You are being asked to allow your child (who is a minor) to participate in this research study because he or she has a neurodevelopmental disorder. Children with neurological and/or developmental disorders have a higher prevalence for chronic sleep disturbances that are usually far more difficult to treat than those experienced by their ‘normally’ developing peers. Please read the following information carefully. You are free to discuss this with others if you wish. Should there be anything that unclear about this form or if you would like to have more information about that study than is currently present on this form, please feel free to bring such matters to our attention. Take time to decide whether or not you want your child to participate in this study.
What is the purpose of the study?
Several studies have suggested that sleephormone1 is beneficial for children with
developmental delay and in particular to those with visual problems. More importantly, sleephormone1 appears to be effective in both reducing the time that it takes children to fall asleep (time to sleep onset or sleep latency) as well as increasing the total duration of continuous sleep throughout the night.
Recent placebocontrolled trials have demonstrated that sleephormone1 appears to be effective in elementary (primary) school children without neuro-developmental delay or neurological disorders and idiopathic chronic sleep onset insomnia as well as in some children with epilepsy. Sleephormone1 is currently unlicensed for this clinical use (of improving sleep in children whether or not the child has neuro-developmental problems).
The Term Paper on The Connection Between Child Abuse And Dissociative Identity Disorder
The Connection between Child Abuse and Dissociative Identity Disorder I my essay I will discuss the controversial issue of Dissociative Identity Disorder and how it relates to child abuse. I will provide with the definitions of the psychological terms needed for my argumentation. They will be the following: Dissociative Identity Disorder, schizophrenia, amnesia, and fugue. Also I will argue if ...
How will we do the study?
All patients, whether or not receiving the injection will be carefully monitored throughout the trial. At the end of the trial, all information will be processed to see if the numbers of blood clots are reduced in the group of patients who received the injections compared to the group of patients who did not receive the injection. All patients in this trial will be monitored on a regular basis.
A randomized half of the patients taking part in the study will give themselves, or be given; a daily oral dose of the intervention for a maximum of 12 weeks and the other half will not receive any of these interventions. The patient can also opt for intervention administration through nasogastric/gastrostomy/jejunostomy tube.
Why have I been chosen?
We hope to enrol 172 qualified patients from all over the UK.
Does my child have to take part?
No, it is up to you to decide whether or not your child should take part. If you do decide to take part, you will be given this information sheet to keep and be asked to sign a consent form. If you do decide to take part, you are still free to withdraw your child at any time and there is no need to give a reason for withdrawal.
What will happen if I don’t want my child to carry on with the study?
You can withdraw your child from the study at any time, but signing the consent form means that you must still allow us to collect information about your child’s health. Alternatively, you can withdraw your child from the study completely.
A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care that your child will receive.
What will happen to my child if I take part?
At randomisation each patient will be allocated their own ‘individual patient package’ containing either sleephormone1 or placebo. These packages will be retained in the pharmacy department of the relevant institution and issued on a weekly basis dependent upon dose to be administered. The child will be given the first dose and kept on that dose for a minimum of seven days. For the next three weeks and at each one-week interval during this time, the child’s sleep disorder will be reviewed by the research nurse during home visits and the medication either left unchanged, increased to the next dose increment based upon the protocol dose modification criteria or decreased due to the presence of adverse events.
The Research paper on Patient Case Study
Patient case study. Part I: I would like to start by saying that AIDS is a short form for Acquired Immune Deficiency Syndrome. It is a disease that damages the body's immune system (the system that helps fight off illnesses). When a person's immune system is damaged, he or she is more likely to become sick from illnesses that might not hurt a person who has a healthy immune system. The person's ...
The decision to increase medication will be based upon the protocol dose modification criteria: (i) absence of Serious Adverse Events; (ii) a minimum of 5 of 7 days completed in the sleep diary; (iii) no significant increase in seizure activity (where applicable); (iv) child having received at least 5 of the possible 7 doses in the current week; (v) a) child not falling asleep within one hour of ‘lights off’ or ‘snuggling down to sleep’ at age-appropriate times for the child in three nights out of five, and/or b) child having less than 6 hours of continuous sleep in three nights out of five. There are a maximum of 3 dose increments after the starting dose of 0.5 mg, through 2.0mg, 6.0mg and up to a maximum of 12.0mg.
After seven days, the child will either be maintained on that dose if the sleep disorder has improved (i.e. the fifth dose modification criteria is no longer met) or increased to the next dose if all dose modification criteria are met. This process will be repeated after a further seven days until the third home visit after commencing study drug. If doses are increased at each home visit, the maximum dose threshold will be achieved by T+3W and for the remainder of the study, the child will remain on the dose achieved by the fourth week of treatment unless a reduction is indicated when reviewed at subsequent follow-up. For children who have not achieved the maximum dose level in week T+3W, a dose increment at T+4W may also be considered. Dose increases in weeks T+5/T+6W are permitted with appropriate clinical review but are not permitted beyond this time.
What are the Potential Risks and Benefits
Clinical studies in humans (adult volunteers and patients of both sexes and all ages) have not shown any consistent or serious short or long-term adverse side-effects.
The Research paper on Child study case
This case study is on a young girl named Jacqueline. She was observed in a classroom at the Early Learning Center. She is 4 years old. She is the only child, and lives with her father and grandmother. Throughout the paper, it compares Jacqueline’s development to what develop mentalist say is normal. The paper is focused primarily on cognitive, physical, and social developments. The paper gives ...
Very few meta-analyses of randomised controlled trials (RCT) exist. Those that have been undertaken indicate that exogenous sleep hormone may improve sleep with reported benefits including a reduced sleep latency time (i.e.: reduced time to fall asleep), reduced number of awakenings throughout the night (i.e.: increased periods of continuous, un-interrupted sleep throughout the night) and improved behaviour and performance during the day.
What does my child have to do?
Your child will be given a series of intervention through a definite time period.
Your child will need to agree to complete the questionnaires and be observed by the researchers.
What is Sleephormonel?
Sleephormone1 is an oral capsules, containing sleep hormone, lactose, and magnesium stearate in a size 2 white opaque, gelatine capsule. The fill weight of each capsule is 200mg. The gelatine is of animal origin.
What if I choose not to let my child take part?
There is no penalty upon you or your child if you do not let your child take part of this study.
What if new information becomes available?
Sometimes during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, your child’s doctor will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw your child, your doctor will make arrangements for your child’s normal care to continue. If you decide to let your child continue in the study you will be asked to sign an updated consent form.
Also, on receiving new information, your doctor might consider it to be in your child’s best interests to withdraw you from the study. He/she will explain the reasons and arrange for your child’s care to continue.
What happens when the research study stops?
After the 24 week period, your child’s care will continue as normal under the guidance of your child’s doctor.
What if something goes wrong?
Child Marriage Research Paper
Child Marriage: Why is the Act Performed Throughout Countries Around the World? According to the International Center for Research on Women, “if present child marriage trends continue, more than 142 million girls worldwide will be forced to marry adult men during the next decade-the equivalent of 38,000 girls every day.” Child marriage is defined as marriage before the age of eighteen ( ...
If your child is harmed by taking part in this research project, there are no special compensation arrangements. If your child is harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way your child has been approached or treated during the course of this study, the normal National Health Service complaints mechanisms are available to you.
Will my child’s part in the study be confidential?
Individual participant medical information obtained as a result of this study is considered confidential and disclosure to third parties is prohibited with the exceptions noted below.
Electronic and paper CRFs will be labelled with patient initials and unique trial registration and/or randomisation number prior to transfer to the data coordinating centre. Medical information may be given to the participant’s medical team and all appropriate medical personnel responsible for the participant’s welfare. Verification of appropriate informed consent is enabled by the provision of copies of participants’ signed informed consent/assent forms being supplied to the data coordinating centre by recruiting centres. This requires that name data will be transferred to the data coordinating centre. The data coordinating centre will preserve the confidentiality of participants taking part in the study.
What will happen to the results of the research study?
The results of this study will be shown at research meetings and submitted to major research journals for publication. You will not be identified in any way in any report or publication arising from the study. If you would like to be told about the results at the end of the study please feel free to ask your doctor.
