Protocol summary

Study aim
To determine the effectiveness of the BARAN cognitive rehabilitation package on executive functions (inhibitory control, working memory, and cognitive flexibility) and behavioral problems in preschool children with Attention Deficit/Hyperactivity Disorder symptoms
Design
A randomized controlled trial with an active control group, parallel group design, non-blinded, without placebo, conducted on 30 preschool children with ADHD symptoms (15 per group). Simple randomization at the individual level was performed using SPSS version 27. No pharmacological intervention was involved.
Settings and conduct
Children were randomly assigned to receive either the BARAN cognitive-balance rehabilitation program or storytelling sessions (active control) at Atieh Occupational Therapy Clinic, Isfahan. Outcomes were assessed at baseline, post-intervention, and 1-year follow-up using the Day/Night Stroop, Corsi Block Task, Shape Trail Test, and a behavioral questionnaire.
Participants/Inclusion and exclusion criteria
Children aged 60 to 72 months with Attention Deficit/Hyperactivity Disorder symptoms, normal intelligence quotient, and parental consent. Children with confirmed physical impairment preventing participation in balance exercises were excluded.
Intervention groups
Intervention group: BARAN cognitive rehabilitation package consisting of balance-cognitive tasks in 10 sessions of 45 minutes, three times per week Active control group: Storytelling sessions in 10 sessions of 45 minutes, three times per week
Main outcome variables
Inhibitory control (Day/Night Stroop Task); Working memory (Corsi Block Task); Cognitive flexibility (Shape Trail Test-Child Version); Behavioral problems (Behavior Rating Inventory of Executive Function-Preschool Version, BRIEF-P)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260618069861N1
Registration date: 2026-10-19, 1405/07/27
Registration timing: retrospective

Last update: 2026-10-19, 1405/07/27
Update count: 0
Registration date
2026-10-19, 1405/07/27
Registrant information
Name
Zahra Khaki Bakhtiarvand
Name of organization / entity
Institute for Cognitive Science Studies
Country
Iran (Islamic Republic of)
Phone
+98 31 5222 9178
Email address
khaki_z@icss.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-17, 1404/01/28
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
2025-04-21, 1404/02/01
Actual recruitment end date
2025-05-24, 1404/03/03
Trial completion date
2026-06-14, 1405/03/24
Scientific title
Effectiveness of Attention Training with BARAN Cognitive Rehabilitation Program on executive functions and behavioral problems in Preschool Children with ADHD Symptoms
Public title
Effectiveness of BARAN Cognitive Rehabilitation in Preschool Children with ADHD Symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of Attention Deficit/Hyperactivity Disorder Age between 60 and 72 months Having normal intelligence quotient Completion of parental consent form Child's willingness and cooperation to participate in the study
Exclusion criteria:
Having a confirmed physical impairment that prevents performing balance exercises
Age
From 60 months old to 72 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was performed at the individual level. After compiling the list of eligible participants, each participant was assigned a unique identifier and entered into SPSS version 27. Using the Select Cases option in the Data menu, the Random Sample of Cases feature was applied to randomly select 50% of participants (n=15). Those selected were allocated to the intervention group, while the remaining 15 participants were assigned to the active control group. A random seed was set in SPSS to ensure complete randomization. Allocation concealment was maintained by keeping the allocation list with the principal investigator, ensuring that the session facilitator was unaware of group assignments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Institute for Cognitive Science Studies
Street address
Shahid Qasem Soleimani Blvd., Cognitive Science Blvd., Pardis City
City
Pardis
Province
Tehran
Postal code
1658344575
Approval date
2025-03-18, 1403/12/28
Ethics committee reference number
IR.UT.IRICSS.REC.1404.003

Health conditions studied

1

Description of health condition studied
Attention-deficit hyperactivity disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type

Primary outcomes

1

Description
The child's inhibitory control score, measured using the Day/Night Stroop task, was assessed before and after the intervention. The child's working memory score, measured using the Corsi Block Task, was assessed before and after the intervention. The child's cognitive flexibility score, measured using the Shape Trail Test+ (Child Version), was assessed before and after the intervention. The child's executive function-related behavioral problems score, completed by parents on the Behavior Rating Inventory of Executive Function–Preschool Version (BRIEF-P), was assessed before and after the intervention.
Timepoint
Outcomes (inhibitory control, working memory, cognitive flexibility, and behavioral problems) were measured at baseline (before the start of the intervention) and immediately after completion of the intervention (after 10 sessions, 45 minutes each, three times per week, over approximately 3–4 weeks).
Method of measurement
Day/Night Stroop Task for assessment of inhibitory control/ Corsi Block Task for assessment of working memory/ Shape Trail Test, Child Version, for assessment of cognitive flexibility/ Behavior Rating Inventory of Executive Function, Preschool Version, for assessment of executive function-related behavioral problems

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Children in this group (n=15) received the Balance-based Attentive Rehabilitation of Attention Networks (BARAN) cognitive-balance rehabilitation program. This program is based on a dual-task paradigm, involving the simultaneous performance of balance tasks and verbal-cognitive tasks. Balance tasks were graded according to 4 factors: base of support size (5 levels), upper limb position (5 levels), surface stability (2 levels), and quality of sensory information (eyes open/closed, 2 levels), yielding a total of 200 possible balance positions. Cognitive tasks comprised 10 progressive difficulty levels (e.g., naming categories, letters, and random numbers under specific conditions). The therapist first determined the child's baseline balance position (the ability to maintain balance for 30 to 60 seconds), after which the cognitive task was performed simultaneously while maintaining that balance position. Task difficulty was adjusted individually based on the child's performance in each session, with the aid of a computer program that displayed the target position and recorded performance. The intervention was delivered over 10 sessions, 45 minutes each, three times per week (approximately 3–4 weeks in total), administered by a master's student in cognitive rehabilitation at Atieh Occupational Therapy Clinic, Isfahan.
Category
Rehabilitation

2

Description
Control group: Children in this group (n=15) served as the active control group and, instead of the BARAN cognitive rehabilitation program, participated in storytelling sessions. These sessions were also held over 10 sessions, 45 minutes each, three times per week (approximately 3–4 weeks in total), matching the same frequency and duration as the intervention group, but without any balance-related or dual-task cognitive content, at the same clinic.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Atieh Occupational Therapy Clinic
Full name of responsible person
Zahra Khaki Bakhtiarvand
Street address
No. 81, Before Laleh Dead End, Mirza Kouchak Khan Bypass
City
Esfahan
Province
Isfehan
Postal code
8176633893
Phone
+98 31 3786 8640
Email
zahrakhaki29@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Sohrab Hajizadeh
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd., Shahid Ghasem Soleimani Blvd
City
Pardis
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Fax
+98 21 7629 1140
Email
info@icss.ac.ir
Web page address
https://icss.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahra Khaki Bakhtiarvand (Researcher)
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Zahra Khaki Bakhtiarvand
Position
Master's Student in Cognitive Rehabilitation
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 12, Shahid Pebdani Alley, Basij Boulevard
City
Zarrin Shahr
Province
Isfehan
Postal code
8471934593
Phone
+98 31 5222 9178
Email
khaki_z@icss.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Zahra Khaki Bakhtiarvand
Position
Master's Student in Cognitive Rehabilitation
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 12, Shahid Pebdani Alley, Basij Boulevard
City
Zarrin Shahr
Province
Isfehan
Postal code
8471934593
Phone
+98 31 5222 9178
Email
khaki_z@icss.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Zahra Khaki Bakhtiarvand
Position
Master's Student in Cognitive Rehabilitation
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 12, Shahid Pebdani Alley, Basij Boulevard
City
Zarrin Shahr
Province
Isfehan
Postal code
8471934593
Phone
+98 31 5222 9178
Email
khaki_z@icss.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The complete de-identified individual participant dataset from this study, after full removal of identifying information (name, surname, and other identifying details), will be available for sharing. This dataset includes pre- and post-intervention and follow up scores for all 4 primary outcome variables (inhibitory control score on the Day/Night Stroop task, working memory score on the Corsi Block Task, cognitive flexibility score on the Shape Trail Test, and behavioral problems score on the Behavior Rating Inventory of Executive Function–Preschool Version), along with baseline demographic variables (age, sex, and allocated group: intervention or control). No identifying information about the children or their parents (such as name, address, or contact number) will be included in any part of the shared data.
When the data will become available and for how long
The access period will begin 6 months after publication of the resulting article and will continue for 3 years thereafter.
To whom data/document is available
Researchers affiliated with academic and scientific institutions who submit a reasonable and justified request for research purposes.
Under which criteria data/document could be used
Data and documents may be used solely for research purposes (such as meta-analysis, re-analysis, or secondary studies) with proper citation of the source. Commercial use of the data is not permitted.
From where data/document is obtainable
Requests should be sent via email to the corresponding author (Zahra Khaki Bakhtiarvand) at [khaki_z@icss.ac.ir]. Postal address: No. 81, Before Laleh Dead End, Mirza Kouchak Khan Bypass, Isfahan, Iran.
What processes are involved for a request to access data/document
Upon receipt of a request via email, the request will be reviewed by the corresponding author within 2 weeks. If approved, a Data Use Agreement will be sent to the requester, and upon signing, the data/documents will be provided within 1 month.
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