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IRCT20260618069861N1 IRCT 2026-10-19 Institute for Cognitive Science Studies Effectiveness of BARAN Cognitive Rehabilitation in Preschool Children with ADHD Symptoms Effectiveness of Attention Training with BARAN Cognitive Rehabilitation Program on executive functions and behavioral problems in Preschool Children with ADHD Symptoms 2025-04-17 anticipated 30 Complete https://irct.ir/trial/91129 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Attention-deficit hyperactivity disorder. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 access period will begin 6 months after publication of the resulting article and will continue for 3 years thereafter. To whom: Researchers affiliated with academic and scientific institutions who submit a reasonable and justified request for research purposes. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Zahra Khaki Bakhtiarvand
No. 12, Shahid Pebdani Alley, Basij Boulevard
Zarrin Shahr Iran (Islamic Republic of) 8471934593 +98 31 5222 9178 khaki_z@icss.ac.ir Institute for Cognitive Science Studies scientific Zahra Khaki Bakhtiarvand
No. 12, Shahid Pebdani Alley, Basij Boulevard
Zarrin Shahr Iran (Islamic Republic of) 8471934593 +98 31 5222 9178 khaki_z@icss.ac.ir Institute for Cognitive Science Studies Iran (Islamic Republic of) 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 60 months 72 months Both Having a confirmed physical impairment that prevents performing balance exercises F90.9 Attention-deficit hyperactivity disorder, unspecified type Rehabilitation Other 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. 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. 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. Zahra Khaki Bakhtiarvand (Researcher) Approved 2025-03-18 Ethics Committee of the Institute for Cognitive Science Studies Shahid Qasem Soleimani Blvd., Cognitive Science Blvd., Pardis City Pardis Tehran Iran (Islamic Republic of)