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IRCT20260426069174N1 IRCT 2026-07-12 Islamic Azad University The effect of a play therapy program with physical activity on improving attention and emotional control in children with ADHD Effectiveness of Physical Activity–Based Cognitive Behavioral Play Therapy on Attention and Emotion Regulation in Children with Attention‑Deficit/Hyperactivity Disorder (ADHD) 2026-07-06 anticipated 30 Recruiting https://irct.ir/trial/90103 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming eligibility criteria and obtaining informed consent from the parents, eligible participants will be randomly allocated to the intervention and control groups. The allocation sequence will be generated using computer-generated random numbers. Based on this sequence, each participant will be assigned to one of the two groups. Group allocation will be performed by the researcher without participant involvement. N/A Attention-Deficit/Hyperactivity Disorder (ADHD). Intervention 1: Control group: The control group receives no intervention (physical activity-based play therapy) during the study period. This group only participates in the pre-test and post-test stages (simultaneously with the intervention group), and the questionnaires are completed by their parents. For ethical considerations, educational materials or brief sessions will be offered to this group after the study’s conclusion. Intervention 2: Intervention group: Participants in this group receive physical activity-based cognitive-behavioral play therapy over 12 sessions (one 60-minute session per week). The sessions include purposeful games designed to enhance executive functions, physical exercises to improve motor coordination, and age-appropriate CBT techniques for children aged 5 to 7. The intervention focuses on increasing response inhibition, improving sustained attention, and strengthening self-control through high-activity physical tasks and structured rule-based games. Yes - There is a plan to make this available What will be shared: Intervention protocol and study implementation documents Shareable documents include the intervention protocol, parental informed consent form, and study implementation guide. These documents will be provided without participants’ identifying information, and raw individual data will not be shared. When: From study completion and publication of the results, the study documents (protocol and forms) will be available for 5 years. To whom: Qualified researchers and relevant professionals may access the non-identifiable study documents upon reasonable research or educational request and with approval from the principal investigator. Conditions: The documents may be used for research and educational purposes only, provided that the IRCT registration is properly cited and authorship rights are respected. Commercial use or any attempt to identify participants is not permitted. Where to obtain: Requests for access to the study documents should be submitted to the principal investigator/corresponding investigator through the contact information provided in the IRCT registration. How to obtain: Intervention protocol and study implementation documents Shareable documents include the intervention protocol, parental informed consent form, and study implementation guide. These documents will be provided without participants’ identifying information, and raw individual data will not be shared. Comments:
public Shekufeh Morshed Zade
2nd East St., Kianpars, Ahvaz
Ahvaz Iran (Islamic Republic of) 6155915867 +98 903 630 7694 Shekufeh.mrsh@gmail.com Islamic Azad University scientific Rahmatullah Khanmohammadi
Ahvaz Golestan-Farhangshahr Highway
ahvaz Iran (Islamic Republic of) ۶۱۳۴۹ +98 916 320 8770 rkhanmohamadi2010@gmail.com Islamic Azad University Iran (Islamic Republic of) • Diagnosis of Attention‑Deficit/Hyperactivity Disorder (ADHD) by a psychologist or psychiatrist. Age range of 5 to 7 years. Ability to participate in physical activity–based play therapy sessions (no significant motor limitations). No concurrent participation in similar therapeutic programs. Informed consent obtained from parents for the child’s participation in the study. Ability to attend and regularly participate in the treatment sessions. Normal or near‑normal intellectual functioning based on psychological evaluation. 5 years 7 years Both Diagnosis of autism spectrum disorder Moderate to severe intellectual disability Presence of serious neurological disorders (e.g., uncontrolled epilepsy) Physical illness or motor impairment that prevents participation in physical activity sessions Receiving similar psychological interventions during the study period Initiation of a new medication or change in medication dosage within the past month Lack of parental informed consent Parents’ unwillingness to participate in the study F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Behavior Behavior Control group: The control group receives no intervention (physical activity-based play therapy) during the study period. This group only participates in the pre-test and post-test stages (simultaneously with the intervention group), and the questionnaires are completed by their parents. For ethical considerations, educational materials or brief sessions will be offered to this group after the study’s conclusion. Intervention group: Participants in this group receive physical activity-based cognitive-behavioral play therapy over 12 sessions (one 60-minute session per week). The sessions include purposeful games designed to enhance executive functions, physical exercises to improve motor coordination, and age-appropriate CBT techniques for children aged 5 to 7. The intervention focuses on increasing response inhibition, improving sustained attention, and strengthening self-control through high-activity physical tasks and structured rule-based games. ADHD symptom score based on the Conners Parent Rating Scale and emotion regulation score based on the Emotion Regulation Checklist (ERC). Timepoint: Assessments are conducted at two time points: 1. Pre-test (before the intervention sessions start), 2. Post-test (immediately after completing the 12 intervention sessions). Method of measurement: Outcomes are measured using the Conners Parent Rating Scale and the Emotion Regulation Checklist (ERC), completed by parents or caregivers. The final score for each variable is calculated by summing the scores of all items based on a 4-point Likert scale. Child’s emotion regulation capacity, assessed using the ‘Emotion Regulation Checklist (ERC).’ This 24-item tool consists of two subscales (Emotion Regulation and Lability/Negativity) and is completed by parents or caregivers. Higher scores on the Emotion Regulation subscale indicate better regulatory capacity. Timepoint: Pre-test: Before the start of the intervention sessions.Post-test: Immediately after completing the 12 intervention sessions. Method of measurement: This variable is measured using the Emotion Regulation Checklist (ERC), completed by the child’s parents or caregivers. The total score for each subscale (Emotion Regulation and Lability/Negativity) is calculated by summing the scores of the items, based on a 4-point Likert scale (1 = Never, 4 = Almost Always). Islamic Azad University Approved 2026-01-10 Ethics Committee of Islamic Azad University, Ahvaz Branch Kiyan pars Movahedin Ahvaz Khouzestan Iran (Islamic Republic of)