Designing and validating a cognitive rehabilitative program and determining its effect on the Spatial ability in children with Attention Deficit Hyperactivity Disorder
Design and validation of cognitive rehabilitation program and evaluation of its effectiveness on spatial ability of children with attention deficit hyperactivity disorder
Design
Research is a semi experimental study with pretest-posttest design and control group. Thirty children diagnosed by a psychiatrist in a private office are selected by available sampling method in Tehran. Subjects were then randomly divided into two groups of 15 experimental and control
Settings and conduct
Children with ADHD are assessed for pre-testing.The experimental group are trained in ten difficulty levels two days a week through a package designed to enhance spatial ability factors. At the same time, the children in the control group are trained to the AREF emotional recognition intervention program. The intervention place is in the rehabilitation clinic of University.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the presence of hyperactivity disorder combined type, completion of the consent form, being in the range of 9 to 12 years and the Conners score higher than the cut point
Exclusion criteria include the presence of comorbid disorders and the use of Regular medication regimen
Intervention groups
The Spatial Ability Cognitive Rehabilitation Program is a set of computer rehabilitation tasks. In designing this package, eight factors of spatial ability based on progressive exercises are intervened. Tasks have ten difficulty levels that are adjusted based on the nature of each factor, the speed of presentation of the stimuli and their complexity.
AREF cognitive rehabilitation program is used. This program includes training to recognize the emotional states of the face using graphic images.
Main outcome variables
Flexibility of Closure, Closure Speed, Perceptual Speed, Visualization, Spatial Relation, Spatial Orientation, Spatial Temporal and Wayfinding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201106049285N1
Registration date:2020-12-01, 1399/09/11
Registration timing:retrospective
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Solmaz Soluki
Name of organization / entity
Institute for Cognitive and Brain Sciences, Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7791 8116
Email address
s_soluki@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-05-05, 1399/02/16
Actual recruitment start date
2020-02-09, 1398/11/20
Actual recruitment end date
2020-05-27, 1399/03/07
Trial completion date
2020-09-07, 1399/06/17
Scientific title
Designing and validating a cognitive rehabilitative program and determining its effect on the Spatial ability in children with Attention Deficit Hyperactivity Disorder
Public title
Effectiveness of a cognitive rehabilitative program on the Spatial ability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Existing comorbid psychiatric disorders such as autism spectrum disorder, learning disorders, and so on.
regular use of medication except for Methylphenidate
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
The study was approved by the ethical committee of the Shahid Beheshti University (ethical code: IR.SBU.ICBS.97/1022).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the ethical committee of the Shahid Beheshti University
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Khoushabi's office
Full name of responsible person
Dr. Katayun Khoushabi
Street address
third floor,No. 86,Shahid Ghadiri Alley, Saadat Abad Blvd, Darya Blvd, Chamran Highway
City
Tehran
Province
Tehran
Postal code
۱۹۹۷۹۵۳۳۱۳
Phone
+98 21 8868 2100
Email
Drkhoushabi@gmail.com
2
Recruitment center
Name of recruitment center
Cognitive Rehabilitation Clinic of Shahid Beheshti University