Health research proposal
?Introduction Autism Spectrum Disorders (ASD’s) are disabilities that affect social and communication skills, and cause behavioural changes (CDC, 2012). There are three types of ASD’s; Asperger Syndrome, Pervasive Developmental Disorder, and Autistic disorder (autism). Autistic disorder will be the focus of this study (CDC, 2012). Children develop autism before the age of three years and struggle with it throughout their lives (CDC, 2012). Autism creates many challenges in the child’s life and it negatively impacts; intellectual disabilities, language delays, social and communication difficulties and unexpected behaviour and interests” (CDC, 2012). Autism does not segregate between racial and ethnic groups, nor does it relate to socioeconomic status; however it has been proven to occur more often in males than in females (CDC, 2012). Over the past decade there has been a significant increase in the number of autistic diagnoses (CDC, 2012).
Evidence has shown that the development of autism occurs during the pregnancy phase (Schmidt, 2011); which leads this study to analyze the association between intake of iron, and zinc during pregnancy and preventing autism in the offspring. Specific Aims The proposed study will be focused on whether women who take iron and zinc supplements during the three trimesters of the pregnancy will reduce the risk of autism in their offspring. The goal of this study is to develop an association between vitamin exposures and the outcome of prevented risk of autism.
The proposal can potentially establish correlations that will help identify, and prevent risk factors of autism. Two objectives for this study are: to measure the prevalence of autism among young children in Canada, and to compare the levels of exposure and disease among three different cities in Canada. Background: There have been different studies conducted to explore the significant role of pre-natal vitamins, specifically folate, in neurodevelopment in the fetuses. The Environmental Health Sciences organization conducted a case-control study in California.
The controls were mothers of children without autism, and were matched to the cases based on age, sex, and place of residence in California (Schmidt R. J. et al, 2011). Mothers of children aged between 2 and 5 years were asked about their use of multivitamins and prenatal vitamins; specifically during the pre-conception period and during the first trimester of their pregnancy. Samples of DNA were taken from the mothers and their children allowing the researches to examine the genes that are responsible for carbon one metabolism (Schmidt R. J. t al, 2011); which is responsible for the processing of folate in the body. If mothers did not take prenatal vitamins and had genes that did not process folate properly, then they were at an increased risk of having an autistic child (Schmidt R. J. et al, 2011). This study has found that taking prenatal vitamins earlier in the pregnancy reduces the risk of autism. However, there has not been a difference in the risk of autism when multivitamins were used. Researchers encourage mother to take prenatal vitamins 3 months before conception and throughout their pregnancy (Schmidt R.
J. et al, 2011). The Simons Foundation Autism Research Initiative (SFARI) did clinical research analyzing the relationship between prenatal vitamins, fortified cereals and the reduced risk of autism. They asked mothers of autistic children whether they took prenatal vitamins before and during their pregnancy. The results showed that women with one of three genetic variants, who did not take prenatal vitamins, were five times more at risk of having an autistic child. However, there was no correlation between fortified cereal consumption and the reduced risk of autism.
Science Daily studied women who took folic acid and vitamin B-9 during the first month of their pregnancy, and whether it reduced the risk of having an autistic child. Researchers observed the amount and frequency of folic acid intake among mothers’. Researchers studied 835 women and measured their folic acid intake during the first month of their pregnancy (Tancredi, 2012). The study found a correlation between the amount of folic acid consumed and the reduced risk of autism in the offspring (Schmidt R. J. et al, 2011). The above studies have mainly focused on the importance of folic acid in neurodevelopment of fetuses.
However, there has not been adequate research on what other vitamins in prenatal vitamins have an effect on reducing the risk of autistic offspring. Also, almost all the studies have been conducted in California. The studies should be performed in other locations to further support the findings (Schmidt R. J. et al, 2011). Although, methods to prevent risk autism have been discovered, the biological cause of autism has yet to be found. The limitation of some of these studies is the dependence on the women’s memory of taking prenatal vitamins, when a case-control study was performed.
They research completed by SFARI had a small study population, which suggests that the study should be replicated in order to confirm the results found. This study will give mothers a wider range of vitamins to consume in trying to protect their offspring from being afflicted with autism. It will support previous research that explored the benefit of prenatal vitamins in reducing the risk of autism. This proposed study will provide a wider demographic outside of California, possibly increasing knowledge on the prevention of autism. Methodology Study Design
This proposal will follow a primary study, specifically a case-control study; it will focus on whether the cases, mothers of children with autism, and the controls-mothers of children without autism, have different exposure histories with zinc and iron. The cases are mothers of children between 2 to 6 years of age with autism. A mother will be considered a case if their child suffers from communication challenges, intellectual disabilities, and persistently wanting to be alone (CDC, 2012). The only significant difference between the cases and controls is the disease status.
Frequency matching will be applied for two variables, sex and age, to improve comparisons between the cases and controls. Study Population The study population will consist of children between 2 and 6 years of age. The population will be recruited in Toronto, Montreal, and Calgary. Based on the study of Schmidt R. J. et al, the study population will be a total of 240 mothers; this include the cases who are 120 mothers with autistic children and the controls who are 120 mothers children without autism. Furthermore, 40 children from each city will be (Schmidt R. J. et al, 2011).
Recruiting people will be done through posting posters in pediatric offices, sending invitations to parents with young children, and providing incentives. Autism Centres will be used to mainly find participants, such as; the Autism Ontario centre in Toronto, the Montreal Autism Centre in Montreal, and A Society for Treatment of Autism in Calgary. Inclusion criteria for the sample population will be mothers of male and female children between the ages of 2 and 6 years. Exclusion factors will be children not within the specific age group, children with a family history of autism, and mothers of children with co-morbidities.
Study Measurements By implementing the case-control method we know that the outcome is autism in the offspring of mother. This proposal will explore the exposure of zinc and iron in women three months prior to conception and throughout their pregnancy. The study will be measuring if zinc and iron supplements taken during pregnancy will reduce the risk of autism in the offspring. Confounding variables are external factors that affect the outcome of a study, and are different among the participants.
Family history can be a potential confounder because research shows that if a mother has a child with autism the risk of the second child having autism increases (Ozonoff, 2011). Based on the study done by Frontiers in developmental psychology, prenatal maternal stress is associated with autism in the offspring (Ronald et al, 2011). Stress can be considered a confounder because it differs among all the mothers in the cases, and therefore it can affect the association between autism and prenatal supplements of zinc and iron.
Measurement Collection Methods During the first phase of the study mothers of autistic children will be mailed autism screening questionnaires (Smeeth, 2001). The questionnaire will include sociodemographics (education level, income), family health history, personal health history, and lifestyle factors (alcohol consumption) (Jacobsen, 2012). Participants will be given the option of having phone interviews, or face to face interviews. Both methods are effective, the participant’s convenience will determine which method they prefer.
Participants will be followed for 2 years, and they will be scheduled for interviews every 3 months. They will be asked about their use of zinc and iron supplements before conception and during their pregnancy. How often they took the supplements (i. e. daily basis), and the amount of iron and zinc that was in the supplements (i. e. dose). Statistical Analyses The proposed case-control study will use an odds ratio to examine the measure of association between the cases and controls. An odds ratio compares the odds of exposure in cases and the odds of exposure in controls (Jacobsen, 59).
This method of statistical analyses implies whether the exposure was risky or protective, depending respectively on whether the odds ratio is greater than 1 or less than1. If however, the odds ratio is 1 this implies that there is no association between the exposure and outcome (Jacobsen61). Odds ratio is the most appropriate measurement for this study because it measures whether there is an association between the reduced risk of autism, and the consumption of zinc and iron supplements during pregnancies.
Other statistical tests such as incidence and risk ratios examine the incidence of new disease, which does not relate to goal of case-control studies (Jacobsen, 70). Ethical Issues There are four principles in research ethics, they are; beneficence this describes that the study should “do good”; nonmaleficence which reduces any type of potential harm to the participant (i. e. psychological harm); autonomy which entails voluntary participants in the study; justice describes the benefits and risks of a study as socially just (Jacobsen, 2012).
The main ethical issue for this proposal is confidentiality, since the outcome of disease is already present. Participants will be numbered during the study, and therefore the names of parents and children will not be revealed. Also, at any time during the study participants can freely choose to leave the study (York, 2012). All human participants who willingly volunteer to be examined in this study will be fully informed of the research objectives, procedures, and potential benefits. Risks, benefits, informed consent, privacy and confidentiality of the participants will all be considered during the procedure of the study (Jacobsen, 2012).
Study Limitations Although case-control studies have many benefits there are a few limitations that exist. Case-control study designs can only analyze and measure one outcome. Case-control studies are most affected by bias which can be identified as an interpretation of results that do not represent the whole truth (Pietrangeli, 2012). Four main types of bias exist; selection bias indicating the population of interest is not clearly represented; measurement bias indicating errors in the outcome of interest (Pietrangeli, 2012). intervention bias describes the relationship between an exposure and an unassigned treatment; recall bias which is specific to case-control studies results from inaccuracies in reporting the past (Pietrangeli, 2012). Recall bias applies to this study because mothers are going to be asked about their past use of certain vitamin supplements. Therefore mothers in case and control groups may have inconsistent memories of their past. However, there are methods to reducing bias. To control selection bias, the study should have specific exclusion factors.
Matching can be used to reduce measurement bias; however in case-control studies the effect of a matched variable cannot be analyzed. Intervention bias can be better controlled through stratification of randomized controlled trials. A multivariate treatment of data can reduce recall bias (Pietrangeli, 2012). The duration of this study is 2 years, and following up with the participants may prove to be challenging. Limitations within the population exist because some participants may choose to leave during the study, and some may move away from their homes.
The limitation of the study measurement is the reliance upon participant recall. There is no way to prove that participants are remembering their past accurately, and mentioning significant details. Since case-control studies are conducted knowing the outcome, there are not many ethical issues, except for confidentiality of participants’ identities and information. Medical and Social Importance The results of the proposed study will provide additional methods in preventing autism in mothers’ offspring.
Results will indicate whether zinc and iron have an effect on the neurodevelopment of developing fetuses, early in the pregnancy. Mothers will have a broader range of vitamins and minerals to implement into their diets for the benefits for their children. Community health programs and worldwide organizations such as WHO, are attempting to find the cause and a cure of Autism Spectrum Disorders. Perhaps future research can focus on a prospective cohort study, then compare the results to case-control studies to determine how accuracy of participants’ recall history.
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