Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766580
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2021-02-17
Brief Title:
Attention and Pain in Children With and Without Attention Deficit andor Hyperactivity Disorder
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Placebo Effect in Children With Attention Deficit Disorder andor Hyperactivity Disorder
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADE
Brief Summary:
In Quebec there has been an important increase of Attention Deficit Hyperactivity Disorder ADHD diagnosis since 2015 ADHD symptoms related to behavioural andor concentration difficulties are very similar to other disorders symptoms such as anxiety and depression and have a significant impact on students academic success and future life Adults parent teacher coach expectations towards a childs abilities are consciously or unconsciously perceived by the child influence his expectations of his own abilities and thus his academic performance Pygmalion effect The child and his entourages expectations are therefore a major factor to consider especially in school-age children According to ADHD studies some brain areas involved in pain regulation and in attention cognitive abilities develop at a slower rate in children with ADHD than the other children
Considering the deleterious consequences generated by the symptoms of this disorder the research project aims to better understand the role of expectations in children with ADHD in a medical pain and school attention abilities context It also aims to contribute to better understand the role of the brain on the expectations effect and ADHD In this study children expectations will be modulated while pain experiments and cognitive task will be realized by children with and without ADHD Brain measures will also be assessed with advanced techniques
Thus we hope that the results will help improve intervention strategies in these contexts to ensure better support for children with ADHD with a distant goal of contributing to the development of stronger tools for differential diagnostics
Considering the deleterious consequences generated by the symptoms of this disorder the research project aims to better understand the role of expectations in children with ADHD in a medical pain and school attention abilities context It also aims to contribute to better understand the role of the brain on the expectations effect and ADHD In this study children expectations will be modulated while pain experiments and cognitive task will be realized by children with and without ADHD Brain measures will also be assessed with advanced techniques
Thus we hope that the results will help improve intervention strategies in these contexts to ensure better support for children with ADHD with a distant goal of contributing to the development of stronger tools for differential diagnostics
Detailed Description:
Attention Deficit with or without Hyperactivity Disorder ADHD is a neurodevelopmental disorder that affects 2 to 7 worldwide youth population and 62 of children aged 6 to 11 years in Quebec 1-3 The main symptoms of this disorder are difficulties in regulating behaviour andor concentration 4 These difficulties have significant negative consequences in someones life particularly in terms of their academic success 5 and has significant negative consequences in the medical context increasing accidents and mortality risk 6
Childrens academic performance can be modulated by the Pygmalion or Rosenthal effect which refers to an improvement or decrease in an individuals performance depending on the degree of belief in his or her abilities on the part of an authority or the environment 7 Thus these beliefs have an influence on a persons expectations of his or her ability to do a task and thus on final performance 8 The expectations of an individual and his or her entourage is therefore a major factor to consider especially in school-age children 9 Expectations also play an important role in the placebo effect Whereas a placebo is a treatment without any real influence on a particular condition drug or therapeutic technique the placebo effect is the perceived beneficial effect following this treatment Furthermore a placebo effect is almost always added to the beneficial effect of a treatment in different ways for example an analgesic effect could occur faster or in a shorter delay and to different degrees 10 The placebo effect is regularly studied and increasingly understood in the context of pain 11 Although the perception of pain is influenced by placebo treatment this effect is itself modulated by the expectations of the person in pain 12 The dorsolateral prefrontal cortex DLPFC is an essential region for the placebos mechanism of action 10 In children with ADHD there is a delay in the maturation of the cortical thickness of DLPFC between the ages of 7 and 10 years 13 These differences in neuronal activity in the prefrontal region are associated with difficulties in attention control and inhibition in these children inhibitory functions measured using transcranial magnetic stimulation TMS show a lower inhibition capacity in individuals with ADHD than without ADHD 14
Considering the important consequences generated by the symptoms of this disorder it is essential to better understand the role of the placebonocebo effect and expectations in children with ADHD in a medical pain and academic attentional skills context Our goal is to better understand how this placebonocebo effects and expectations are associated with changes in the DLPFC and the inhibitory functions This study also aims to better characterize the role of neurophysiological and neuroanatomical factors in these contexts with the distant goal of contributing to the development of stronger tools for differential diagnostics
Objectives 1 To compare the placebonocebo effect on pain and 2 on attention abilities in children with and without ADHD 3 To determine if there is a relationship between the placebonocebo effect and neurophysiological inhibitory mechanisms and neuroanatomical DLPFC measures
Assumptions
1 Children with ADHD will have a weaker response to the placebonocebo effect on pain and 2 on attention abilities than children without ADHD 3 There is a moderate to strong association between the placebonocebo effect and neurophysiological neuroanatomical markers
Methodology Data will be collected from 44 children 22 with ADHD and 22 without ADHD
At the first session we will proceed with the experimentation of the placebo and nocebo effect on pain and on the ability to perform cognitive tasks The experiment will be divided into two parts a placebo part where the participant will have to take a drug inactive placebo that improves cognitive abilities and pain tolerance for a short period of time and a nocebo part where the participant will have to take a drug inactive nocebo that decreases cognitive abilities and pain tolerance for a short period of time The placebonocebo effect will be induced using an inactive capsule that increases or reduces depending on the experimenters discourse general cognitive skills as well as sensitivity and tolerance to pain Following the administration of each capsule we will proceed with the pain and attention experiments all in a randomized order Between the two parts of the experimentation we will proceed to the questionnaire administration with the participant Since all the steps are approximately 45 minutes in length we will be able to plan a session with participants lasting between one and one and a half hours
In the second session we will perform the neurophysiological inhibitory mechanisms and neuroanatomical DLPFC measures At the end of the visit we will also proceed with a review of the study in order to disclose the information that was obscured during the project An explanatory document containing this information and the participants detailed participation will also be given to the parent and the child
Analyses T-tests will be used to assess the effect of expectations on pain in children with ADHD compared to children without ADHD Objective 1 The same analyses will be conducted to compare the effect of expectations on the ability to perform attentional cognitive tasks between the two groups objective 2 For objective 3 simple regressions will first be used to determine whether there is an association between independent variables neurophysiological and neuranatomical measures and the effect of expectations on pain and cognitive tasks Potentially predictive variables with a p-value 015 on the correlation test will be retained for the development of the multiple regression model All possible models and therefore all subsets of the variables retained in the previous step will be considered Statistical criteria R2 adjusted R2 and Mallows Cp as well as a critical clinical judgment will allow us to decide on the best model This final model will only include variables with a beta coefficient that is significantly non-zero at the alpha level of 005
Non-parametric analyses will also be performed to determine if significant results can be obtained In addition to providing preliminary results this study will provide the statistical parameters mean standard deviation required to calculate the sample size
Contributions Research This study could contribute to a better understanding of the role of expectations in children with ADHD in a medical pain and academic attentional skills context It will also allow us to better understand the role of DLPFC in the mechanism of the placebonocebo effect
Clinic As a result it will be potentially possible to improve the intervention strategies to be implemented in order to ensure better support for children with ADHD also in the medical pain and school attentional skills contexts This study may also allow a better general understanding and evaluation of the disorder and thus reduce prejudice towards children with ADHD
Childrens academic performance can be modulated by the Pygmalion or Rosenthal effect which refers to an improvement or decrease in an individuals performance depending on the degree of belief in his or her abilities on the part of an authority or the environment 7 Thus these beliefs have an influence on a persons expectations of his or her ability to do a task and thus on final performance 8 The expectations of an individual and his or her entourage is therefore a major factor to consider especially in school-age children 9 Expectations also play an important role in the placebo effect Whereas a placebo is a treatment without any real influence on a particular condition drug or therapeutic technique the placebo effect is the perceived beneficial effect following this treatment Furthermore a placebo effect is almost always added to the beneficial effect of a treatment in different ways for example an analgesic effect could occur faster or in a shorter delay and to different degrees 10 The placebo effect is regularly studied and increasingly understood in the context of pain 11 Although the perception of pain is influenced by placebo treatment this effect is itself modulated by the expectations of the person in pain 12 The dorsolateral prefrontal cortex DLPFC is an essential region for the placebos mechanism of action 10 In children with ADHD there is a delay in the maturation of the cortical thickness of DLPFC between the ages of 7 and 10 years 13 These differences in neuronal activity in the prefrontal region are associated with difficulties in attention control and inhibition in these children inhibitory functions measured using transcranial magnetic stimulation TMS show a lower inhibition capacity in individuals with ADHD than without ADHD 14
Considering the important consequences generated by the symptoms of this disorder it is essential to better understand the role of the placebonocebo effect and expectations in children with ADHD in a medical pain and academic attentional skills context Our goal is to better understand how this placebonocebo effects and expectations are associated with changes in the DLPFC and the inhibitory functions This study also aims to better characterize the role of neurophysiological and neuroanatomical factors in these contexts with the distant goal of contributing to the development of stronger tools for differential diagnostics
Objectives 1 To compare the placebonocebo effect on pain and 2 on attention abilities in children with and without ADHD 3 To determine if there is a relationship between the placebonocebo effect and neurophysiological inhibitory mechanisms and neuroanatomical DLPFC measures
Assumptions
1 Children with ADHD will have a weaker response to the placebonocebo effect on pain and 2 on attention abilities than children without ADHD 3 There is a moderate to strong association between the placebonocebo effect and neurophysiological neuroanatomical markers
Methodology Data will be collected from 44 children 22 with ADHD and 22 without ADHD
At the first session we will proceed with the experimentation of the placebo and nocebo effect on pain and on the ability to perform cognitive tasks The experiment will be divided into two parts a placebo part where the participant will have to take a drug inactive placebo that improves cognitive abilities and pain tolerance for a short period of time and a nocebo part where the participant will have to take a drug inactive nocebo that decreases cognitive abilities and pain tolerance for a short period of time The placebonocebo effect will be induced using an inactive capsule that increases or reduces depending on the experimenters discourse general cognitive skills as well as sensitivity and tolerance to pain Following the administration of each capsule we will proceed with the pain and attention experiments all in a randomized order Between the two parts of the experimentation we will proceed to the questionnaire administration with the participant Since all the steps are approximately 45 minutes in length we will be able to plan a session with participants lasting between one and one and a half hours
In the second session we will perform the neurophysiological inhibitory mechanisms and neuroanatomical DLPFC measures At the end of the visit we will also proceed with a review of the study in order to disclose the information that was obscured during the project An explanatory document containing this information and the participants detailed participation will also be given to the parent and the child
Analyses T-tests will be used to assess the effect of expectations on pain in children with ADHD compared to children without ADHD Objective 1 The same analyses will be conducted to compare the effect of expectations on the ability to perform attentional cognitive tasks between the two groups objective 2 For objective 3 simple regressions will first be used to determine whether there is an association between independent variables neurophysiological and neuranatomical measures and the effect of expectations on pain and cognitive tasks Potentially predictive variables with a p-value 015 on the correlation test will be retained for the development of the multiple regression model All possible models and therefore all subsets of the variables retained in the previous step will be considered Statistical criteria R2 adjusted R2 and Mallows Cp as well as a critical clinical judgment will allow us to decide on the best model This final model will only include variables with a beta coefficient that is significantly non-zero at the alpha level of 005
Non-parametric analyses will also be performed to determine if significant results can be obtained In addition to providing preliminary results this study will provide the statistical parameters mean standard deviation required to calculate the sample size
Contributions Research This study could contribute to a better understanding of the role of expectations in children with ADHD in a medical pain and academic attentional skills context It will also allow us to better understand the role of DLPFC in the mechanism of the placebonocebo effect
Clinic As a result it will be potentially possible to improve the intervention strategies to be implemented in order to ensure better support for children with ADHD also in the medical pain and school attentional skills contexts This study may also allow a better general understanding and evaluation of the disorder and thus reduce prejudice towards children with ADHD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None