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The effectiveness of mindfulness intervention on executive function and occupational performance of children with Attention Deficit Hyperactivity Disorder

Protocol summary

Study aim
Examining the Effectiveness of Mindfulness Interventions on Executive Function and Occupational Performance in Children with Attention Deficit/Hyperactivity Disorder
Design
A single-blind, two-group clinical trial with parallel groups includes a control group and a mindfulness intervention group. Random allocation will be based on permuted blocks of four, with a sample size of 16 children in each group (32 in total).
Settings and conduct
Mindfulness interventions are conducted in clinics and rehabilitation centers affiliated with Tehran University of Medical Sciences. The study is designed as a single-blind trial, with assessments performed by an occupational therapist who is unaware of each child's group assignment (control or intervention).
Participants/Inclusion and exclusion criteria
1. Diagnosis of Attention Deficit Hyperactivity Disorder by a child psychiatrist 2. First to third grade of elementary school 3. An IQ above 85, based on the Wechsler Intelligence Scale 4. Absence of severe behavioral disorders, based on the Strengths and Difficulties Questionnaire (SDQ) 5. Absence of comorbidity such as Autism Spectrum Disorder, neurological and orthopedic disorders 6. No previous participation in mindfulness interventions and other similar psychological interventions
Intervention groups
In both the control group and the mindfulness intervention group, children will continue their common treatment, which includes routine occupational therapy (sensory integration, perceptual-motor, and cognitive exercises) at the clinic. In addition to the standard treatment, the intervention group will receive individual mindfulness interventions three times a week for eight weeks.
Main outcome variables
The Canadian Occupational Performance Measure (COPM); The Behavior Rating Inventory of Executive Function - Second Edition (BRIEF2, Parent Form); The Child and Adolescent Mindfulness Measure (CAMM)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240706062340N1
Registration date: 2024-07-20, 1403/04/30
Registration timing: prospective

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Elham Abdoli Hezave Ghadim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7708 0901
Email address
e-abdoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-04, 1403/06/14
Expected recruitment end date
2025-03-04, 1403/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness intervention on executive function and occupational performance of children with Attention Deficit Hyperactivity Disorder
Public title
The effectiveness of mindfulness intervention on performance of children with attention deficit/hyperactivity disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a child psychiatrist First to third grade of elementary school An IQ above 85, measured by the Wechsler Intelligence Scale Absence of severe behavioral disorders, as indicated by a score of 20 to 40 on the Strengths and Difficulties Questionnaire (SDQ) showing severe behavioral problems Absence of comorbidity such as Autism Spectrum Disorder, neurological and orthopedic disorders No previous participation in mindfulness interventions and other similar psychological interventions such as Cognitive Behavioral Therapy (CBT)
Exclusion criteria:
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method Based on Permuted Block Design with Block Size of 4. In this method, participants are allocated to groups using fixed-size blocks. Permuted blocks of size 4 are used to ensure that the number of participants in each group is approximately equal. Randomization Unit: Individual Randomization Tools: Random number table and statistical software SPSS Procedure for Generating Random Sequence: Using statistical software, the allocation sequence for each block of 4 is randomly generated. To prevent pattern repetition, several different permuted blocks are created and randomly selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a single-blind clinical trial. Initial, final, and one-month follow-up assessments will be conducted by a separate occupational therapist who is proficient in the tests and unaware of each child's group allocation (control or intervention).
Placebo
Not used
Assignment
Parallel
Other design features
This research is a two-group clinical trial comprising a control group, which receives standard occupational therapy under the supervision of the principal investigator, and an intervention group that receives mindfulness training.Children diagnosed with any of the three types of ADHD (inattentive, hyperactive/impulsive, and combined) will be matched in both groups. Additionally, the groups will be matched based on grade level, gender, treatment initiation time, and medication use or non-use.In both groups, children will continue their routine occupational therapy, which includes sensory integration, perceptual-motor, and cognitive exercises at the clinic. Given the importance of meaningful participation in occupations according to fundamental occupational therapy principles, this study will use informal mindfulness exercises as an effective method to enhance focus and presence in daily activities. Informal mindfulness will be integrated into certain independent, focused activities such as yoga, eating, walking, and breathing, where mindfulness is a primary goal. Mindfulness intervention for these children will be combined with predetermined occupations and implemented in a playful manner based on the COPM for each child.Based on the COPM form completed initially by the mothers, five main occupations will be identified for each child, and three will be selected as the target occupations for the mindfulness intervention, tailored uniquely for each child. The remaining two occupations will be evaluated post-intervention to assess generalization. Each session will include a set of exercises focused on three types of mindfulness activities: breathing, body awareness, and awareness of thoughts and feelings, implemented according to the child's specific and predetermined occupations.At the beginning of the program, the therapist will conduct a task analysis for each child's related occupations. The sessions will then progress from simple to complex based on these analyses. The intervention aims to increase children's participation and motivation through mindfulness activities in the form of play and storytelling. All these activities will be presented to enhance awareness of the three aspects of breathing, body, and thoughts/feelings through mental imagery. The games will be designed based on "Mindful Games for Kids" by Kristine Sergeant, "Mindful Games" by Susan Kaiser Greenland, and "Mindfulness Activities for Children with ADHD" by Dr. Sharon Grand. The selection of games will also be based on consensus from a panel of experts.This program is designed to be delivered individually three times a week for eight weeks. Each session will last between 30 to 45 minutes, depending on the child's condition. To enhance motivation and cooperation in the therapy sessions, a token reward system will be used, where every ten tokens will result in a prize.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Nursing, Midwifery and Rehabilitation, Tehran University of
Street address
Secretariat of the Ethics Committee in Biomedical Research, University of Tehran, Keshavarz Boulevard, Qods Street Intersection, Central Building of Tehran University of Medical Sciences, 6th Floor, Room 604
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-07-09, 1403/04/19
Ethics committee reference number
IR.TUMS.FNM.REC1403.049

Health conditions studied

1

Description of health condition studied
Attention Deficit Hyperactivity Disorder (ََADHD)
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Level of mindfulness
Timepoint
Before the intervention begins, after the 8-week intervention ends, and one month after the end of the intervention (follow-up)
Method of measurement
Child and Adolescent Mindfulness Measure

2

Description
occupational performance
Timepoint
Before the intervention begins, after the 8-week intervention ends, and one month after the end of the intervention (follow-up)
Method of measurement
Canadian Occupational Performance Measure

3

Description
Satisfaction with occupational performance
Timepoint
Before the intervention begins, after the 8-week intervention ends, and one month after the end of the intervention (follow-up)
Method of measurement
Canadian Occupational Performance Measure

4

Description
Executive function
Timepoint
Before the intervention begins, after the 8-week intervention ends, and one month after the end of the intervention (follow-up)
Method of measurement
Behavior Rating Inventory of Executive Function - Second Edition (Parent Form)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The children will continue their standard treatment, which includes routine occupational therapy (sensory integration, perceptual-motor, and cognitive exercises) at the clinic. In addition, for a duration of 8 weeks, they will receive mindfulness interventions combined with occupations, delivered through play and storytelling, in 3 weekly sessions of 30-45 minutes each.
Category
Rehabilitation

2

Description
Control group: The children will continue their standard treatment, which includes routine occupational therapy (sensory integration, perceptual-motor, and cognitive exercises) at the clinic.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Elham Abdoli Hazaveh Ghadim
Street address
School of Rehabilitation, Corner of Safi Ali Shah Street, Pirch-e Shemiran, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Keshavarz Boulevard, Corner of Ghods Street, Sixth Floor, Office of the Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Tehran University of Medical Sciences
Full name of responsible person
Elham Abdoli Hazaveh Ghadim
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 82, Khabazi Alley, Sojdei St., Tehranpars, Tehran
City
Tehran
Province
Tehran
Postal code
1655741853
Phone
+98 21 7708 0901
Email
e-abdoli@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Corner of Safi Ali Shah Street, Pirch-e Shemiran, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
praji@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Abdoli Hazaveh Ghadim
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 82, Khabazi Alley, Sojdei St., Tehranpars, Tehran
City
Tehran
Province
Tehran
Postal code
1655741853
Phone
+98 21 7708 0901
Email
e-abdoli@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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