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IRCT20200107046044N9 IRCT 2025-12-14 Yasouj University of Medical Sciences Effect of an artificial intelligence-based self-management educational intervention on the empowerment and resilience Effect of anartificial intelligence-based self-management educational intervention on the empowerment and resilience of mothers with children suffering from attention deficit/hyperactivity disorder (ADHD): A randomized controlled clinical trial 2026-01-21 anticipated 100 Complete https://irct.ir/trial/87692 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible study participants will be selected through convenience sampling and randomly assigned to one of the two groups (intervention and control) using block randomization. Two-group blocks of sizes 2, 4, and 6 will be utilized. For example, when the block size is 2, the possible sequences are AB and BA (where A and B represent the intervention and control groups, respectively). An online platform will be used to generate the allocation sequence and ensure concealment. A dedicated randomization code will be generated, and a block randomization allocation list will be prepared. After fully explaining the study objectives, eligible participants will be assigned a unique code according to the order of their referral. By matching this code with the block randomization allocation list, participants will be allocated to either the intervention or control group. This process will continue until the estimated sample size is achieved. N/A Attention Deficit/Hyperactivity Disorder (ADHD). Intervention 1: Intervention group: In this group, interventions will be conducted according to the protocol, summarized in 10 sessions as outlined below:Session 1: Introduction of participants, brief overview of the 10 sessions, and instruction on how to use artificial intelligence tools.Session 2: Introduction to the concept of self-management, understanding Attention-Deficit/Hyperactivity Disorder (ADHD) and its symptoms.Session 3: Training in mother–child principles and interactive mother–child play, identifying stressors, basic stress-reduction techniques, and practicing simple relaxation techniques.Session 4: Cognitive flexibility through the “Hearts and Flowers” game, introduction to the concept of resilience, familiarity with the SMART technique for goal setting, and formulation of short-term and long-term goals.Session 5: Cognitive flexibility through the “Cards” game, introduction to service systems, principles of time management, creation of daily and weekly schedules, and techniques for overcoming procrastination.Session 6: Cognitive flexibility through the “Quadrato” game, introduction to social-political systems, recognition of emotions and their impact on behavior, strategies for anger management and emotional control, and practicing healthy emotional expression.Session 7: Enhancement of executive functions, including working memory, through the “Tapping” game; cognitive flexibility through the “Knuckle-Shoulder-Knee” game; importance of self-care for mothers; physical and psychological self-care methods; and planning daily and weekly activities to maintain mental health.Session 8: Enhancement of executive functions, including working memory, through the “Inside and Outside” game; cognitive flexibility through the “Rush Hour” game; problem-solving stages; logical decision-making techniques; and practice with sample problems and appropriate solutions.Session 9: Enhancement of executive functions, including working memory, through the “Locking” game; cognitive flexibility through the “Shape and Color” game; practical strategies for managing challenging behaviors; and collaboration with teachers and specialists.Session 10: Review of experiences and overall conclusions.Following the sessions, telephone follow-ups will be conducted to monitor the completion of home exercises. Interventions, once taught by the researcher, will be carried out individually by participants at home. The 10 sessions will each last 50 minutes, conducted twice weekly over a total of 5 weeks, in line with similar studies.Prior to the intervention, artificial intelligence tools, including ChatGPT, will be introduced to participants by the researcher. The researcher will provide complete instructions on using these tools, including initial training, guidance, and troubleshooting technical issues. Thus, in case of any questions, participants will consult only these AI tools to obtain answers. The intervention protocol itself will also be selected and implemented using the aforementioned AI tools. Intervention 2: Control group: non-intervention; There will be no intervention in this 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 There is no further information.
public MohammadSajjad Mousavi
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
Bandar-e-Mahshahr Iran (Islamic Republic of) 6354169401 +98 61 5242 1065 sajjad.mousavi2512@gmail.com Ahvaz University of Medical Sciences scientific MohammadSajjad Mousavi
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
Bandar-e-Mahshahr Iran (Islamic Republic of) 6354169401 +98 61 5242 1065 sajjad.mousavi2512@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) The ability to communicate and respond to questions Being between 25 and 45 years of age Having a child aged 6–12 years Willingness to participate in the study and signing the informed consent form A definitive diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) in the child by a relevant specialist physician Simultaneously obtaining a score of 102 or lower on the Koren et al.'s Family Empowerment Scale (FES) and a score of 20 or lower on the Connor-Davidson Resilience scale-10 (CD-RISC-10) 25 years 45 years Female Prior training and participation in studies similar to the current research within the past six months Presence of a severe or disabling psychiatric disorder in the mother that would prevent effective participation in the intervention (e.g., severe psychiatric disorders, schizophrenia, acute bipolar disorder). Significant changes in the child’s condition (e.g., receiving new treatments or major medication changes) Having marital conflicts Having mood and emotional disorders Using narcotic substances F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Lifestyle Lifestyle Intervention group: In this group, interventions will be conducted according to the protocol, summarized in 10 sessions as outlined below:Session 1: Introduction of participants, brief overview of the 10 sessions, and instruction on how to use artificial intelligence tools.Session 2: Introduction to the concept of self-management, understanding Attention-Deficit/Hyperactivity Disorder (ADHD) and its symptoms.Session 3: Training in mother–child principles and interactive mother–child play, identifying stressors, basic stress-reduction techniques, and practicing simple relaxation techniques.Session 4: Cognitive flexibility through the “Hearts and Flowers” game, introduction to the concept of resilience, familiarity with the SMART technique for goal setting, and formulation of short-term and long-term goals.Session 5: Cognitive flexibility through the “Cards” game, introduction to service systems, principles of time management, creation of daily and weekly schedules, and techniques for overcoming procrastination.Session 6: Cognitive flexibility through the “Quadrato” game, introduction to social-political systems, recognition of emotions and their impact on behavior, strategies for anger management and emotional control, and practicing healthy emotional expression.Session 7: Enhancement of executive functions, including working memory, through the “Tapping” game; cognitive flexibility through the “Knuckle-Shoulder-Knee” game; importance of self-care for mothers; physical and psychological self-care methods; and planning daily and weekly activities to maintain mental health.Session 8: Enhancement of executive functions, including working memory, through the “Inside and Outside” game; cognitive flexibility through the “Rush Hour” game; problem-solving stages; logical decision-making techniques; and practice with sample problems and appropriate solutions.Session 9: Enhancement of executive functions, including working memory, through the “Locking” game; cognitive flexibility through the “Shape and Color” game; practical strategies for managing challenging behaviors; and collaboration with teachers and specialists.Session 10: Review of experiences and overall conclusions.Following the sessions, telephone follow-ups will be conducted to monitor the completion of home exercises. Interventions, once taught by the researcher, will be carried out individually by participants at home. The 10 sessions will each last 50 minutes, conducted twice weekly over a total of 5 weeks, in line with similar studies.Prior to the intervention, artificial intelligence tools, including ChatGPT, will be introduced to participants by the researcher. The researcher will provide complete instructions on using these tools, including initial training, guidance, and troubleshooting technical issues. Thus, in case of any questions, participants will consult only these AI tools to obtain answers. The intervention protocol itself will also be selected and implemented using the aforementioned AI tools. Control group: non-intervention; There will be no intervention in this group. The Empowerment score is derived from the Koren et al.'s Family Empowerment Scale (FES). Timepoint: Before the implementation of the interventions and one month after the completion of the interventions. Method of measurement: Koren et al.'s Family Empowerment Scale (FES). The Resilience score is derived from the Connor-Davidson Resilience scale-10 (CD-RISC-10). Timepoint: Before the implementation of the interventions and one month after the completion of the interventions. Method of measurement: Connor-Davidson Resilience scale-10 (CD-RISC-10). Yasouj University of Medical Sciences Approved 2025-11-19 Ethics committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)