Effect of cognitive rehabilitation of spatial ability on improvement of executive and attentional functions in children with attention deficit hyperactivity disorder
Evaluating the Effectiveness of Spatial Cognitive Rehabilitation on Executive and Attentional Functions in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Design
This study is a randomized parallel-group clinical trial in which participants are randomly assigned to intervention and control groups and assessed at pre-test and post-test.
Settings and conduct
The study will be conducted in child psychiatry and psychology clinics affiliated with the university. After screening and enrollment, eligible participants will undergo baseline assessments. The intervention group will participate in cognitive rehabilitation sessions, while the control group will continue routine treatment. Outcome measures will be assessed before and after the intervention period.
Participants/Inclusion and exclusion criteria
Children aged 9–12 years with ADHD and a Conners score above 40 will be included. Children with neurological disorders, autism, learning disorders, anxiety, depression, intellectual disability, sensory impairments, or lack of cooperation will be excluded.
Intervention groups
Intervention group: Methylphenidate plus the PARSA spatial cognitive rehabilitation program.
Control group: Methylphenidate plus the AREF cognitive training program as a placebo control intervention.
Main outcome variables
The primary outcome variables include executive functions and attentional performance in children with ADHD. These variables will be assessed using standardized neuropsychological instruments and behavioral rating scales before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240127060825N2
Registration date:2026-06-20, 1405/03/30
Registration timing:retrospective
Last update:2026-06-20, 1405/03/30
Update count:0
Registration date
2026-06-20, 1405/03/30
Registrant information
Name
Hajar Sabet
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 936 715 4966
Email address
h.sabet@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
2024-07-10, 1403/04/20
Actual recruitment end date
2025-02-20, 1403/12/02
Trial completion date
2025-03-29, 1404/01/09
Scientific title
Effect of cognitive rehabilitation of spatial ability on improvement of executive and attentional functions in children with attention deficit hyperactivity disorder
Public title
Effect of cognitive rehabilitation of spatial ability in children with attention deficit hyperactivity disorder
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a child psychiatrist based on DSM diagnostic criteria.
Completion of the Conners Rating Scale by the parents of the mentioned children and obtaining a score higher than 40.
The child’s age should be between 9 and 12 years.
The child should be right-handed.
Exclusion criteria:
Lack of willingness, readiness, or cooperation of the child to participate in the study.
Use of medications other than methylphenidate.
Presence of neurological disorders such as seizures, cerebral palsy, visual impairments, or hearing impairments.
Presence of psychological disorders such as depression, anxiety disorders, learning disorders, or autism spectrum disorder.
Intelligence quotient (IQ) below the normal range.
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly allocated into intervention and control groups using simple randomization at the individual level. A computer-generated random number table was used to create the random allocation sequence. The randomization sequence was generated by a researcher who was not involved in the assessment process. Allocation concealment was performed using sealed opaque envelopes to prevent prediction of group assignment before participant allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the cognitive rehabilitation intervention, blinding of participants and therapists delivering the intervention was not feasible. However, outcome assessments and data scoring procedures were conducted by an evaluator who was unaware of the participants’ group allocation in order to minimize assessment bias. In addition, standardized neuropsychological measures and structured assessment procedures were used to reduce the potential influence of observer expectancy effects.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics comittees of shahid beheshti university
Street address
Shahid Beheshti University of Medical Sciences and Health Services Administrative Headquarters, Building No. 2, 6th Floor Arabi Street, Yemen Street Shahid Chamran Expressway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-07-06, 1403/04/16
Ethics committee reference number
IR.SBU.REC.1403.084
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder (ADHD)
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Change in working memory assessed by the N-Back Test
Timepoint
Working memory was assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions.
Method of measurement
N-Back Test
2
Description
Change in response inhibition assessed by the Go/No-Go Test
Timepoint
Cognitive flexibility was assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions.
Method of measurement
Wisconsin Card Sorting Test
3
Description
Change in response inhibition assessed by the Go/No-Go Test
Timepoint
Response inhibition was assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions.
Method of measurement
Go/No-Go Test
4
Description
Change in attentional networks assessed by the Attention Network Test (ANT)
Timepoint
Atentional Networks were assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions.
Method of measurement
Attention Network Test
Secondary outcomes
1
Description
Spatial ability was assessed using the Spatial Ability Test of the PARSA cognitive rehabilitation software.
Timepoint
Spatial abilities were assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions.
Method of measurement
Gardner Test of Visual Perceptual Skills
Intervention groups
1
Description
Intervention group: The intervention group received 10 sessions of cognitive rehabilitation using the PARSA Spatial Ability Program. Sessions were conducted twice weekly and lasted 60 minutes each. Participants performed computerized spatial ability training exercises during each session. A cognitive rehabilitation therapist was present throughout the sessions to provide guidance and assistance whenever needed.
Category
Rehabilitation
2
Description
Control group: Participants in the control group received 10 sessions of the AREF Emotional Perception Cognitive Rehabilitation Program as an active control intervention. Sessions were conducted once weekly and lasted 15 minutes each.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling Center, Shahid Beheshti University
Full name of responsible person
Hajar Sabet
Street address
Daneshjoo Blvd, Next to the Student Cultural Center, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2365
Email
info@sbu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Reza khosroabadi
Street address
Daneshjoo Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2365
Email
info@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Uni versity
Full name of responsible person
Hajar Sabet
Position
Master student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.33, Alley 27, Zendan Crossroad, south Edalat Blvd., Shiraz Town,
City
Shiraz
Province
Fars
Postal code
7168868875
Phone
+98 71 3824 5103
Email
hajarsabet@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Uni versity
Full name of responsible person
Hajar Sabet
Position
Master student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.33, Alley 27, Zendan Crossroad, south Edalat Blvd., Shiraz Town,
City
Shiraz
Province
Fars
Postal code
7168868875
Phone
+98 71 3824 5103
Email
hajarsabet@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Hajar Sabet
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 33, 27 alley, Edalat Blvd., POB: 7168868875
City
Shiraz
Province
Fars
Postal code
7168868875
Phone
+98 936 715 4966
Fax
Email
h.sabet@mail.sbu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual participant data will not be shared in order to protect participant confidentiality and comply with ethical considerations. The data involve children and were collected solely for the purposes of this study.