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.
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Protocol summary
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.
This study was designed as a randomized, controlled, parallel-group clinical trial involving 80 patients. Random allocation was performed using the RAND function in Microsoft Excel."
A 12This study was designed as a randomized, controlled, parallel-week group intervention consisting of 12 weekly 90-minute sessionsclinical trial involving 80 patients. The program teaches mindfulness techniques withRandom allocation was performed using the aim of enhancing attentional self-management, intentional focus, emotion self-regulation, and emotional resilienceRAND function in Microsoft Excel."
کارآزمایی بالینی دارای گروه کنترل و گروه مداخله متقاطع، تصادفی شده،روی 80 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد
کارآزمایی بالینی دارای گروه کنترل و گروه موازی، تصادفی شده،روی 80 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد
کارآزمایی بالینی دارای گروه کنترل و گروه مداخله متقاطعموازی، تصادفی شده،روی 80 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد
General information
Crossover
Parallel
crossparal
empty
The study was initially designed as a **crossover randomized controlled trial (RCT)** because this design has been employed in certain intervention studies to enhance statistical efficiency, reduce inter-individual variability, and ensure that all participants eventually receive the intervention. However, following a more thorough methodological review and expert feedback on the design of pediatric psychological trials, it became evident that a crossover design presents important limitations for mindfulness-based interventions, particularly **Mindfulness-Based Cognitive Therapy for Children (MBCT-C)**.
A fundamental assumption of a crossover design is that the effects of the intervention are reversible or can be eliminated after the treatment phase, allowing participants to return to their baseline state following an adequate washout period. This assumption is not applicable to MBCT-C, as the intervention is specifically intended to produce enduring improvements in attentional regulation, emotional awareness, self-regulation, and behavioral control. The skills acquired during treatment are expected to persist beyond the intervention period and may even become further consolidated over time. Consequently, the likelihood of **carryover effects** is substantial, making it difficult to interpret post-crossover comparisons and potentially compromising the internal validity of the study.
Accordingly, the study design was revised to a **parallel-group randomized controlled trial**. In this design, participants remain in their originally assigned groups following randomization, and the effectiveness of MBCT-C is evaluated by comparing the intervention group with the waitlist control group at the post-intervention assessment. This approach enables a clearer and more valid evaluation of the intervention by eliminating the risk of contamination resulting from prior exposure to treatment.
Furthermore, adopting a parallel-group design simplifies the statistical analysis by eliminating the need to model **sequence effects**, **period effects**, and **carryover effects**, thereby improving the clarity and interpretability of the analytical strategy. This modification is also more consistent with the theoretical and clinical foundations of MBCT-C, in which the maintenance and consolidation of learned mindfulness skills are considered integral components of the therapeutic mechanism rather than factors that can be fully removed or controlled. Therefore, from both methodological and clinical perspectives, a parallel-group randomized controlled trial represents a more appropriate and scientifically rigorous design for evaluating the effectiveness of MBCT-C.
The study was initially designed as a **crossover randomized controlled trial (RCT)** because this design has been employed in certain intervention studies to enhance statistical efficiency, reduce inter-individual variability, and ensure that all participants eventually receive the intervention. However, following a more thorough methodological review and expert feedback on the design of pediatric psychological trials, it became evident that a crossover design presents important limitations for mindfulness-based interventions, particularly **Mindfulness-Based Cognitive Therapy for Children (MBCT-C)**. A fundamental assumption of a crossover design is that the effects of the intervention are reversible or can be eliminated after the treatment phase, allowing participants to return to their baseline state following an adequate washout period. This assumption is not applicable to MBCT-C, as the intervention is specifically intended to produce enduring improvements in attentional regulation, emotional awareness, self-regulation, and behavioral control. The skills acquired during treatment are expected to persist beyond the intervention period and may even become further consolidated over time. Consequently, the likelihood of **carryover effects** is substantial, making it difficult to interpret post-crossover comparisons and potentially compromising the internal validity of the study. Accordingly, the study design was revised to a **parallel-group randomized controlled trial**. In this design, participants remain in their originally assigned groups following randomization, and the effectiveness of MBCT-C is evaluated by comparing the intervention group with the waitlist control group at the post-intervention assessment. This approach enables a clearer and more valid evaluation of the intervention by eliminating the risk of contamination resulting from prior exposure to treatment. Furthermore, adopting a parallel-group design simplifies the statistical analysis by eliminating the need to model **sequence effects**, **period effects**, and **carryover effects**, thereby improving the clarity and interpretability of the analytical strategy. This modification is also more consistent with the theoretical and clinical foundations of MBCT-C, in which the maintenance and consolidation of learned mindfulness skills are considered integral components of the therapeutic mechanism rather than factors that can be fully removed or controlled. Therefore, from both methodological and clinical perspectives, a parallel-group randomized controlled trial represents a more appropriate and scientifically rigorous design for evaluating the effectiveness of MBCT-C.
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طراحی اولیه مطالعه بهصورت crossover randomized controlled trial در نظر گرفته شده بود، زیرا این نوع طراحی در برخی مطالعات مداخلهای با هدف افزایش کارایی آماری، کاهش واریانس بینفردی، و فراهم کردن امکان دریافت مداخله برای تمامی شرکتکنندگان مورد استفاده قرار میگیرد. با این حال، پس از بازبینی دقیقتر ملاحظات روششناختی مطالعه و دریافت بازخورد تخصصی در زمینه طراحی کارآزماییهای روانشناختی کودک، مشخص شد که طراحی متقاطع برای مداخلات مبتنی بر ذهنآگاهی، بهویژه MBCT-C، محدودیتهای مهمی ایجاد میکند. یکی از پیشفرضهای اساسی در طراحی crossover این است که اثرات مداخله پس از پایان فاز درمانی قابل حذف یا بازگشت به خط پایه باشند. این در حالی است که MBCT-C با هدف ایجاد تغییرات پایدار در تنظیم توجه، آگاهی هیجانی، خودتنظیمی و کنترل رفتاری طراحی شده است و انتظار میرود مهارتهای آموختهشده پس از پایان جلسات نیز حفظ و حتی در طول زمان تثبیت شوند. بنابراین، احتمال carryover effects در این نوع مداخله بالا بوده و این مسئله میتواند تفسیر مقایسههای پس از crossover را با دشواری همراه سازد و اعتبار درونی مطالعه را تحت تأثیر قرار دهد.
بر این اساس، پیشنهاد میشود طراحی مطالعه به parallel-group randomized controlled trial تغییر یابد تا امکان ارزیابی شفافتر و معتبرتر اثربخشی MBCT-C فراهم شود. در طراحی موازی، مقایسه بین گروه مداخله و گروه waitlist در مرحله post-intervention بدون آلودگی ناشی از دریافت قبلی درمان انجام میشود و در نتیجه تفسیر یافتهها سادهتر و از نظر روششناختی قابلاتکاتر خواهد بود. علاوه بر این، حذف ساختار crossover نیاز به مدلسازی اثرات sequence، period و carryover را برطرف میکند و موجب افزایش وضوح راهبرد تحلیلی مطالعه میشود. این تغییر همچنین همخوانی بیشتری با ماهیت بالینی MBCT-C دارد، زیرا در مداخلات مبتنی بر ذهنآگاهی، تداوم و تثبیت مهارتها بخشی از سازوکار درمان محسوب میشود و نه عاملی که بتوان آن را بهطور کامل حذف یا کنترل کرد
طراحی اولیه مطالعه بهصورت crossover randomized controlled trial در نظر گرفته شده بود، زیرا این نوع طراحی در برخی مطالعات مداخلهای با هدف افزایش کارایی آماری، کاهش واریانس بینفردی، و فراهم کردن امکان دریافت مداخله برای تمامی شرکتکنندگان مورد استفاده قرار میگیرد. با این حال، پس از بازبینی دقیقتر ملاحظات روششناختی مطالعه و دریافت بازخورد تخصصی در زمینه طراحی کارآزماییهای روانشناختی کودک، مشخص شد که طراحی متقاطع برای مداخلات مبتنی بر ذهنآگاهی، بهویژه MBCT-C، محدودیتهای مهمی ایجاد میکند. یکی از پیشفرضهای اساسی در طراحی crossover این است که اثرات مداخله پس از پایان فاز درمانی قابل حذف یا بازگشت به خط پایه باشند. این در حالی است که MBCT-C با هدف ایجاد تغییرات پایدار در تنظیم توجه، آگاهی هیجانی، خودتنظیمی و کنترل رفتاری طراحی شده است و انتظار میرود مهارتهای آموختهشده پس از پایان جلسات نیز حفظ و حتی در طول زمان تثبیت شوند. بنابراین، احتمال carryover effects در این نوع مداخله بالا بوده و این مسئله میتواند تفسیر مقایسههای پس از crossover را با دشواری همراه سازد و اعتبار درونی مطالعه را تحت تأثیر قرار دهد. بر این اساس، پیشنهاد میشود طراحی مطالعه به parallel-group randomized controlled trial تغییر یابد تا امکان ارزیابی شفافتر و معتبرتر اثربخشی MBCT-C فراهم شود. در طراحی موازی، مقایسه بین گروه مداخله و گروه waitlist در مرحله post-intervention بدون آلودگی ناشی از دریافت قبلی درمان انجام میشود و در نتیجه تفسیر یافتهها سادهتر و از نظر روششناختی قابلاتکاتر خواهد بود. علاوه بر این، حذف ساختار crossover نیاز به مدلسازی اثرات sequence، period و carryover را برطرف میکند و موجب افزایش وضوح راهبرد تحلیلی مطالعه میشود. این تغییر همچنین همخوانی بیشتری با ماهیت بالینی MBCT-C دارد، زیرا در مداخلات مبتنی بر ذهنآگاهی، تداوم و تثبیت مهارتها بخشی از سازوکار درمان محسوب میشود و نه عاملی که بتوان آن را بهطور کامل حذف یا کنترل کرد
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
This study was designed as a randomized, controlled, parallel-group clinical trial involving 80 patients. Random allocation was performed using the RAND function in Microsoft Excel."
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
The study was initially designed as a **crossover randomized controlled trial (RCT)** because this design has been employed in certain intervention studies to enhance statistical efficiency, reduce inter-individual variability, and ensure that all participants eventually receive the intervention. However, following a more thorough methodological review and expert feedback on the design of pediatric psychological trials, it became evident that a crossover design presents important limitations for mindfulness-based interventions, particularly **Mindfulness-Based Cognitive Therapy for Children (MBCT-C)**.
A fundamental assumption of a crossover design is that the effects of the intervention are reversible or can be eliminated after the treatment phase, allowing participants to return to their baseline state following an adequate washout period. This assumption is not applicable to MBCT-C, as the intervention is specifically intended to produce enduring improvements in attentional regulation, emotional awareness, self-regulation, and behavioral control. The skills acquired during treatment are expected to persist beyond the intervention period and may even become further consolidated over time. Consequently, the likelihood of **carryover effects** is substantial, making it difficult to interpret post-crossover comparisons and potentially compromising the internal validity of the study.
Accordingly, the study design was revised to a **parallel-group randomized controlled trial**. In this design, participants remain in their originally assigned groups following randomization, and the effectiveness of MBCT-C is evaluated by comparing the intervention group with the waitlist control group at the post-intervention assessment. This approach enables a clearer and more valid evaluation of the intervention by eliminating the risk of contamination resulting from prior exposure to treatment.
Furthermore, adopting a parallel-group design simplifies the statistical analysis by eliminating the need to model **sequence effects**, **period effects**, and **carryover effects**, thereby improving the clarity and interpretability of the analytical strategy. This modification is also more consistent with the theoretical and clinical foundations of MBCT-C, in which the maintenance and consolidation of learned mindfulness skills are considered integral components of the therapeutic mechanism rather than factors that can be fully removed or controlled. Therefore, from both methodological and clinical perspectives, a parallel-group randomized controlled trial represents a more appropriate and scientifically rigorous design for evaluating the effectiveness of MBCT-C.
Acronym
IRCT registration information
IRCT registration number:IRCT20241008063301N1
Registration date:2025-08-19, 1404/05/28
Registration timing:prospective
Last update:2026-07-30, 1405/05/08
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
Parallel
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