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IRCT20250504065589N1 IRCT 2025-07-10 Shahid Beheshti University of Medical Sciences Investigating the Effectiveness of the Unified Protocol for Children Attention-Deficit/Hyperactivity Disorder (ADHD) Comparing the Effectiveness of the Unified Protocol with Treatment as Usual for Children with Attention Deficit/Hyperactivity Disorder (ADHD) Comorbid with Emotional Disorders 2025-08-23 anticipated 60 Complete https://irct.ir/trial/83311 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize participants, the random sequence will be generated using a block randomization method with a block size of 4 using R software (version 4.3.2). This process will be performed by an independent statistician who will not be involved in the implementation of the intervention or the evaluation of the data. Sixty children with ADHD will be randomly assigned in a 1:1 ratio to either the intervention (Unified Protocol) or treatment as usual (TAU) groups. To ensure no bias, the group allocations will be kept in opaque sealed envelopes and will only be opened after the participant has enrolled and completed the initial assessment by the study coordinator. This procedure will ensure that the investigators responsible for the intervention and evaluation remain unaware of the group allocation until the end of the study. N/A Attention deficit hyperactivity disorder. Intervention 1: Intervention Group: Participants in the intervention group, in addition to receiving standard pharmacological treatment prescribed by a psychiatrist based on clinical protocols, will participate in a group-based psychological intervention program grounded in the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents. This protocol is a modified version of the transdiagnostic cognitive-behavioral therapy originally developed by David Barlow and colleagues in 2011 for adults, which was later adapted and tailored in 2021 by Ehrenreich and colleagues for implementation with children and their parents.The primary objective of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents is to improve emotional regulation skills, strengthen mindfulness, identify and restructure maladaptive thoughts, and enhance emotional resilience in both children and their parents. This therapeutic approach, through its transdiagnostic focus, targets a wide range of emotional difficulties such as anxiety, depression, and challenges in emotional regulation, rather than focusing on a single specific disorder. It aims to address the shared underlying psychological mechanisms across various emotional problems.The psychological intervention consists of twelve weekly group sessions, each lasting ninety minutes, conducted over a four-month period at the university’s psychology clinic. These sessions are designed to be interactive and include direct skill instruction, role-playing, group exercises, and homework assignments for both children and their parents. The structure of the sessions is as follows:Sessions 1 to 3: Teaching foundational concepts of emotional regulation and mindfulness, including deep breathing exercises and attention-focusing techniques;Sessions 4 to 6: Identifying maladaptive thoughts and training in cognitive restructuring techniques for both children and parents;Sessions 7 to 9: Practicing problem-solving strategies and managing emotional responses in challenging or stressful situations;Sessions 10 to 12: Strengthening emotional resilience and reviewing learned skills with a focus on consolidation and generalization to everyday life.Sessions will be facilitated by licensed clinical psychologists who have completed specialized training in the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents. Each group will consist of six to eight child–parent dyads to ensure effective interaction and close clinical supervision.The intervention will make use of a comprehensive set of materials, including the educational package for the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents (comprising a therapist’s manual and separate worksheets for children and parents); visual aids for teaching emotions (such as illustrated emotion cards and educational posters); progress evaluation tools (such as standardized questionnaires for assessing emotional regulation and psychological symptoms, including child anxiety and depression measures).To reinforce the learning process, homework assignments will include mindfulness exercises, daily tracking of thoughts and emotions using structured worksheets, and joint parent–child activities aimed at practicing the acquired skills. These assignments will be reviewed in subsequent sessions by the psychologists, who will provide individualized feedback. In addition to the psychological intervention, participants will receive standard pharmacological treatment based on the diagnosis made by the psychiatrist. Since the focus of this study is on the psychological intervention component, detailed information regarding the pharmacological treatment—such as the name of the medication, chemical composition, dosage, and method of administration—is determined according to standard clinical protocols under the supervision of the treating physician and is treated as a controlled variable in this study. Precise data about the medications (including brand name, manufacturer, and dosage) is documented in each participant’s medical file and will be reported in the study results if deemed necessary. The entire psychological intervention spans a period of four months. Standardized psychometric assessments will be conducted at three points in time: at baseline, mid-intervention (after session six), and post-intervention (after session twelve), in order to evaluate improvements in emotional regulation and reductions in psychological symptoms among participants. Intervention 2: Control group: Participants in the control group receive only standard medication for Attention Deficit Hyperactivity Disorder (ADHD). Prescription medications include methylphenidate (Ritalin) or atomoxetine (Strattera), which are prescribed individually according to the psychiatrist's assessment. The dosage for methylphenidate is between 0.3 and 1 mg per kilogram of body weight per day, and for atomoxetine is 0.5 to 1.2 mg/kg per day. The dosage is adjusted between 1 and 2 times per day according to the psychiatrist's opinion. The medications are purchased through reputable and licensed pharmacies, manufactured by well-known companies, and their use is under the regular supervision of a child psychiatrist and in coordination with the parents. In this group, no group psychological intervention is performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Roya Ahmadizade
No. 49, Shahid Khodami Street, Vanak Square
Tehran Iran (Islamic Republic of) 1994763611 +98 21 8866 2549 ahmadizadeh1390@gmail.com Shahid Beheshti University of Medical Sciences scientific Roya Ahmadizadeh
No. 49, Shahid Khodami Street, Vanak Square
Tehran Iran (Islamic Republic of) 1994763611 +98 21 8866 2549 ahmadizadeh1390@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) and at least one emotional disorder based on the Semi-Structured Diagnostic Interview for Schizophrenia and Mood Disorders in Children and Adolescents Across the Lifespan ( K-SADA-PL DSM-5 ) Having at least a third-level secondary education for mothers Willingness to participate in group therapy sessions Receiving a fixed dose of medication for one month prior to the start of the study 8 years 12 years Both having serious suicidal thoughts Suffering from mental retardation, autism spectrum disorders, specific learning disabilities, language disorders, and any type of acute physical illness Parent's mental disability, learning disabilities, and mental illness that leads to impaired understanding of treatment tools and protocols F90.2 Attention-deficit hyperactivity disorder, combined type Treatment - Other Treatment - Drugs Intervention Group: Participants in the intervention group, in addition to receiving standard pharmacological treatment prescribed by a psychiatrist based on clinical protocols, will participate in a group-based psychological intervention program grounded in the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents. This protocol is a modified version of the transdiagnostic cognitive-behavioral therapy originally developed by David Barlow and colleagues in 2011 for adults, which was later adapted and tailored in 2021 by Ehrenreich and colleagues for implementation with children and their parents.The primary objective of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents is to improve emotional regulation skills, strengthen mindfulness, identify and restructure maladaptive thoughts, and enhance emotional resilience in both children and their parents. This therapeutic approach, through its transdiagnostic focus, targets a wide range of emotional difficulties such as anxiety, depression, and challenges in emotional regulation, rather than focusing on a single specific disorder. It aims to address the shared underlying psychological mechanisms across various emotional problems.The psychological intervention consists of twelve weekly group sessions, each lasting ninety minutes, conducted over a four-month period at the university’s psychology clinic. These sessions are designed to be interactive and include direct skill instruction, role-playing, group exercises, and homework assignments for both children and their parents. The structure of the sessions is as follows:Sessions 1 to 3: Teaching foundational concepts of emotional regulation and mindfulness, including deep breathing exercises and attention-focusing techniques;Sessions 4 to 6: Identifying maladaptive thoughts and training in cognitive restructuring techniques for both children and parents;Sessions 7 to 9: Practicing problem-solving strategies and managing emotional responses in challenging or stressful situations;Sessions 10 to 12: Strengthening emotional resilience and reviewing learned skills with a focus on consolidation and generalization to everyday life.Sessions will be facilitated by licensed clinical psychologists who have completed specialized training in the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents. Each group will consist of six to eight child–parent dyads to ensure effective interaction and close clinical supervision.The intervention will make use of a comprehensive set of materials, including the educational package for the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Parents (comprising a therapist’s manual and separate worksheets for children and parents); visual aids for teaching emotions (such as illustrated emotion cards and educational posters); progress evaluation tools (such as standardized questionnaires for assessing emotional regulation and psychological symptoms, including child anxiety and depression measures).To reinforce the learning process, homework assignments will include mindfulness exercises, daily tracking of thoughts and emotions using structured worksheets, and joint parent–child activities aimed at practicing the acquired skills. These assignments will be reviewed in subsequent sessions by the psychologists, who will provide individualized feedback. In addition to the psychological intervention, participants will receive standard pharmacological treatment based on the diagnosis made by the psychiatrist. Since the focus of this study is on the psychological intervention component, detailed information regarding the pharmacological treatment—such as the name of the medication, chemical composition, dosage, and method of administration—is determined according to standard clinical protocols under the supervision of the treating physician and is treated as a controlled variable in this study. Precise data about the medications (including brand name, manufacturer, and dosage) is documented in each participant’s medical file and will be reported in the study results if deemed necessary. The entire psychological intervention spans a period of four months. Standardized psychometric assessments will be conducted at three points in time: at baseline, mid-intervention (after session six), and post-intervention (after session twelve), in order to evaluate improvements in emotional regulation and reductions in psychological symptoms among participants. Control group: Participants in the control group receive only standard medication for Attention Deficit Hyperactivity Disorder (ADHD). Prescription medications include methylphenidate (Ritalin) or atomoxetine (Strattera), which are prescribed individually according to the psychiatrist's assessment. The dosage for methylphenidate is between 0.3 and 1 mg per kilogram of body weight per day, and for atomoxetine is 0.5 to 1.2 mg/kg per day. The dosage is adjusted between 1 and 2 times per day according to the psychiatrist's opinion. The medications are purchased through reputable and licensed pharmacies, manufactured by well-known companies, and their use is under the regular supervision of a child psychiatrist and in coordination with the parents. In this group, no group psychological intervention is performed. Neuroticism score in the Big Five personality Questionnaire- Children Version. Timepoint: Measuring neuroticism at the beginning of the study (before the intervention), at the end of the eighth session, and one week after the intervention. Method of measurement: Big Five Personality Questionnaire- Children Version. Emotion regulation score in the Child and Adolescent Emotion Regulation Questionnaire. Timepoint: Measuring emotion regulation at the beginning of the study (before the intervention starts), at the end of the eighth session, and one week after the intervention. Method of measurement: Child and Adolescent Emotion Regulation Questionnaire. Attention deficit score in the attention problems subscale of the Child Behavior Checklist. Timepoint: Measurement of attention problem at the beginning of the study (before the intervention), at the end of the eighth session, and one week after the intervention. Method of measurement: Attention problems subscale of the Child Behavior Checklist. Impulsivity score in the Hirschfield Impulsivity Scale. Timepoint: Measurement of impulsivity at the beginning of the study (before the intervention), at the end of the eighth session, and one week after the intervention. Method of measurement: Hirschfield Impulsivity Scale. Anxiety score in Spence Child Anxiety Scale. Timepoint: Measuring anxiety at the beginning of the study (before starting the intervention), at the end of the eighth session, and one week after the intervention. Method of measurement: Spence Child Anxiety Scale. Depression score in the Children Depression Inventory. Timepoint: Measuring depression at the beginning of the study (before starting the intervention), at the end of the eighth session, and one week after the intervention. Method of measurement: Children Depression Inventory. Parental burnout score in the Parental Burnout Questionnaire. Timepoint: Measuring parental burnout at the beginning of the study (before starting the intervention), at the end of the eighth session, and one week after the intervention. Method of measurement: Parental Burnout Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2024-10-08 Research Ethics Committee of School of Medicine, Shahid Beheshti University of Medical Sciences University Headquarters Building No. 2. Shahid Beheshti University of Medical Sciences and Health Services. Erabi Street. Shahid Chamran Highway Tehran Tehran Tehran Iran (Islamic Republic of)