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IRCT20250322065141N1 IRCT 2025-05-15 Mashhad University of Medical Sciences The effectiveness of the Web-Based Barkley Behavioral Training Model The effectiveness of the Web-Based Barkley Behavioral Training Model on the Caregiving Burden and Resilience of Mothers of Children with Attention Deficit Hyperactivity Disorder (ADHD) 2025-06-07 anticipated 50 Complete https://irct.ir/trial/82591 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, the block randomization method will be used to allocate samples to the intervention and control groups, ensuring a proper balance between confounding variables such as the child's age and gender. Initially, the samples will be divided into small blocks (e.g., groups of 5 individuals) based on these variables, and then they will be randomly allocated to one of the two groups (intervention or control) using the Random Allocation Software. The order of allocation in blocks of six will be determined randomly. To prevent bias, the allocation process will be conducted by an individual independent of the research team, and participants and evaluators will not be provided with information about the group assignments (blinded randomization).To prevent bias in the allocation of samples to the intervention and control groups, the method of allocation concealment will be employed. The randomization process and sample allocation will be conducted by an individual independent of the research team to ensure that researchers and participants are unaware of the group distribution, Blinding description: Blinding Description: Blinding type: Outcome assessor / Data analyst blinding (single-blind) In this study, blinding of the data analyst and outcome assessor was employed to reduce bias and increase internal validity. The individual responsible for entering, processing, and analyzing the data was kept unaware of the group allocations (intervention vs. control). To ensure proper blinding, participants' data were coded anonymously, and the final dataset provided to the analyst contained no labels indicating group assignment. Additionally, the person responsible for extracting and interpreting outcome measures (e.g., caregiver burden and resilience scores) was also blinded to group assignment. Due to the behavioral nature of the intervention, it was not possible to blind the participants or the intervention provider. However, through blinding of the outcome assessor and data analyst, the risk of bias in analysis was minimized. N/A Attention Deficit Hyperactivity Disorder (ADHD). Intervention 1: Intervention Group: Mothers in the intervention group will be divided into groups of five, and groups will be formed for them in the Iranian application Eitaa. They will then receive Barkley’s educational sessions over 8 sessions, each lasting 1.5 hours, within one month. After each educational session, 3 to 4 questions will be administered as a quiz to ensure the mothers have learned the content. Additionally, discussions will take place in the Eitaa group regarding the session content .The session materials will be provided to participants in the form of podcasts, educational videos, and PowerPoint presentations. A summary of the session content, the objective of each educational session, and the assignments for each session are as follows:1. Session One :Objective: Change parents' perceptions of the disorder and problematic behaviors. Content: Explanation of the disorder, etiology, symptoms, common treatments, and identification of positive parenting methods .Assignment: Techniques for praise and attention.2. Session Two: Objective: Application of rewards and points. Content: Explanation of positive and differential reinforcement, identification of types of reinforcers in behavior management. Assignment: Completing a positive reinforcement table.3. Session Three: Objective: Learning techniques for encouragement and praise. Content: Teaching methods to increase desirable behaviors through praise techniques and reduce undesirable behaviors through reinforcement interruption. Assignment: Techniques for praise and reinforcement interruption.4. Session Four: Objective: Teaching parents behavioral management and behavior control, effective use of ignoring. Content: Training on positive attention to compliance with parental commands .Assignment: Tasks for paying attention and ignoring.5. Session Five :Objective: Improving child behavior at school, kindergarten, and home, and reducing aggressive behaviors .Content: Explanation of shaping specific behaviors by parents, using deprivation for risky and aggressive behaviors .Assignment: Techniques for punishment and deprivation.6. Session Six :Objective: Preventing severe misbehavior .Content: Developing a token economy program at home. Assignment: Using techniques for removing rewards and points.7. Session Seven: Objective: Reforming the mindset of parents who use punishment as the primary disciplinary method .Content: Application of corporal punishment. Assignment: Using submission, completing assignments (home-school communication), and summarizing learned content.8. Session Eight: Objective: Reviewing learned materials and correcting learning, managing future problems .Content: Summarizing learned content, teaching submission to problems. Assignment: Regularly completing assignments (home-school or kindergarten communication).After the first four sessions and then the last four sessions, two online sessions will be held on the Sky-room platform, where a child and adolescent psychologist will be present for mothers to ask their questions. The Zarit Caregiver Burden Scale and the Connor-Davidson Resilience Scale will be administered to mothers in the intervention group before the intervention starts, immediately after the intervention ends, and one month after the intervention concludes. Then, the results will be analyzed using SPSS software version 26. Intervention 2: Control Group: Mothers who are randomly assigned to the control group will not receive any specific educational intervention during the study and will only benefit from routine therapeutic care. The usual care includes periodic visits to a psychiatrist, monitoring the child's medication treatment, prescribing necessary medications at the physician's discretion, and receiving general therapeutic and supportive recommendations according to the current protocols of treatment centers (including psychiatric hospitals and relevant private clinics).In this group, no educational sessions, structured psychological counseling, or parenting training will be provided. Additionally, control group members will not have access to the educational content of the intervention, Sky-room sessions, or online groups (Eitaa) to prevent data contamination and ensure a valid comparison between the groups. To control for confounding variables, research tools including demographic questionnaires, the Zarit Caregiver Burden Scale, and the Connor-Davidson Resilience Scale will be administered at the same times and under equal conditions for both the intervention and control groups. These assessments will take place during the pre-test and post-test phases .Since providing an effective intervention to one group while completely depriving the other group could raise ethical concerns, at the end of the study, the complete content of Barkley’s cognitive-behavioral training provided to the intervention group (including files, podcasts, PowerPoints, and educational videos) will be made available to the control group in a summarized offline format. This action is in line with research fairness and adherence to ethical principles in research. Then, the results will be analyzed using SPSS software version 26. 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 Currently, there are no plans to publish individual participant data. Considering ethical considerations, data confidentiality requirements, and the lack of consent from participants for sharing personal information, there are currently no plans to release or share individual participant data (IPD).
public Parisa Rahmani
Shahid Dr. Kharazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Razavi Khorasan Province, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3884 6730 RahmaniP4033@mums.ac.ir Mashhad University of Medical Sciences scientific Naghme Razaghi
Shahid Dr. Kharazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Razavi Khorasan Province, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3884 6730 RazaghiN@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The mother has a child diagnosed with Attention Deficit Hyperactivity Disorder . (The official diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) should be made by a psychiatrist or clinical psychologist based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), or other valid diagnostic tools.) The mother is considered the primary caregiver of the child and holds all responsibilities for them. The mother has the physical and mental capacity to care for a child with Attention Deficit Hyperactivity Disorder (ADHD). The mother is interested in and willing to participate in the study. The mother is able to speak, read, and write in Persian The mother does not have an addiction to drugs or other psychoactive substances. The mother has not previously participated in family training sessions (other research in this area). The child should be aged between 6 to 9 years The child should not have any other debilitating conditions besides Attention Deficit Hyperactivity Disorder (ADHD), such as physical or mental disabilities, autism, etc. The child's GARS (Gilliam Autism Rating Scale) test result should be negative. (The GARS test is a definitive diagnostic tool for autism.) no limit no limit Female The mother suffers from a specific mental illness such as depression or bipolar disorder, which negatively affects her judgment, behavior, and cognitive functioning. The child's severe and uncontrollable behaviors resulting from hyperactivity are such that they have led to prolonged and frequent hospitalizations in the psychiatric emergency department, significantly disrupting the child's normal life. Lack of access to a smartphone or inability to use one by the mother. F90 Attention-deficit hyperactivity disorders Lifestyle Lifestyle Intervention Group: Mothers in the intervention group will be divided into groups of five, and groups will be formed for them in the Iranian application Eitaa. They will then receive Barkley’s educational sessions over 8 sessions, each lasting 1.5 hours, within one month. After each educational session, 3 to 4 questions will be administered as a quiz to ensure the mothers have learned the content. Additionally, discussions will take place in the Eitaa group regarding the session content .The session materials will be provided to participants in the form of podcasts, educational videos, and PowerPoint presentations. A summary of the session content, the objective of each educational session, and the assignments for each session are as follows:1. Session One :Objective: Change parents' perceptions of the disorder and problematic behaviors. Content: Explanation of the disorder, etiology, symptoms, common treatments, and identification of positive parenting methods .Assignment: Techniques for praise and attention.2. Session Two: Objective: Application of rewards and points. Content: Explanation of positive and differential reinforcement, identification of types of reinforcers in behavior management. Assignment: Completing a positive reinforcement table.3. Session Three: Objective: Learning techniques for encouragement and praise. Content: Teaching methods to increase desirable behaviors through praise techniques and reduce undesirable behaviors through reinforcement interruption. Assignment: Techniques for praise and reinforcement interruption.4. Session Four: Objective: Teaching parents behavioral management and behavior control, effective use of ignoring. Content: Training on positive attention to compliance with parental commands .Assignment: Tasks for paying attention and ignoring.5. Session Five :Objective: Improving child behavior at school, kindergarten, and home, and reducing aggressive behaviors .Content: Explanation of shaping specific behaviors by parents, using deprivation for risky and aggressive behaviors .Assignment: Techniques for punishment and deprivation.6. Session Six :Objective: Preventing severe misbehavior .Content: Developing a token economy program at home. Assignment: Using techniques for removing rewards and points.7. Session Seven: Objective: Reforming the mindset of parents who use punishment as the primary disciplinary method .Content: Application of corporal punishment. Assignment: Using submission, completing assignments (home-school communication), and summarizing learned content.8. Session Eight: Objective: Reviewing learned materials and correcting learning, managing future problems .Content: Summarizing learned content, teaching submission to problems. Assignment: Regularly completing assignments (home-school or kindergarten communication).After the first four sessions and then the last four sessions, two online sessions will be held on the Sky-room platform, where a child and adolescent psychologist will be present for mothers to ask their questions. The Zarit Caregiver Burden Scale and the Connor-Davidson Resilience Scale will be administered to mothers in the intervention group before the intervention starts, immediately after the intervention ends, and one month after the intervention concludes. Then, the results will be analyzed using SPSS software version 26. Control Group: Mothers who are randomly assigned to the control group will not receive any specific educational intervention during the study and will only benefit from routine therapeutic care. The usual care includes periodic visits to a psychiatrist, monitoring the child's medication treatment, prescribing necessary medications at the physician's discretion, and receiving general therapeutic and supportive recommendations according to the current protocols of treatment centers (including psychiatric hospitals and relevant private clinics).In this group, no educational sessions, structured psychological counseling, or parenting training will be provided. Additionally, control group members will not have access to the educational content of the intervention, Sky-room sessions, or online groups (Eitaa) to prevent data contamination and ensure a valid comparison between the groups. To control for confounding variables, research tools including demographic questionnaires, the Zarit Caregiver Burden Scale, and the Connor-Davidson Resilience Scale will be administered at the same times and under equal conditions for both the intervention and control groups. These assessments will take place during the pre-test and post-test phases .Since providing an effective intervention to one group while completely depriving the other group could raise ethical concerns, at the end of the study, the complete content of Barkley’s cognitive-behavioral training provided to the intervention group (including files, podcasts, PowerPoints, and educational videos) will be made available to the control group in a summarized offline format. This action is in line with research fairness and adherence to ethical principles in research. Then, the results will be analyzed using SPSS software version 26. The score obtained from the Connor-Davidson Resilience Scale questionnaire. Timepoint: Measuring the score obtained from the Connor-Davidson Resilience Scale questionnaire before the intervention, after the completion of the intervention, and one month after the completion of the intervention (follow-up). Method of measurement: The standard questionnaire of the Connor-Davidson Resilience Scale (2003). The score obtained from the Zarit Caregiver Burden Scale questionnaire. Timepoint: Measuring the score obtained from the Zarit Caregiver Burden Scale questionnaire before the intervention, after the completion of the intervention, and one month after the completion of the intervention (follow-up). Method of measurement: The Zarit Caregiver Burden Scale (1986). Mashhad University of Medical Sciences Approved 2025-04-22 Ethics Committee of the School of Nursing and Midwifery, Mashhad Shahid Dr. Kharazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Razavi Khorasan Province, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)