Comparing the effectiveness of emotion regulation-based play therapy with child-centered mindfulness-based intervention on adjustment, emotion management, and executive functions of children with attention deficit hyperactivity disorder (ADHD)
To compare the effectiveness of emotion regulation-based play therapy and child-centered mindfulness intervention on adjustment, emotion management, and executive functions in children with attention-deficit/hyperactivity disorder.
Design
This is a randomized, three-arm, controlled, pretest–posttest quasi-experimental trial involving 45 participants, randomly allocated to two intervention groups and one control group using sealed-envelope randomization.
Settings and conduct
The study will be conducted in counseling centers in Yasuj, Iran, among children with ADHD. A total of 45 eligible participants will be selected using purposive sampling and randomly allocated to two intervention groups and one control group. Data will be analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children aged 6–12 years with a DSM-5 diagnosis of ADHD. Written parental informed consent and child assent. No related pharmacological or psychological treatment within the previous 6 months. Exclusion Criteria: Severe psychiatric comorbidities or learning disabilities. Current use of psychiatric medications. Withdrawal from the study or absence from more than two intervention sessions.
Intervention groups
Intervention Group 1: Participants will receive emotion-based play therapy in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol.
Intervention Group 2: Participants will receive child-centered mindfulness training in eight face-to-face group sessions, each lasting 90 minutes.
Control Group: Participants will receive no intervention during the study period and will continue with routine care. Outcome assessments will be performed at the same time points as in the intervention groups.
Comparing the effectiveness of emotion regulation-based play therapy with child-centered mindfulness-based intervention on adjustment, emotion management, and executive functions of children with attention deficit hyperactivity disorder (ADHD)
Public title
Comparing the effectiveness of emotion-focused and child-centered mindfulness play therapy on children's adjustment, emotion regulation, and executive functioning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6–12 years.
Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria.
Written informed consent provided by parents or legal guardians.
Child's assent to participate in the study.
No pharmacological or non-pharmacological interventions targeting executive functions or emotion regulation within the previous 6 months.
Exclusion criteria:
Comorbid autism spectrum disorder, intellectual disability, or other severe psychiatric disorders.
Severe learning disabilities interfering with participation in the intervention.
Current use of psychiatric medications that may affect study outcomes.
Withdrawal of parental consent or child assent during the study.
Absence from more than two intervention sessions.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be selected through purposive sampling and randomly allocated in a 1:1:1 ratio to two intervention groups and one control group using simple randomization. The random allocation sequence will be generated before participant enrollment using the RAND function in Microsoft Excel. Allocation concealment will be ensured using sequentially numbered, sealed, opaque envelopes prepared by an independent researcher not involved in participant recruitment or outcome assessment. After completion of the baseline assessment, each participant will be assigned to the next available envelope, which will determine group allocation.
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
Research Ethics Committee of Islamic Azad University - Yasuj Branch
Street address
Islamic Azad University, Yasuj Branch, 4th km., Si Sakht Road,Yasuj.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591493686
Approval date
2025-12-11, 1404/09/20
Ethics committee reference number
IR.IAU.YASOOJ.REC.1404.055
Health conditions studied
1
Description of health condition studied
Children with 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
Adaptability
Timepoint
Adaptability will be assessed at baseline, immediately after the intervention, and at the 2-month follow-up.
Method of measurement
Adaptability will be assessed using the Children's Adaptation Questionnaire developed by Dokhanchi (1998), consisting of 37 items rated on a 4-point Likert scale (0–3). Total scores range from 0 to 111, with higher scores indicating greater adaptability. Certain items are reverse-scored according to the questionnaire guidelines.
2
Description
Emotion management
Timepoint
Emotion management will be assessed at baseline, immediately after the intervention, and at the 2-month follow-up.
Method of measurement
Emotion management will be assessed using the Child Emotion Management Questionnaire (Zeman et al., 2001). This 38-item instrument is rated on a 3-point Likert scale (rarely, sometimes, often) and includes three subscales: anger, sadness, and worry. The total score is calculated by summing all item scores, with higher scores indicating greater emotion management difficulties.
3
Description
Executive functions
Timepoint
Executive functions will be assessed at baseline, immediately after the intervention, and at the 2-month follow-up.
Method of measurement
Executive functions will be assessed using the Executive Function Scale developed by Barclay (2012) for children and adolescents. The scale consists of 70 items rated on a 4-point Likert scale (never to always) and includes five subscales: time management, organization/problem solving, inhibition/self-control, self-motivation, and emotional regulation. The total score is calculated as the sum of all items, with higher scores indicating greater executive dysfunction.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Participants will receive no intervention during the study period and will continue with routine care. Outcome assessments will be performed at the same time points as in the intervention groups.
Category
Treatment - Other
2
Description
Intervention group: Participants will receive emotion-based play therapy in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol.
Category
Treatment - Other
3
Description
Intervention group: Participants will receive child-centered mindfulness training in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol.