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IRCT20250928067398N1 IRCT 2025-10-01 Tehran University of Medical Sciences Investigating the effects of two different treatments on attention and behavior control in defiant children The effectiveness of a multidimensional intervention (transcranial direct current stimulation and skill-based cognitive-behavioral intervention) on response inhibition and attentional bias to threat in children with oppositional defiant disorder 2025-10-06 anticipated 45 Complete https://irct.ir/trial/86466 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Unit of randomization: Individual Randomization tool: SPSS software (random number generation) Sequence generation: Participants allocated equally across groups based on random numbers generated Block/stratified randomization: Not applied (small sample, homogeneous population). N/A Oppositional Defiant Disorder (ODD). Intervention 1: Intervention group: Intervention Group 1 (Transcranial Direct Current Stimulation – tDCS):Participants in this group received nine sessions of transcranial direct current stimulation (tDCS), three sessions per week for three consecutive weeks. Each session lasted approximately 20 minutes. A 2 mA direct current was applied using saline-soaked sponge electrodes with anodal placement over the left DLPFC and cathodal over the right DLPFC. The device used was CE certified and approved by the Ministry of Health. Intervention 2: Intervention group: Intervention Group 2 (Cognitive-Behavioral Skill-Based Intervention – CBT):Participants attended nine weekly training sessions (each lasting about 70 minutes). The sessions included emotional regulation, anger management, effective communication, and problem-solving skills. The intervention was delivered by the researcher under supervisor supervision using standard cognitive-behavioral techniques. Intervention 3: Control group: Participants in this group did not receive any intervention during the study period. They only participated in the pre-test and post-test assessments. After the completion of the study, optional educational sessions were provided to the control group to ensure ethical considerations. No - There is not a plan to make this available Justification or reason for not sharing IPD is Since the individual participant data are confidential and specific to a master’s thesis, public sharing is not recommended.
public Elnaz Nazer
No. 2, Unit 4, Sabzeh Alley, 73rd Square, Janbazan Gharbi St., Narmak District, Tehran, Iran
Tehran Iran (Islamic Republic of) 1648944963 +98 21 7793 9218 elinazer2@gmail.com Tehran University of Medical Sciences scientific Elnaz Nazer
No. 2, Unit 4, Sabzeh Alley, 73rd Square, Janbazan Gharbi St., Narmak District, Tehran, Iran
Tehran Iran (Islamic Republic of) 1648944963 +98 21 7793 9218 elinazer2@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of oppositional defiant disorder (ODD) by a psychiatrist or clinical psychologist based on DSM-5 criteria Written informed consent from parents for child participation Ability to attend intervention sessions and complete the required tasks Absence of severe comorbid disorders such as autism spectrum disorder or intellectual disability No regular use of psychiatric medications during the past three months 8 years 12 years Both Neurological disorders or epilepsy interfering with tDCS intervention Any medical contraindication for receiving transcranial direct current stimulation F91.3 Oppositional defiant disorder Treatment - Devices Behavior Other Intervention group: Intervention Group 1 (Transcranial Direct Current Stimulation – tDCS):Participants in this group received nine sessions of transcranial direct current stimulation (tDCS), three sessions per week for three consecutive weeks. Each session lasted approximately 20 minutes. A 2 mA direct current was applied using saline-soaked sponge electrodes with anodal placement over the left DLPFC and cathodal over the right DLPFC. The device used was CE certified and approved by the Ministry of Health. Intervention group: Intervention Group 2 (Cognitive-Behavioral Skill-Based Intervention – CBT):Participants attended nine weekly training sessions (each lasting about 70 minutes). The sessions included emotional regulation, anger management, effective communication, and problem-solving skills. The intervention was delivered by the researcher under supervisor supervision using standard cognitive-behavioral techniques. Control group: Participants in this group did not receive any intervention during the study period. They only participated in the pre-test and post-test assessments. After the completion of the study, optional educational sessions were provided to the control group to ensure ethical considerations. Response Inhibition:This variable assesses participants’ ability to inhibit impulsive responses and control behavioral reactions. It is evaluated using the computerized Stroop Color-Word Test. The main indicators are the number of correct responses, number of errors, and reaction time (in milliseconds). Decreased reaction time and error rate, along with increased accuracy, indicate improvement in response inhibition. Timepoint: Pre-test (before intervention) and Post-test (after completion of intervention sessions). Method of measurement: Response inhibition is measured using the computerized Stroop Color-Word Task. The stimuli consist of congruent and incongruent color-word pairs, and participants must identify the color of the word while ignoring its meaning. Reaction time (in milliseconds) and accuracy of responses are recorded as the main indicators. Attention Bias to Threat:This variable measures participants’ tendency to allocate attention toward threatening stimuli. It is assessed using the Dot-Probe Task involving pairs of emotional (angry, fearful, disgusted) and neutral facial images. Reaction time to the location of the probe appearing after the image pair is recorded. Reduced reaction time to threatening stimuli indicates decreased attention bias to threat. Timepoint: Pre-test (before intervention) and Post-test (after completion of intervention sessions). Method of measurement: Attention bias to threat is measured using the Dot-Probe Task. Participants view pairs of emotional (threat-related) and neutral faces and respond to the location of a probe appearing immediately after. The difference in reaction times between threat and neutral stimuli is calculated as the index of attention bias. The mean reaction time and accuracy rate of participants in the congruent and incongruent conditions of the Stroop task are measured separately. Reduced reaction time and increased accuracy in both conditions indicate improvement in cognitive processing and attentional control. Timepoint: Pre-test (before intervention) and Post-test (after completion of intervention sessions). Method of measurement: This variable is recorded using a computerized Stroop task software, calculating reaction time (in milliseconds) and response accuracy separately for congruent and incongruent conditions. The severity of Oppositional Defiant Disorder (ODD) symptoms in participants is assessed using the Child Behavior Checklist (CBCL) or the ODD subscale. Lower post-test scores compared to pre-test scores indicate a reduction in oppositional and defiant behaviors. Timepoint: Pre-test and Post-test. Method of measurement: The measurement tool is the Child Behavior Checklist (CBCL) completed by parents. The ODD subscale score is used as the indicator of disorder severity. Participants’ ability to regulate their emotions is assessed using the Emotion Regulation Checklist (ERC). Higher ERC scores indicate improved ability to manage and modulate emotional responses. Timepoint: Pre-test and Post-test. Method of measurement: The ERC questionnaire is completed by parents and includes subscales of emotion regulation and emotional lability. The total average score is calculated for analysis. Tehran University of Medical Sciences Approved 2025-09-22 Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences Central Administrative Building, Islamic Azad University of Medical Sciences – Tehran No. 16 West, Gol Yakh Gharbi St., Ayeneh Blvd., Shahid Pabarja St., Gholhak Crossroad, Shariati St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)