Effectiveness of Physical Activity–Based Cognitive Behavioral Play Therapy on Attention and Emotion Regulation in Children with Attention‑Deficit/Hyperactivity Disorder (ADHD)
The aim of this study is to evaluate the effectiveness of physical activity‑based play therapy on reducing the symptoms of Attention‑Deficit/Hyperactivity Disorder (ADHD) in children aged 5 to 7 years.
Design
This randomized quasi-experimental study uses a pretest-posttest control group design. 30 children with ADHD (convenience sampling) are randomly assigned into two groups of 15. Following a pretest, the intervention group completes 12 weekly 60-minute sessions of cognitive-behavioral play therapy (physical activity-based), while the control group receives no intervention. Both groups then undergo a posttest.
Settings and conduct
This study involves children with ADHD. Participants are selected through convenience sampling and randomly assigned to intervention and control groups after the pretest. The intervention group attends 12 weekly 60‑minute cognitive‑behavioral play therapy sessions based on physical activity, while the control group receives no intervention. The study is conducted in psychological service centers.
Participants/Inclusion and exclusion criteria
**Inclusion Criteria:**
Confirmed ADHD diagnosis; age 5–7; parental consent; ability to perform physical play therapy; no concurrent similar treatments.
**Exclusion Criteria:**
Severe psychiatric/neurological disorders; physical/motor disability; withdrawal of consent; missing >2 sessions.
Intervention groups
**Intervention Group:**
Participate in 12 weekly 60‑minute cognitive‑behavioral play therapy sessions focused on physical activity to reduce ADHD symptoms and enhance attention, impulse control, and hyperactivity.
**Control Group:**
No intervention; only involved in pre‑test and post‑test assessments.
Main outcome variables
Score of Attention‑Deficit/Hyperactivity Disorder (ADHD) based on the Conners Parent Rating Scale and emotion regulation score based on the Emotion Regulation Checklist (ERC).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260426069174N1
Registration date:2026-07-12, 1405/04/21
Registration timing:registered_while_recruiting
Last update:2026-07-12, 1405/04/21
Update count:0
Registration date
2026-07-12, 1405/04/21
Registrant information
Name
Shekufeh Morshedzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3390 6154
Email address
shekufeh.mrsh@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-06, 1405/04/15
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Physical Activity–Based Cognitive Behavioral Play Therapy on Attention and Emotion Regulation in Children with Attention‑Deficit/Hyperactivity Disorder (ADHD)
Public title
The effect of a play therapy program with physical activity on improving attention and emotional control in children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• 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.
Exclusion criteria:
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
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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.
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 Islamic Azad University, Ahvaz Branch
Street address
Kiyan pars Movahedin
City
Ahvaz
Province
Khouzestan
Postal code
6155616587
Approval date
2026-01-10, 1404/10/20
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.667
Health conditions studied
1
Description of health condition studied
Attention-Deficit/Hyperactivity Disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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).
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Asyabi Psychology and Counseling Clinic
Full name of responsible person
Shekufeh Morshed zadeh
Street address
2nd East St., Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
09036307694
Phone
+98 903 630 7694
Email
shekufeh.mrsh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
2nd East St., Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155915867
Phone
+98 903 630 7694
Email
shekufeh.mrsh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shekufeh Morshed Zade
Position
M.SC. Student in Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
2nd East St., Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155915867
Phone
+98 903 630 7694
Email
Shekufeh.mrsh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahmatullah Khanmohammadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ahvaz Golestan-Farhangshahr Highway
City
ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹
Phone
+98 916 320 8770
Email
rkhanmohamadi2010@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shekufeh Morshed Zade
Position
M. SC. Student in Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
2nd East St., Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155915867
Phone
+98 903 630 7694
Email
Shekufeh.mrsh@gmail.com
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
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 the data will become available and for how long
From study completion and publication of the results, the study documents (protocol and forms) will be available for 5 years.
To whom data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.