History
# Registration date Revision Id
2 2026-06-01, 1405/03/11 388747
1 2025-08-19, 1404/05/28 352061
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Studying the prevalence of subthreshold symptoms of attention deficit/hyperactivity disorder in Iranian children aged 8 to 13 years. Determining the effectiveness of mindfulness-based cognitive therapy (child version) on cognitive dissonance syndrome and on inhibitory control and behavioral problems in children with subthreshold symptoms of attention deficit/hyperactivity disorder.
Design
A 12-week group intervention consisting of 12 weekly 90-minute sessions. The program teaches mindfulness techniques with the aim of enhancing attentional self-management, intentional focus, emotion self-regulation, and emotional resilience.
Settings and conduct
Two sessions (each 45 min) were chosen and will be held in the Hamedan Province School Counseling Room every week. Accordingly, 24 sessions of 45 min will be held during the same 12 weeks. During the implementation of mindfulness-based cognitive therapy - child version, the treatment sessions will be repeatedly reviewed by the supervisors and counselors. Also, the content of the sessions will be recorded randomly and monitored by the supervising clinical psychologist with continuous feedback to the facilitator.
Participants/Inclusion and exclusion criteria
Age 10-13 years Willingness of the child to participate in the study Absence of chronic psychiatric disorders (schizophrenia spectrum, bipolar spectrum, and neurotic disorders). Receive a diagnosis of subthreshold symptoms of attention deficit/hyperactivity disorder by a clinical psychologist or psychiatrist with at least 5
Intervention groups
1: will receive mindfulness-based cognitive therapy (child version). 2: will receive a mindfulness framework without mindfulness content.
Main outcome variables
Child and Adolescent Mindfulness Questionnaire The Child and Adolescent Behavioral Problems Scale was used to measure externalizing symptoms. Cognitive Dissociation Syndrome Inhibitory Control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241008063301N1
Registration date: 2025-08-19, 1404/05/28
Registration timing: prospective

Last update: 2025-08-19, 1404/05/28
Update count: 1
Registration date
2025-08-19, 1404/05/28
Registrant information
Name
mahshad gorjian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3251 0280
Email address
mahshadgorjian1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive therapy on mindfulness on cognitive dissociation syndrome, inhibitory control, and behavioral problems in children with symptoms on the verge of attention deficit/hyperactivity disorder.
Public title
Study of cognitive therapy and mindfulness on children with hyperactivity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Cognitive Disengagement Syndrome, Inhibitory Control Behavioral Problems in Children Diagnosed with Subthreshold Attention-Deficit/Hyperactivity Disorder
Exclusion criteria:
Age
From 8 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 children will be randomly selected from the eligible participants. Their selection will be based on the number assigned to each child and will be done using the random number function in Excel. They will then be divided into groups one and two.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Science and Research Unit
Street address
HESARAK BLVD, AZAD UNIVERSITY Science and research BRANCH
City
TEHRAN
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2025-02-20, 1403/12/02
Ethics committee reference number
IR.IAU.SRB.REC.1404.039

Health conditions studied

1

Description of health condition studied
Cognitive Disengagement Syndrome, Inhibitory Control, and Behavioral Problems in Children Diagnosed with Subthreshold Attention-Deficit/Hyperactivity Disorder
ICD-10 code
ICD-10 code description
Disengagement

Primary outcomes

1

Description
Cognitive Disengagement Syndrome as mbct
Timepoint
3 month
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: will receive mindfulness-based cognitive therapy (child version). In this study, a 12-week group intervention will be conducted, consisting of 24 sessions of 45 minutes each. Each session will be held with the aim of teaching mindfulness techniques to enhance attention self-management, intentional focus, emotion self-regulation, and emotional resilience. During the implementation of this intervention, the treatment sessions will be monitored and evaluated by the supervisors and counselors. Also, the content of the sessions will be randomly recorded and monitored by a supervising clinical psychologist with continuous feedback to ensure the quality of the content and interventions.
Category
Behavior

2

Description
Intervention group 2: The mindfulness framework will receive no mindfulness content.Both types of treatment will be equal in duration and number of sessions to reduce the role of confounding variables related to the length and timing of treatment.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
GHAHAVAND SCHOOLS
Full name of responsible person
MAHSHAD GORJIAN
Street address
IMAM KHOMAINI
City
GHAHAVAND
Province
Hamadan
Postal code
6515643356
Phone
+98 918 018 1774
Email
MAHSHADGORJIAN1995@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
REZA RADFAR
Street address
IAU HESARAK TOWN
City
TEHRAN
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5239
Email
R.RADFAR@SRBIAU.AC.IR
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
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
Islamic Azad University
Full name of responsible person
MAHSHAD GORJIAN
Position
PHD STUDENT
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO 10, FARAHANI AVE., AGHAJANI BEIG CENTER, ARAMGAH SQURE
City
HAMADAN
Province
Hamadan
Postal code
6515643356
Phone
+98 918 018 1774
Email
MAHSHADGORJIAN1995@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Habibi Asgarabad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO 10, FARAHANI AVE., MADANI BLVD.
City
hamedan
Province
Hamadan
Postal code
6515643356
Phone
+98 912 238 7577
Email
Babakhabibius@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahshad Gorjian
Position
Teaching assistant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 10, farahani ave., madani blvd.
City
Hamedan
Province
Hamadan
Postal code
6515643356
Phone
+98 81 3251 0280
Fax
Email
mahshadgorjian1995@gmail.com

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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