify housing units in rural locations to see if these methods are accurate and more cost-effective than the traditional method. The first method uses satellite imaging to locate houses, and the second utilizes plat maps [maps of a town or subdivision which indicate the boundaries of individual properties] from zoning offices. These methods will be compared with the traditional method of listing housing units, which involves physically driving on every road. In terms of accuracy, the traditional method is most conclusive, but it's not always feasible in rural communities," she said.
Dr. Specker believes the results will benefit any national survey, including the National Children's Study, that requires identifying housing units, or homes, within rural communities.
According to Dr. Specker, the citizens of South Dakota and Minnesota are well known for their willingness to participate in studies. "The local communities involved in the Study will play a significant role in helping to form partnerships within the counties," said Dr. Specker.
Community engagement activities by the Vanguard Center have included presentations to Rotary and Kiwanis clubs, and interviews on the radio program "Holm Spun Medicine" and television shows such as "Ag Today" and "On Call."
Dr. Specker is also conducting a longitudinal study about whether lifestyle factors can influence peak bone mass among South Dakota's rural populations. Dr. Specker is particularly interested in what the National Children's Study will uncover about factors that influence bone development and growth in childhood across various populations.
Earning her Ph.D. in Epidemiology from the University of Cincinnati, Dr. Specker completed her dissertation on factors influencing Vitamin D status in breastfed infants. Prior to moving to South Dakota, Dr. Specker was Professor of Pediatrics at Cincinnati Children's Hospital Medical Center and was involved in pediatric nutrition and bone research. Dr. Specker currently holds the Ethel Austin Martin Endowed Chair at SDSU, which provides funding for multidisciplinary research and education related to human nutrition.
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Antidepressants and Suicide Among Adolescents and Young Adults
According to the CDC, suicide is the third leading cause of death among adolescents ages 15 to 24. 1However, there is currently a controversy concerning the appropriateness of administering anti-depressant medications to children and adolescents. An estimated 1.4 million children and adolescents ages 18 and younger received antidepressant medication in 2002, according to data available from the U.S. Agency for Healthcare Research and Quality. 2
Since 2004, the Food and Drug Administration (FDA) has required all antidepressant labels to carry a "black-box" warning about the risk of suicidal thinking and behavior among children and adolescents. However, a federal advisory panel recently concluded that the warning should be extended to patients older than 18, based on an extensive clinical trial analysis, which found that antidepressants double the risk of suicidal behavior in young adults from about three cases per thousand to seven cases per thousand. 3
The panel encouraged the FDA to alert physicians and the public to the risk, while also noting that the risk declines with age and that leaving depression untreated also can be hazardous.
The recommendation coincides with a long-running debate over the safety of antidepressant medications. Some psychiatrists argue that expanded warnings could facilitate an increase in suicides by causing a black-box panic, while others say that the labeling could prompt physicians to be more cautious about prescribing the drugs, limiting them to patients who are seriously depressed. Since the FDA recommended the black-box warning for minors, there has been a decreased rate of antidepressant prescriptions for children and adolescents in the United States and other countries, 4although there is clear evidence for a positive effect in many children.
Recent findings from the National Institute of Mental Health funded Treatment for Adolescents with Depression Study suggest that the combination of fluoxetine and cognitive behavioral therapy achieves greater recovery than either alone. That combination treatment may offer a more favorable safety profile than medication alone, which was associated with a significant increase in suicide-related events. 5
By evaluating the effects of environmental influences on the health and development of more than 100,000 children across the United States--from birth to age 21--the National Children's Study will build a repository of information that scientists can use to explore and address the questions surrounding the use of antidepressants and suicide among adolescents and young adults. Study researchers will look at how a child's genes interact with certain psychosocial exposures, such as family and community influences, and other exposures, to impact his or her mental health and development. This research may help identify the causes of depression among this population and the treatment modalities that are proven to be the most safe and effective.
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1 Anderson, R.N., Smith, B.L. (2003). Deaths: leading causes for 2001. National Vital Statistics Report 2003, 52(9), 1-86.
2 Vitiello, B. Zuvekas, S.H., Norquist, G.S. (2006). National estimates of antidepressant medication use among U.S. children 1997-2002. Journal of the American Academy of Child & Adolescent Psychiatry, 45(3), 271-279.
3 Vedantam, S. (December 14, 2006). Antidepressants a suicide risk for young adults. The Washington Post, A16.
4Rosack, J. (2004). SSRI prescriptions to youth on decline since February. Psychiatric News, 39, 9.
5March, J., Silva, S., Vitiello, B. (2006). The treatment for adolescents with depression study (TADS): methods and message at 12 weeks. Journal of the American Academy of Child & Adolescent Psychiatry, 45(12), 1393-1403.
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