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IRCT20201106049285N1 IRCT 2020-12-01 Institute of Cognitive and Brain sciences of Shahid Beheshti University Effectiveness of a cognitive rehabilitative program on the Spatial ability Designing and validating a cognitive rehabilitative program and determining its effect on the Spatial ability in children with Attention Deficit Hyperactivity Disorder 2020-02-09 anticipated 50 Complete https://irct.ir/trial/52145 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study was approved by the ethical committee of the Shahid Beheshti University (ethical code: IR.SBU.ICBS.97/1022), Randomization description: Simple randomization: In order to randomize, first all subjects who meet the inclusion criteria are selected and each subject is given a code. Selected subjects should be homogeneous in terms of gender variable. For this purpose, after the subjects were matched in pairs in terms of the desired variable, a list of pairs of subjects is prepared and randomly one of the two elements paired by lottery by an uninformed person, to the control group and Another is assigned to the experimental group, Blinding description: After the subjects were matched in pairs, a list of pairs of subjects was prepared and one of the two paired elements was randomly assigned to the control group and the other to the experimental group. None of the subjects and their parents knew which of the two groups they belonged to. N/A Attention Deficit Hyperactivity Disorder. Intervention 1: Intervention group: The Spatial Ability Cognitive Rehabilitation Program is a set of computer cognitive rehabilitation tasks designed to enhance the various factors of spatial ability. In designing this package, all eight factors related to spatial ability based on progressive exercises are intervened. All tasks have ten difficulty levels that are adjusted based on the nature of each factor, the speed of presentation of stimuli and their complexity, and the rules of the program. If the child can answer eighty percent of the items in a level correctly, he will go to a more difficult level. In designing cognitive rehabilitation exercises, important principles of cognitive rehabilitation have been considered, which are: • Tasks are hierarchically organized and based on the child's response during the sessions become more difficult. Enhances performance. • Homework can be repeated until the child reaches the desired level. • The decision to develop the program is based on the child's performance and the presence of a therapist is needed to improve the homework.The duration of each session was about sixty minutes, with the first five minutes being spent introducing the child to homework and the last ten minutes explaining homework to parents. At the same time and equal to the number of sessions intended for the rehabilitation of children in the experimental group, in order to control the relationship between the child therapist in determining the effectiveness of the rehabilitation package, the children in the control group underwent Aref intervention program. One week and then one month after the end of the treatment program, post-test was performed in both groups. After the assessments, the parents of the children in the control group were informed that they could benefit from free cognitive rehabilitation treatment if they wished. Intervention 2: Control group: the AREF cognitive rehabilitation program was used for the control group. This program includes training to recognize the emotional states of the face using graphic images. Each session consists of 150 face images with anterior and lateral views that the person must recognize the emotional state and feedback is provided to the person in the presence of the image. The intensity of the emotional manifestations gradually decreases in the next sessions. The first session is 100 percent intense and the last session is ten percent. In addition, the type of emotions during the treatment sessions is from easy to difficult and starts from happiness, anger and sadness and expands to six main emotions. The effectiveness of this treatment package has been shown to improve emotional recognition in normal children with autism. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because this study is part of my doctoral dissertation and I have not yet graduated, I am not able to share any of information.
public Solmaz Soluki
Institute of Cognitive and Brain sciences of Shahid Beheshti University, student boulevard,shahriyari squer, yaman street,chamran highway
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2243 1616 ss.solouki@yahoo.com Institute of Cognitive and Brain sciences of Shahid Beheshti University scientific سولماز سلوکی
Institute of Cognitive and Brain sciences of Shahid Beheshti University, student boulevard,shahriyari squer, yaman street,chamran highway
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2243 1616 ss.solouki@yahoo.com Institute of Cognitive and Brain sciences of Shahid Beheshti University Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosing Attention Deficit Hyperactivity Disordercombined sub-type by psychiatrists according to the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition Filling consent form by parents Higher score of the Conner's Parent Rating Scale than the cut-off point Being in the age range of 9 to 12 years 9 years 12 years Both Existing comorbid psychiatric disorders such as autism spectrum disorder, learning disorders, and so on. regular use of medication except for Methylphenidate F90.2 Attention-deficit hyperactivity disorder, combined type Rehabilitation Other Intervention group: The Spatial Ability Cognitive Rehabilitation Program is a set of computer cognitive rehabilitation tasks designed to enhance the various factors of spatial ability. In designing this package, all eight factors related to spatial ability based on progressive exercises are intervened. All tasks have ten difficulty levels that are adjusted based on the nature of each factor, the speed of presentation of stimuli and their complexity, and the rules of the program. If the child can answer eighty percent of the items in a level correctly, he will go to a more difficult level. In designing cognitive rehabilitation exercises, important principles of cognitive rehabilitation have been considered, which are: • Tasks are hierarchically organized and based on the child's response during the sessions become more difficult. Enhances performance. • Homework can be repeated until the child reaches the desired level. • The decision to develop the program is based on the child's performance and the presence of a therapist is needed to improve the homework.The duration of each session was about sixty minutes, with the first five minutes being spent introducing the child to homework and the last ten minutes explaining homework to parents. At the same time and equal to the number of sessions intended for the rehabilitation of children in the experimental group, in order to control the relationship between the child therapist in determining the effectiveness of the rehabilitation package, the children in the control group underwent Aref intervention program. One week and then one month after the end of the treatment program, post-test was performed in both groups. After the assessments, the parents of the children in the control group were informed that they could benefit from free cognitive rehabilitation treatment if they wished. Control group: the AREF cognitive rehabilitation program was used for the control group. This program includes training to recognize the emotional states of the face using graphic images. Each session consists of 150 face images with anterior and lateral views that the person must recognize the emotional state and feedback is provided to the person in the presence of the image. The intensity of the emotional manifestations gradually decreases in the next sessions. The first session is 100 percent intense and the last session is ten percent. In addition, the type of emotions during the treatment sessions is from easy to difficult and starts from happiness, anger and sadness and expands to six main emotions. The effectiveness of this treatment package has been shown to improve emotional recognition in normal children with autism. The ability to apprehend and identify a visual pattern fast, without knowing in advance what the pattern is, when the pattern is disguised or obscured in some way. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC), and Reaction Time of correct responses (RT) in the visaul closure of Test of Visual Perception Skills are considered as variables. The ability to find, apprehend, and identify a visual pattern fast, knowing in advance what is to be apprehended, when the pattern is disguised or obscured in some way. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC), and Reaction Time of correct responses (RT) in the figure ground sub test of Test of Visual Perception Skills are considered as variables. He ability to find a known visual pattern or accurately comparing one or more patterns in a visual field fast in which the patterns are not disguised or obscured. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC), and Reaction Time of correct responses (RT) in the visual discrimination sub test of Test of Visual Perception Skills are considered as variables. The ability to manipulate or transform the image of spatial patterns into other arrangements. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC), and Reaction Time of correct responses (RT) in the paper folding task are considered as variables. The ability to manipulate relatively simple visual patterns fast by whatever means (mental rotation, transformation, or otherwise). Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC), and Reaction Time of correct responses (RT) in the mental rotation task are considered as variables. The ability to the comprehension of the agreement of elements within a visual stimulus pattern and the aptitude to remain unconfused by the changing orientation in which a spatial configuration may be presented. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC), and Reaction Time of correct responses (RT) in the picture task are considered as variables. The ability to judge regarding a moving stimulus. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC) in the reception task, is considered as variable. The ability to learn, remember and, fallow a path in the environment. Timepoint: before intervention and next week and one month after intervention. Method of measurement: The Accuracy score (ACC) in the landmark memory, learning, and shortcut phases in the wayfinding task are considered as variabls. Institute of Cognitive and Brain sciences of Shahid Beheshti University Approved 2018-07-07 the ethical committee of the Shahid Beheshti University student boulevard,shahriyari squer, yaman street,chamran highway Tehran Tehran Iran (Islamic Republic of)