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IRCT20250315065082N1 IRCT 2025-05-05 Shiraz University of Medical Sciences Investigating the effect of parental behavioral training on improving the behavior of 6-12 year old children with attention deficit hyperactivity disorder Investigating the effect of SCT- based parental behavioral training on improving the behavior of 6-12- year- old children with attention deficit- hyperactivity disorder; A randomized controlled trial 2025-05-03 anticipated 50 Complete https://irct.ir/trial/82664 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: -, Randomization description: In this study, we will use the permutation block method to randomly assign participants (parents of hyperactive children) to two control and comparison groups. First, a list of all participants is prepared (50 people). Then, the parents are divided into blocks such that each block contains a certain number of participants. In this study, the size of each block is set to 4 (2 people for the control group and 2 people for the comparison group). NCSS-PASS version 15 software is used to create random sequences. In each block, all possible combinations for assigning participants to two groups (control and comparison) will be listed. One sequence is randomly selected from among the permutation sequences. Participants are assigned to blocks based on the selected random sequence and are assigned to one of the two control and comparison groups. N/A Attention-deficit hyperactivity disorder. Intervention 1: In the first session: A class for educational intervention will be held at Imam Reza Clinic. Initially, after familiarization, questionnaires will be distributed and collected, and the disease of attention deficit/hyperactivity disorder and the importance of the disease in improving children's behavior will be explained to increase the knowledge structure for 60 minutes using interactive lectures, questions and answers, and PowerPoint educational media and educational clips. In the second session: After reviewing the points of the previous session and announcing the results of the questionnaire, the characteristics and symptoms of the disease, the definition of attention and concentration, the strategy for increasing attention and concentration in order to increase the knowledge structure will be done for 60 minutes using the brainstorming method, interactive lectures, PowerPoint educational media, educational clips, and brochures. In the third session: After reviewing the points of the previous sessions, a description of the principles of behavior change at home and school in order to increase the knowledge structure and improve and change the self-control structure will be done for 60 minutes using interactive lectures, group discussions, PowerPoint educational media, and educational clips. In the fourth session: After reviewing the points of the previous sessions, the treatment of attention deficit/hyperactivity disorder including (drug therapy and behavioral therapy) and the importance of Behavior therapy will be conducted for 60 minutes using interactive lectures and questions and answers, with the help of PowerPoint educational media and educational clips. In the fifth session: After reviewing the points of the previous sessions on the impact of parental behavior and the family system on the treatment process and teaching appropriate behavior between parents and children and the appropriate communication between parents in order to increase the two knowledge structures and self-efficacy, it will be conducted for 60 minutes using interactive lectures and group discussions, with the help of PowerPoint educational media and educational clips. In the sixth session: After reviewing the points of the previous sessions, by defining parenting styles and defining reinforcement patterns (positive reinforcement and negative reinforcement) in order to change the outcome expectation structure for 60 minutes, parents will also be taught the 14 guiding principles for raising children with ADHD in sessions 6 and 7 using interactive lectures and questions and answers, with the help of PowerPoint educational media, educational clips and brochures. In the seventh session: After reviewing the points of the previous sessions, relaxation techniques for parents will be taught for 60 minutes using practical demonstrations and PowerPoint educational media and educational clips. In the eighth session: In this session, by summarizing the material, the success of the program will be examined for 60 minutes using group discussion and PowerPoint media with the aim of resolving problems and answering ambiguities. The educational content has been prepared from reliable sources such as the book Managing the Behavior of Hyperactive Children by Rossella Barclay, which was mentioned in the study. No pharmaceutical, chemical, etc. interventions will be used in this plan. Intervention 2: Control group: Control group: Initially, after the control group completes the existing questionnaires, this group will proceed according to the educational protocol they receive from the clinic's pediatric psychiatrist. At the end of the intervention, we will provide the control group with the educational content that was taught to the intervention group. 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 I need to consult with my supervisor.
public mohadeseh mardaneh
Zand Street, opposite Palestine Street, Shiraz University of Medical Sciences Central Building
Shiraz Iran (Islamic Republic of) 71348-14336 +98 901 644 4842 m.mardane_74@yahoo.com Shiraz University of Medical Sciences scientific Dr. Mohammad Hossein Kaveh
Zand Street, opposite Palestine Street, Shiraz University of Medical Sciences Central Building
Shiraz Iran (Islamic Republic of) 71348-14336 +98 901 644 4842 mhkaveh255@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The child being studied must be at least 6 years old and no more than 12 years old The child's attention deficit hyperactivity disorder has been confirmed by the clinic's psychiatrist The child's parents (at least the mother) must give their consent to participate in the study The child's parents (at least the mother) must be at least literate (end of third grade of primary school) The child under study should not have severe physical or motor disabilities or severe hearing or visual impairments The child and his/her parents (at least the mother) are not participating in an educational program similar to the one that will be implemented in this project The affected child is under the direct care of the parents (mother, father, or both) At least 3 months have passed since the child was diagnosed and started treatment 6 years 12 years Both The child under study has severe physical-motor disabilities or severe hearing and visual impairments. The child being studied has a specific disease, such as diabetes, that requires special care. The native language of the child being studied is other than Persian. F90 Attention-deficit hyperactivity disorders Behavior Behavior In the first session: A class for educational intervention will be held at Imam Reza Clinic. Initially, after familiarization, questionnaires will be distributed and collected, and the disease of attention deficit/hyperactivity disorder and the importance of the disease in improving children's behavior will be explained to increase the knowledge structure for 60 minutes using interactive lectures, questions and answers, and PowerPoint educational media and educational clips. In the second session: After reviewing the points of the previous session and announcing the results of the questionnaire, the characteristics and symptoms of the disease, the definition of attention and concentration, the strategy for increasing attention and concentration in order to increase the knowledge structure will be done for 60 minutes using the brainstorming method, interactive lectures, PowerPoint educational media, educational clips, and brochures. In the third session: After reviewing the points of the previous sessions, a description of the principles of behavior change at home and school in order to increase the knowledge structure and improve and change the self-control structure will be done for 60 minutes using interactive lectures, group discussions, PowerPoint educational media, and educational clips. In the fourth session: After reviewing the points of the previous sessions, the treatment of attention deficit/hyperactivity disorder including (drug therapy and behavioral therapy) and the importance of Behavior therapy will be conducted for 60 minutes using interactive lectures and questions and answers, with the help of PowerPoint educational media and educational clips. In the fifth session: After reviewing the points of the previous sessions on the impact of parental behavior and the family system on the treatment process and teaching appropriate behavior between parents and children and the appropriate communication between parents in order to increase the two knowledge structures and self-efficacy, it will be conducted for 60 minutes using interactive lectures and group discussions, with the help of PowerPoint educational media and educational clips. In the sixth session: After reviewing the points of the previous sessions, by defining parenting styles and defining reinforcement patterns (positive reinforcement and negative reinforcement) in order to change the outcome expectation structure for 60 minutes, parents will also be taught the 14 guiding principles for raising children with ADHD in sessions 6 and 7 using interactive lectures and questions and answers, with the help of PowerPoint educational media, educational clips and brochures. In the seventh session: After reviewing the points of the previous sessions, relaxation techniques for parents will be taught for 60 minutes using practical demonstrations and PowerPoint educational media and educational clips. In the eighth session: In this session, by summarizing the material, the success of the program will be examined for 60 minutes using group discussion and PowerPoint media with the aim of resolving problems and answering ambiguities. The educational content has been prepared from reliable sources such as the book Managing the Behavior of Hyperactive Children by Rossella Barclay, which was mentioned in the study. No pharmaceutical, chemical, etc. interventions will be used in this plan. Control group: Control group: Initially, after the control group completes the existing questionnaires, this group will proceed according to the educational protocol they receive from the clinic's pediatric psychiatrist. At the end of the intervention, we will provide the control group with the educational content that was taught to the intervention group. Children's behavior. Timepoint: Measuring children's behavior once before the start of the study and once one to two months after the intervention. Method of measurement: Connors Parent Hyperactivity Questionnaire. -Knowledge: Learning facts and gaining insight related to an action, idea, object, person, or situation; information and facts about a subject. Timepoint: Primary outcome measurements once before the start of the study and one to two months after the intervention. Method of measurement: -Researcher-made questionnaire. Outcome expectations refer to the value that an individual places on the possible outcomes of performing a behavior. Timepoint: Primary outcome measurements once before the start of the study and one to two months after the intervention. Method of measurement: -Researcher-made questionnaire. Self-efficacy: confidence in one's ability to follow a behavior (confidence in behavior). Timepoint: Primary outcome measurements once before the start of the study and one to two months after the intervention. Method of measurement: Researcher-made questionnaire. Goal setting or self-control: setting goals and planning to carry out chosen behaviors (goal setting). Timepoint: Primary outcome measurements once before the start of the study and one to two months after the intervention. Method of measurement: -Researcher-made questionnaire. Emotional coping: Techniques a person uses to control emotional and physiological states. Timepoint: Primary outcome measurements once before the start of the study and one to two months after the intervention. Method of measurement: -Researcher-made questionnaire. Shiraz University of Medical Sciences Approved 2025-03-04 Ethics Committee of Shiraz University of Medical Sciences Zand Street Shiraz Fars Iran (Islamic Republic of)