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# Registration date Revision Id
2 2025-04-09, 1404/01/20 336202
1 2023-12-09, 1402/09/18 287874
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  • Protocol summary

    Investigating the effectiveness of the smart phone application for teaching self-care activities in improving the self-care performance of children with autism spectrum disorder and their parents' participation in rehabilitation
    Investigating the effectiveness of the therapist-managed smartphone application for teaching self-care activities in improving the self-care performance of children with autism spectrum disorder, their parents' participation in rehabilitation, and parent's psychosocial state
    بررسی اثربخشی اپلیکیشن گوشی تلفن همراه هوشمند آموزش فعالیت‌های خودمراقبتی در بهبود عملکرد خودمراقبتی کودکان با اختلال طیف اتیسم و مشارکت والدین آن‌ها در توانبخشی
    بررسی اثربخشی اپلیکیشن گوشی تلفن همراه هوشمند آموزش فعالیت‌های خودمراقبتی در بهبود عملکرد خودمراقبتی کودکان با اختلال طیف اتیسم، مشارکت والدین آن‌ها در توانبخشی، و وضعیت روانشناختی والدین
    A single-blind clinical trial with two groups of control and intervention-sampling will be conducted with randomization by the method of blocks of four. The sample size will be obtained through a pilot study.
    Single-blind (examiner) two-arm parallel randomized controlled trial (RCT), with a four-block randomization method. The sample size was considered as 30 children with ASD and their primary caregiver.
    کارازمایی بالیی یک سوکور و با دوگروه کنترل و مداخله-نمونه‌گیری با تصادفی‌سازی به روش بلوک‌های چهارتایی انجام خواهد گرفت. از بین بلوک‌های چهارتایی ممکن، نمونه گرفته خواهد شد و تا زمان تکمیل نمونه‌ها، بین دو گروه کنترل و مداخله تخصیص داده خواهند شد. حجم نمونه با مطالعه ی پایلوت به دست خواهد آمد.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده با روش بلوکهای چهارتایی. حجم نمونه 30 کودک با اختلال طیف اتیسم و مراقب اصلی آنها است.
    o Having an ASD diagnosis by a child psychiatrist o The severity of autism according to the GARS test is level 1 or 2 o Being a child in the age range of 5 to 12 years o According to COPM, difficulty in performing at least three self-care activities is among the main complaints of the family about the child o Being a child under occupational therapy so that self-care goals are pursued by the occupational therapist through common interventions. o Ability to pay attention to images or videos on the screen for at least five minutes based on parent report o Obtaining a score above 16 in MIS in order to have the minimum ability to imitate in the use of VM
    Inclusion criteria: Having an ASD diagnosis by a child psychiatrist; The severity of autism according to the GARS test is level 1 or 2; Being a child in the age range of 5 to 12 years; According to COPM, difficulty in performing at least three self-care activities is among the main complaints of the family about the child; Being a child under occupational therapy so that self-care goals are pursued by the occupational therapist through common interventions; Ability to pay attention to images or videos on the screen for at least five minutes based on parent report; Obtaining a score above 16 in MIS in order to have the minimum ability to imitate in the use of VM; not having behavioral issues in the child based on the CSI-4
    o داشتن تشخیص ASD توسط روان‌پزشک کودک o شدت اتیسم برحسب آزمون GARS در سطح 1 یا 2 باشد o قرار داشتن کودک در دامنه سنی 5 تا 12 سال o بر اساس COPM، مشکل در انجام حداقل سه فعالیت خودمراقبتی جزو شکایات اصلی خانواده در مورد کودک باشد o بودن کودک تحت کاردرمانی به‌طوری که اهداف خودمراقبتی توسط کاردرمانگر از طریق مداخلات رایج پیگیری ‌شود o توانایی توجه به تصاویر یا فیلم روی صفحه‌ی نمایشگر به مدت حداقل پنج دقیقه بر اساس گزارش والدین o کسب نمره‌ی بالای 16 در MIS به منظور داشتن توانایی حداقلی تقلید لازم در استفاده از VM (46)
    شرایط ورود: داشتن تشخیص ASD توسط روان‌پزشک کودک؛ شدت اتیسم برحسب آزمون GARS در سطح 1 یا 2 باشد،؛ قرار داشتن کودک در دامنه سنی 5 تا 12 سال؛ بر اساس COPM، مشکل در انجام حداقل سه فعالیت خودمراقبتی جزو شکایات اصلی خانواده در مورد کودک باشد؛ بودن کودک تحت کاردرمانی به‌طوری که اهداف خودمراقبتی توسط کاردرمانگر از طریق مداخلات رایج پیگیری ‌شود؛ توانایی توجه به تصاویر یا فیلم روی صفحه‌ی نمایشگر به مدت حداقل پنج دقیقه بر اساس گزارش والدین؛ کسب نمره‌ی بالای 16 در MIS به منظور داشتن توانایی حداقلی تقلید لازم در استفاده از VM ؛ عدم وجود مشکلات رفتاری در کودک براساس ابزار CSI-4
    In this study, the control group will receive routine occupational therapy services for children with ASD delivered by an occupational therapist. The intervention group will receive the self-care activity training application to be used and practiced at home under the supervision of the therapist and researcher.
    In this study, the control group will receive live modeling by the main caregiver at home.The intervention group will receive the self-care activity training application to be used and practiced at home under the supervision of the therapist and researcher.
    در این مطالعه گروه کنترل درمان روتین خدمات کاردرمانی برای کودکان با ASD را که توسط کاردرمانگر در حال انجام است دریافت خواهند کرد که به طور معمول شامل رویکردهای یکپارچگی حسی، رفتاری، و تکاملی است. گروه مداخله، اپلیکیشن آموزش فعالیت های خودمراقبتی را دریافت خواهد کرد تا در منزل با نظارت درمانگر و محقق، استفاده و تمرین گردد.
    در این مطالعه گروه کنترل الگودهی زنده توسط مراقب اصلی را در منزل دریافت خواهند کرد. گروه مداخله، اپلیکیشن آموزش فعالیت های خودمراقبتی را دریافت خواهد کرد تا در منزل با نظارت درمانگر و محقق، استفاده و تمرین گردد.
    application; self-care performance; participation
    Application; self-care performance; family functioning in rehabilitation, parent's psychosocial status
    اپلیکیشن؛ عملکرد در فعالیت‌های خودمراقبتی؛ مشارکت
    اپلیکیشن؛ عملکرد در فعالیت‌های خودمراقبتی؛ مشارکت خانواده در توانبخشی،‌ وضعیت روانشناختی مراقبین
  • General information

    Single
    Parallel
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    31
    2024-05-21, 1403/03/01
    2024-07-22, 1403/05/01
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    2024-04-20, 1403/02/01
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    2024-08-20, 1403/05/30
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    2025-11-21, 1404/08/30
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    After implementing a pilot study of the using application, some changes seemed to be required to have a more concise results.
    empty
    پس از انجام مطالعه پایلوت برای یافتن خطاهای احتمالی اپلیکیشن و بررسی اولیه روش اجرای کارازمایی بالینی،‌ یک سری از تغییرات مشاهده گردید تا نتایج به بهترین شیوه ممکن اجرا گردد.
    Investigating effectiveness of the smartphone application of training self-care activities on self-care performance of children with autism spectrum disorder and their parents’ participation in rehabilitation
    Investigating effectiveness of the smartphone application of training self-care activities on self-care performance of children with autism spectrum disorderو their parents’ participation in rehabilitation and psychological state
    بررسی اثربخشی اپلیکیشن آموزش فعالیت‌های خودمراقبتی بر عملکرد خودمراقبتی کودکان با اختلال طیف اتیسم و مشارکت والدین آن‌ها در توانبخشی
    بررسی اثربخشی اپلیکیشن آموزش فعالیت‌های خودمراقبتی بر عملکرد خودمراقبتی کودکان با اختلال طیف اتیسم، مشارکت والدین آن‌ها در توانبخشی، و وضعیت روانشناختی والدین
    Investigating effectiveness of the smartphone application of training self-care activities on self-care performance of children with autism spectrum disorder and their parents’ participation in rehabilitation
    Investigating effectiveness of the therapist-managed self-care training smartphone application based on video-modeling for children with autism spectrum disorder and their parents
    بررسی اثربخشی اپلیکیشن آموزش فعالیت‌های خودمراقبتی بر عملکرد خودمراقبتی کودکان با اختلال طیف اتیسم و مشارکت والدین آن‌ها در توانبخشی
    بررسی اثربخشی اپلیکیشن آموزش فعالیت‌های خودمراقبتی با مدیریت درمانگر بر عملکرد خودمراقبتی کودکان با اختلال طیف اتیسم، و والدین آن‌ها
    Having an ASD diagnosis by a child psychiatrist
    The severity of autism according to the GARS test is level 1 or 2
    Being a child in the age range of 5 to 12 years
    According to COPM, difficulty in performing at least three self-care activities is among the main complaints of the family about the child
    Participating in occupational therapy sessions so that self-care goals are pursued by the occupational therapist through common interventions.
    Ability to pay attention to images or videos on the screen for at least five minutes based on parent report
    Obtaining a score above 16 in MIS in order to have the minimum imitation ability necessary to use VM
    Having an ASD diagnosis by a child psychiatrist
    The severity of autism according to the GARS-3 test is level 1 or 2
    Being a child in the age range of 5 to 12 years
    According to COPM, difficulty in performing at least three self-care activities is among the main complaints of the family about the child
    Participating in occupational therapy sessions so that self-care goals are pursued by the occupational therapist through common interventions.
    Ability to pay attention to images or videos on the screen for at least five minutes based on parent report
    Obtaining a score above 16 in MIS in order to have the minimum imitation ability necessary to use VM
    Not having behavioral issues in the child based on the child symptom inventory version 4 (CSI-4) with the subscales of attention deficit hyperactivity disorder, oppositional defiant disorder, and conduct disorder (ADHD, ODD, CD)
    The ability to read and write in parents of children
    Having an android-based smartphone
    داشتن تشخیص ASD توسط روان‌پزشک کودک
    شدت اتیسم برحسب آزمون GARS در سطح 1 یا 2 باشد
    قرار داشتن کودک در دامنه سنی 5 تا 12 سال
    بر اساس COPM، مشکل در انجام حداقل سه فعالیت خودمراقبتی جزو شکایات اصلی خانواده در مورد کودک باشد
    بودن کودک تحت کاردرمانی به‌طوری که اهداف خودمراقبتی توسط کاردرمانگر از طریق مداخلات رایج پیگیری ‌شود
    توانایی توجه به تصاویر یا فیلم روی صفحه‌ی نمایشگر به مدت حداقل پنج دقیقه بر اساس گزارش والدین
    کسب نمره‌ی بالای 16 در MIS به منظور داشتن توانایی حداقلی تقلید لازم در استفاده از VM
    دارا بودن سواد خواندن و نوشتن
    داشتن گوشی تلفن همراه هوشمند با سسیستم عامل اندروئیدی و توانایی استفاده از آن
    اعلام آمادگی برای مشارکت فعال در کاربرد اپلیکیشن آموزش فعالیت‌های خودمراقبتی
    داشتن تشخیص ASD توسط روان‌پزشک کودک
    شدت اتیسم برحسب آزمون GARS در سطح 1 یا 2 باشد
    قرار داشتن کودک در دامنه سنی 5 تا 12 سال
    بر اساس COPM، مشکل در انجام حداقل سه فعالیت خودمراقبتی جزو شکایات اصلی خانواده در مورد کودک باشد
    بودن کودک تحت کاردرمانی به‌طوری که اهداف خودمراقبتی توسط کاردرمانگر از طریق مداخلات رایج پیگیری ‌شود
    توانایی توجه به تصاویر یا فیلم روی صفحه‌ی نمایشگر به مدت حداقل پنج دقیقه بر اساس گزارش والدین
    کسب نمره‌ی بالای 16 در MIS به منظور داشتن توانایی حداقلی تقلید لازم در استفاده از VM
    دارا بودن سواد خواندن و نوشتن
    داشتن گوشی تلفن همراه هوشمند با سسیستم عامل اندروئیدی و توانایی استفاده از آن
    عدم وجود مشکلات رفتاری در کودک براساس مقیاس CSI-4 و زیر آیتم های ADHD, CD, ODD
    o Existence of seizures and severe medical problems in the child based on the medical record or as reported by the parents
    Implementation of self-care intervention through VM in the child's current treatment plan
    Anxiety, stress and depression scores above the cutoff point in DASS-21 in the primary caregiver
    Having a physical problem in the main caregiver
    Existence of seizures and severe medical problems in the child based on the medical record or as reported by the parents
    Implementation of self-care intervention through VM in the child's current treatment plan
    Having a physical problem in the main caregiver
    وجود تشنج و مشکلات پزشکی شدید در کودک بر اساس پرونده پزشکی یا به گزارش والدین
    اجرای مداخله خودمراقبتی از طریق VM در برنامه درمانی فعلی کودک
    نمره اضطراب، استرس و افسردگی بالاتر از نقطه برش در DASS-21 در مراقب اصلی
    داشتن مشکل فیزیکی در مراقب اصلی
    وجود تشنج و مشکلات پزشکی شدید در کودک بر اساس پرونده پزشکی یا به گزارش والدین
    اجرای مداخله خودمراقبتی از طریق VM در برنامه درمانی فعلی کودک
    داشتن مشکل فیزیکی در مراقب اصلی
  • Health conditions studied

    #1
    autism spectrum disorder
    Autism spectrum disorder
  • Primary outcomes

    #1
    Performance in self-care activities refers to the ability to perform activities that a person uses to protect his physical and mental health and meet the basic needs of his daily life (44).In this research, there are one to five functional problems in the implementation of self-care activities, which will be selected as intervention goals with the cooperation of the caregiver and the therapist through COPM. These activities can include combing hair, wearing socks, wearing shorts, wearing pants, zipping pants, brushing teeth, wearing a sweatshirt, wearing a t-shirt, going to the bathroom, washing hands and face, eating, taking a bath, and putting on shoes. Changes in the child's ability will be measured through the Canadian Occupational Performance Scale (COPM), the Goal Achievement Scale (GAS), and the Activities of Daily Living Inventory for Children with Disabilities (ADLIC-D).
    self-care performance
    عملکرد در فعالیت‌های خودمراقبتی :تعريف شرحي: عملکرد در فعالیت‌های خودمراقبتی به توانایی انجام فعالیت‌هایی اطلاق می‌شود که فرد با استفاده از آن‌ها از سلامت جسم و روان خود محافظت می‌نماید و نیازهای اساسی زندگی روزمره‌ی خود را مرتفع می‌سازد (44). تعريف کاربردی: در این پژوهش عبارت است از یک تا پنج مشکل عملکردی در اجرای فعالیت‌های خودمراقبتی که با همکاری مراقب و درمانگر از طریق COPM به عنوان اهداف مداخله انتخاب خواهند شد. این فعالیت‌ها می توانند شامل شانه کردن مو، پوشیدن جوراب، پوشیدن شورت، پوشیدن شلوار، بستن زیپ شلوار، مسواک زدن، پوشیدن سوییشرت، پوشیدن تیشرت، دستشویی رفتن، شستن دست و صورت، غذا خوردن، حمام رفتن، و پوشیدن کفش باشند که تغییرات در توانایی کودک از طریق "مقیاس کانادایی عملکرد کاری" (COPM )، "مقیاس دستیابی به اهداف" (GAS ) و "فهرست فعالیت‌های زندگی روزمره برای کودکان با ناتوانی" (ADLIC-D ) اندازه‌گیری خواهد شد.
    عملکرد خودمراقبتی
    before the start of the intervention, 2 months, and three months after the start of the intervention
    before intervention, immediately after the intervention, and one month after the end of intervention
    قبل از شروع مداخله، 2 ماه، و سه ماه بعد از شروع مداخله
    قبل از شروع مداخله، بلافاصله بعد مداخله، و یک ماه بعد اتمام مداخله
    Activities of Daily Living Inventory for Children with Disabilities; (COPM) Canadian Occupational Performance Measure; (GAS) Goal Attainment Scale
    Activities of Daily Living Inventory for Children with Disabilities (ADLIC-D); Canadian Occupational Performance Measure (COPM); Goal Attainment Scale (GAS)
  • Secondary outcomes

    #1
    participation
    Family functioning in rehabilitation
    مشارکت
    مشارکت خانواده در توانبخشی
    Before the intervention, two and three months after the intervention
    Before the intervention, immediately after the intervention, one month after the end of intervention
    قبل مداخله، دو و سه ماه شروع مداخله
    قبل مداخله، بلافاصله بعد مداخله و یک ماه بعد اتمام مداخله
    #2
    empty
    Depression, anxiety, and stress of parents of children
    empty
    افسردگی،‌اضطراب، و استرس والدین کودکان با اختلال طیف اتیسم
    empty
    Before the intervention, immediately after the intervention, one month after the end of intervention
    empty
    قبل مداخله، بلافاصله بعد مداخله و یک ماه بعد اتمام مداخله
    empty
    Depression, anxiety, stress sacle-42 items (DASS-42)
    empty
    مقیاس افسردگی،‌ اضطراب، و استرس 42 آیتمی
  • Intervention groups

    #1
    Intervention group: In the intervention group, the first step is to install the app on the caregiver's smart phone and teach how to use it. In this training, the caregiver is asked to perform at least two activities that can be performed in the center under the supervision of the researcher, so that possible problems can be fixed and the necessary points are given feedback. In order to ensure the correctness and integrity of the training process by parents, in addition to the instruction section inside the application, a guidance sheet will also be provided to parents, the contents of which will be as follows: o While watching movies, it is better not to talk to the child (avoid giving verbal guidance) so that he can keep all his attention on the video instruction. The main caregiver can only use minimal physical guidance to the extent of helping the child to understand more about the correct implementation of the correct movement pattern of the desired activity.o The primary caregiver can use a cue or symbol that is familiar and meaningful to their child as an associator of the intended target activity (such as "beh beh" or "hum hum" to evoke the activity of eating) to prepare the child.o As much as possible, the training time should be in the time period close to the actual performance of that activity and based on the daily routine of that activity in a way that does not cause the child's anxiety and panic. o If according to the child's routine, the desired activity or assignment is such that it may not occur at least once during the day, create a simulator or artificial situation and practice at least once a day.o If the child does not pay attention to a part of the video or is distracted, the primary caregiver can use the repeat option to show the stage or stages of the target activity again until the child watches the videos with proper attention. Otherwise, do not use the repeat option.o It is preferable to avoid using the application when the child's attention and concentration are not suitable.o Do not use the application after taking sleeping pills. o After fully viewing all the videos related to the steps of a particular activity, the child will look at the steps step by step and after completing each step, the mother will choose the correct qualitative option and then after receiving appropriate visual feedback depending on the quality of doing it Step enters the next step.o All the steps related to a particular activity should be done in one go without a break of more than 5 seconds between the steps of the activity.o In case of three consecutive records of independently performing all steps of an activity, the caregiver can no longer use the application to perform that activity.o Avoid showing videos and applications on TV, tablets or other platforms with larger frames. Then the researcher will make the activities determined in the COPM accessible in the carer application. Caregivers will practice at home based on the training provided by the researcher and follow the guidelines and record the quality of the steps in the application. After entering the section dedicated to him in the application, the therapist will monitor the quality of the selected task that the parents mark with three options: "independent", "with help", and "dependent". . The communication between the caregiver and the researcher will be done through the messaging section of the application and in the form of sending video or voice and text messages. During the intervention period, each caregiver can ask a maximum of three questions so that the response frequency is the same in all samples of the intervention group. Once every two weeks through a video call or sending a video on the platform of the training and practice of the caregiver with the child at home, monitoring the performance of the parents or online under supervision learning will be done, so that possible errors in the implementation and training of the parents will be given feedback. In case of three consecutive records of independently performing all steps of an activity, the caregiver can no longer use the application to perform that activity.The intervention process will be implemented for two months on the intervention group.
    Intervention group: In the intervention group, the first step is to install the app on the caregiver's smart phone and teach how to use it. In this training, the caregiver is asked to perform at least two activities that can be performed in the center under the supervision of the researcher, so that possible problems can be fixed and the necessary points are given feedback. In order to ensure the correctness and integrity of the training process by parents, in addition to the instruction section inside the application, a video record of app instruction will also be provided to parents. Also, in the app itself there is a guide section consistin the following sentences: The main caregiver can only use minimal physical guidance to the extent of helping the child to understand more about the correct implementation of the correct movement pattern of the desired activity.o The primary caregiver can use a cue or symbol that is familiar and meaningful to their child as an associator of the intended target activity (such as "beh beh" or "hum hum" to evoke the activity of eating) to prepare the child.o As much as possible, the training time should be in the time period close to the actual performance of that activity and based on the daily routine of that activity in a way that does not cause the child's anxiety and panic. o If according to the child's routine, the desired activity or assignment is such that it may not occur at least once during the day, create a simulator or artificial situation and practice at least once a day.o If the child does not pay attention to a part of the video or is distracted, the primary caregiver can use the repeat option to show the stage or stages of the target activity again until the child watches the videos with proper attention. Otherwise, do not use the repeat option.o It is preferable to avoid using the application when the child's attention and concentration are not suitable.o Do not use the application after taking sleeping pills. o After fully viewing all the videos related to the steps of a particular activity, the child will look at the steps step by step and after completing each step, the mother will choose the correct qualitative option and then after receiving appropriate visual feedback depending on the quality of doing it Step enters the next step.o All the steps related to a particular activity should be done in one go without a break of more than 5 seconds between the steps of the activity.o In case of three consecutive records of independently performing all steps of an activity, the caregiver can no longer use the application to perform that activity.o Avoid showing videos and applications on TV, tablets or other platforms with larger frames. Then the researcher will make the activities determined in the COPM accessible in the carer application. Caregivers will practice at home based on the training provided by the researcher and follow the guidelines and record the quality of the steps in the application. After entering the section dedicated to him in the application, the therapist will monitor the quality of the selected task that the parents mark with three options: "independent", "with help", and "dependent". The communication between the caregiver and the researcher will be done through the messaging section of the application or by calling. In case of three consecutive records of independently performing all steps of an activity, the caregiver can no longer use the application to perform that activity. The intervention process will be implemented for one to months on the intervention group. The researcher will send 3 reminder messages to the caregivers via WhatsApp. From the management panel website, the caregivers' adherence and fidelity to interventions will be implemetend.
    گروه مداخله: در گروه مداخله، اولین قدم نصب اپلیکیشن بر روی گوشی تلفن همراه هوشمند مراقب مسئول اجرای مداخله و آموزش نحوه استفاده از آن خواهد بود. در این آموزش از مراقب خواسته می‌شود که برای تمرین، حداقل دو فعالیت که اجرای آن‌ها در مرکز امکان‌پذیر است را تحت نظر محقق اجرا کند تا اشکالات احتمالی رفع و نکات لازم به ایشان بازخورد داده شود. به منظور اطمینان حاصل کردن از صحت و یکپارچه بودن روند انجام آموزش توسط والدین، علاوه بر قسمت دستورالعمل در داخل اپلیکیشن، برگه‌ی راهنمایی نیز به والدین ارائه خواهد شد که موارد آن به شرح ذیل خواهد بود: o در هنگام تماشای فیلم‌ها، بهتر است با کودک صحبت نشود (از دادن راهنمایی کلامی اجتناب گردد) تا بتواند همه‌ی توجه‌اش را بر روی آموزش فیلم حفظ کند. مراقب اصلی صرفا می‌تواند از راهنمایی فیزیکی حداقلی در حد کمک به فهم بیشتر کودک از اجرای درست الگوی حرکتی صحیح انجام فعالیت مورد نظر استفاده کند.o مراقب اصلی می‌تواند از سرنخ یا نماد آشنا و معنادار برای کودک خود به عنوان تداعی‌گر فعالیت هدف مدنظر (مانند "به به" یا "هام هام" برای تداعی فعالیت غذا خوردن) برای آماده کردن کودک استفاده کند.o تا حد ممکن، زمان آموزش در بازه‌ی زمانی نزدیک به انجام واقعی آن فعالیت و بر اساس روتین انجام روزمره‌ی آن فعالیت باشد به گونه‌ای که باعث اضطرار و قشقرق کودک نشود.o اگر با توجه به روتین کودک، فعالیت یا تکلیف مورد نظر، به گونه‌ای است که ممکن است در طول روز حداقل به تعداد یک‌بار هم پیش نیاید، موقعیت شبیه‌ساز یا تصنعی ایجاد شود و حداقل یک‌بار در روز تمرین انجام گیرد.o اگر کودک به بخشی از ویدیو توجه نکرد یا حواسش پرت شد، مراقب اصلی می‌تواند تا زمانی که کودک با توجه مناسب به ویدیوها نگاه کند، از گزینه‌ی تکرار برای نمایش مجدد مرحله یا مراحلی از فعالیت هدف استفاده نماید. در غیر این‌صورت از گزینه‌ی تکرار استفاده نشود.o ترجیحا زمانی که توجه و تمرکز کودک مناسب نیست، از استفاده از اپلیکیشن اجتناب گردد.o بعد از خوردن داروهای خواب‌آور از اپلیکیشن استفاده نگردد.o بعد از مشاهده‌ی کامل تمامی ویدیوهای مربوط به مراحل یک فعالیت بخصوص، کودک مرحله به مرحله گام‌ها را نگاه خواهد کرد و بعد از اتمام هر مرحله، مادر گزینه‌ی کیفی صحیح را انتخاب می‌نماید و سپس بعد از دریافت فیدبک بصری مناسب بسته به کیفیت انجام آن مرحله، وارد مرحله‌ی بعدی می‌گردد. o همه‌ی مراحل مربوط به یک فعالیت بخصوص، به‌صورت یکپارچه بدون وقفه‌ی بیش از 5 ثانیه بین مراحل فعالیت انجام گردد.o در صورت سه ثبت متوالی انجام مستقل همه‌ی مراحل یک فعالیت، مراقب می‌تواند دیگر برای آنجام آن فعالیت از اپلیکیشن استفاده نکند. o از نمایش ویدیوها و اپلیکیشن در بستر تلویزیون، تبلت و یا سایر بسترهایی با قاب بزرگ‌تر اجتناب گردد.سپس محقق فعالیت‌های تعیین‌شده در COPM ‌را در اپلیکیشن مراقب قابل دستیابی خواهد کرد. مراقب براساس آموزشی که محقق به آن‌ها داده و با رعایت نکات راهنما، به تمرین در منزل خواهند پرداخت و کیفیت انجام مراحل را در اپلیکیشن ثبت خواهند کرد. درمانگر پس از ورود به بخش اختصاص یافته به خود در داخل اپلیکیشن، میزان کیفیت انجام تکلیف انتخاب شده را که والدین با سه گزینه‌ی "مستقل"، "با کمک"، و "وابسته" علامت می‌زنند مانیتور خواهد کرد. ارتباط مراقب با محقق هم از طریق بخش پیام‌رسان اپلیکیشن و در قالب ارسال ویدیو یا پیام صوتی و متنی انجام خواهد گرفت. در طول دوره‌ی مداخله، هر مراقب می‌تواند حداکثر سه بار پرسش داشته باشد تا فرکانس پاسخ‌دهی در تمامی نمونه‌های گروه مداخله به یک میزان باشد. ‌هر دو هفته یک‌بار از طریق تماس ویدیویی یا ارسال ویدیو در بستر اپلیکیشن از آموزش و تمرین مراقب با کودک در منزل، نظارت بر عملکرد والدین یا online under supervision learning، انجام خواهد گرفت تا خطاهای احتمالی در رود اجرا و آموزش والدین بازخورد داده شود. در صورت سه ثبت متوالی انجام مستقل همه‌ی مراحل یک فعالیت، مراقب می‌تواند دیگر برای آنجام آن فعالیت از اپلیکیشن استفاده نکند. روند مداخله نهایت به مدت دو ماه بر روی گروه مداخله اجرا خواهد شد.
    گروه مداخله: در گروه مداخله، اولین قدم نصب اپلیکیشن بر روی گوشی تلفن همراه هوشمند مراقب مسئول اجرای مداخله و آموزش نحوه استفاده از آن خواهد بود. در این آموزش از مراقب خواسته می‌شود که برای تمرین، حداقل دو فعالیت که اجرای آن‌ها در مرکز امکان‌پذیر است را تحت نظر محقق اجرا کند تا اشکالات احتمالی رفع و نکات لازم به ایشان بازخورد داده شود. به منظور اطمینان حاصل کردن از صحت و یکپارچه بودن روند انجام آموزش توسط والدین، علاوه بر قسمت دستورالعمل در داخل اپلیکیشن، برگه‌ی راهنمایی نیز به والدین ارائه خواهد شد که موارد آن به شرح ذیل خواهد بود: o در هنگام تماشای فیلم‌ها، بهتر است با کودک صحبت نشود (از دادن راهنمایی کلامی اجتناب گردد) تا بتواند همه‌ی توجه‌اش را بر روی آموزش فیلم حفظ کند. مراقب اصلی صرفا می‌تواند از راهنمایی فیزیکی حداقلی در حد کمک به فهم بیشتر کودک از اجرای درست الگوی حرکتی صحیح انجام فعالیت مورد نظر استفاده کند.o مراقب اصلی می‌تواند از سرنخ یا نماد آشنا و معنادار برای کودک خود به عنوان تداعی‌گر فعالیت هدف مدنظر (مانند "به به" یا "هام هام" برای تداعی فعالیت غذا خوردن) برای آماده کردن کودک استفاده کند.o تا حد ممکن، زمان آموزش در بازه‌ی زمانی نزدیک به انجام واقعی آن فعالیت و بر اساس روتین انجام روزمره‌ی آن فعالیت باشد به گونه‌ای که باعث اضطرار و قشقرق کودک نشود.o اگر با توجه به روتین کودک، فعالیت یا تکلیف مورد نظر، به گونه‌ای است که ممکن است در طول روز حداقل به تعداد یک‌بار هم پیش نیاید، موقعیت شبیه‌ساز یا تصنعی ایجاد شود و حداقل یک‌بار در روز تمرین انجام گیرد.o اگر کودک به بخشی از ویدیو توجه نکرد یا حواسش پرت شد، مراقب اصلی می‌تواند تا زمانی که کودک با توجه مناسب به ویدیوها نگاه کند، از گزینه‌ی تکرار برای نمایش مجدد مرحله یا مراحلی از فعالیت هدف استفاده نماید. در غیر این‌صورت از گزینه‌ی تکرار استفاده نشود.o ترجیحا زمانی که توجه و تمرکز کودک مناسب نیست، از استفاده از اپلیکیشن اجتناب گردد.o بعد از خوردن داروهای خواب‌آور از اپلیکیشن استفاده نگردد.o بعد از مشاهده‌ی کامل تمامی ویدیوهای مربوط به مراحل یک فعالیت بخصوص، کودک مرحله به مرحله گام‌ها را نگاه خواهد کرد و بعد از اتمام هر مرحله، مادر گزینه‌ی کیفی صحیح را انتخاب می‌نماید و سپس بعد از دریافت فیدبک بصری مناسب بسته به کیفیت انجام آن مرحله، وارد مرحله‌ی بعدی می‌گردد. o همه‌ی مراحل مربوط به یک فعالیت بخصوص، به‌صورت یکپارچه بدون وقفه‌ی بیش از 5 ثانیه بین مراحل فعالیت انجام گردد.o در صورت سه ثبت متوالی انجام مستقل همه‌ی مراحل یک فعالیت، مراقب می‌تواند دیگر برای آنجام آن فعالیت از اپلیکیشن استفاده نکند. o از نمایش ویدیوها و اپلیکیشن در بستر تلویزیون، تبلت و یا سایر بسترهایی با قاب بزرگ‌تر اجتناب گردد.سپس محقق فعالیت‌های تعیین‌شده در COPM ‌را در اپلیکیشن مراقب قابل دستیابی خواهد کرد. مراقب براساس آموزشی که محقق به آن‌ها داده و با رعایت نکات راهنما، به تمرین در منزل خواهند پرداخت و کیفیت انجام مراحل را در اپلیکیشن ثبت خواهند کرد. درمانگر پس از ورود به بخش اختصاص یافته به خود در داخل اپلیکیشن، میزان کیفیت انجام تکلیف انتخاب شده را که والدین با سه گزینه‌ی "مستقل"، "با کمک"، و "وابسته" علامت می‌زنند مانیتور خواهد کرد. ارتباط مراقب با محقق هم از طریق بخش پیام‌رسان اپلیکیشن و در قالب ارسال ویدیو یا پیام صوتی و متنی انجام خواهد گرفت. در صورت سه ثبت متوالی انجام مستقل همه‌ی مراحل یک فعالیت، مراقب می‌تواند دیگر برای آنجام آن فعالیت از اپلیکیشن استفاده نکند. روند مداخله نهایت به مدت یک ماه بر روی گروه مداخله اجرا خواهد شد.
    #2
    Control group: In this study, the control group will receive routine occupational therapy services for children with ASD conducted by an occupational therapist, which typically includes sensory, behavioral, and developmental integration approaches (47). Therapists of these samples will be asked not to use VM during the study; Because after the follow-up phase, the application will also be presented to the control group. Also, in order to ensure the intervention program of the occupational therapists for all children in the control group, a letter will be delivered to the therapists and the following will be written in it:o During the two months of the present plan, self-care activities should not be taught with live modeling. The entire training related to self-care activities should not be an imitation of a demonstration by youo Visual or verbal videos regarding teaching self-care activities should not be shown or recommended to the child or family.And once every two weeks, through a video call with the therapist during the treatment session, or by sending a video or receiving a report of the child's treatment plan in the treatment sessions, the correctness of the treatment implementation process of the control group will be ensured.
    Control group: In this study, the control group will receive live modeling by the main caregiver at home. Therapists of these samples will be asked not to use VM during the study; because after the follow-up phase, the application will also be presented to the control group. Three reminder messages a week in WhatsApp will be delivered to families. Based on logbook, the caregivers adherence to treatment will be monitored.
    گروه کنترل: در این مطالعه گروه کنترل درمان روتین خدمات کاردرمانی برای کودکان با ASD را که توسط کاردرمانگر در حال انجام است دریافت خواهند کرد که به طور معمول شامل رویکردهای یکپارچگی حسی، رفتاری، و تکاملی است (47). از درمانگرانِ این نمونه‌ها خواسته خواهد شد تا در طی مطالعه از VM استفاده نکنند؛ چرا که بعد از فاز پیگیری، اپلیکیشن به گروه کنترل نیز ارائه خواهد شد. هم‌چنین، به منظور اطمینان حاصل کردن از برنامه‌ی مداخلاتی کاردرمانگران تمامی کودکان گروه کنترل، نامه‌ای به درمانگران تحویل داده خواهد شد و در آن موارد ذیل نگارش خواهد شد: o در طی دو ماه طرح حاضر، آموزش فعالیت‌های خودمراقبتی با الگودهی زنده انجام نگرددo کل آموزش‌های مرتبط با فعالیت‌های خودمراقبتی به شکل تقلید از demonstration توسط شما نباشدo ویدیوهای تصویری یا کلامی در رابطه با آموزش فعالیت‌های خودمراقبتی به کودک یا خانواده نمایش یا توصیه داده نشود.و هر دو هفته یک‌بار از طریق تماس ویدیویی با درمانگر در طول جلسه‌ی درمانی یا ارسال ویدیو و یا دریافت گزارش از برنامه‌ی درمانی کودک در جلسات درمانی، از صحت روند اجرای درمان گروه کنترل اطمینان کسب خواهد شد.
    گروه کنترل: در این مطالعه در گروه کنترل، مراقب اصلی از الگودهی زنده در منزل کودک برای نمایش فعالیتهای خودمراقبتی استفاده میکند. از درمانگرانِ این نمونه‌ها خواسته خواهد شد تا در طی مطالعه از VM استفاده نکنند؛ چرا که بعد از فاز پیگیری، اپلیکیشن به گروه کنترل نیز ارائه خواهد شد. هم‌چنین، به منظور اطمینان حاصل کردن از برنامه‌ی مداخلاتی کاردرمانگران تمامی کودکان گروه کنترل، نامه‌ای به درمانگران تحویل داده خواهد شد و در آن موارد ذیل نگارش خواهد شد: o در طی دو ماه طرح حاضر، آموزش فعالیت‌های خودمراقبتی با الگودهی زنده انجام نگرددo کل آموزش‌های مرتبط با فعالیت‌های خودمراقبتی به شکل تقلید از demonstration توسط شما نباشدo ویدیوهای تصویری یا کلامی در رابطه با آموزش فعالیت‌های خودمراقبتی به کودک یا خانواده نمایش یا توصیه داده نشود.و هر دو هفته یک‌بار از طریق تماس ویدیویی با درمانگر در طول جلسه‌ی درمانی یا ارسال ویدیو و یا دریافت گزارش از برنامه‌ی درمانی کودک در جلسات درمانی، از صحت روند اجرای درمان گروه کنترل اطمینان کسب خواهد شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Arman Shayan
    Name of recruitment center - Persian: آرمان شایان
    Full name of responsible person - English: Dr. Mehdi Alizadeh
    Full name of responsible person - Persian: مهدی علیزاده زارعی
    Street address - English: Sadeghiyyeh, Behnam st., Arman Shayan
    Street address - Persian: فلکه دوم صادقیه، خیابان آیت اله کاشانی، خیابان بهنام، روبروی بوستان تربیت، موسسه خیریه توانبخشی پزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۹۶۸۶۳۳۸۹۳
    Phone: +98 912 307 0065
    Fax:
    Email: mehdii.alizadeh@yahoo.com
    Web page address:
    Name of recruitment center - English: Parsian
    Name of recruitment center - Persian: پارسیان
    Full name of responsible person - English: Dr. Mehdi Alizadeh
    Full name of responsible person - Persian: مهدی علیزاده زارعی
    Street address - English: Sadeghiyyeh, Behnam st., Arman Shayan
    Street address - Persian: فلکه دوم صادقیه، خیابان آیت اله کاشانی، خیابان بهنام، روبروی بوستان تربیت، موسسه خیریه توانبخشی پزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1968633893
    Phone: +98 912 307 0065
    Fax:
    Email: mehdii.alizadeh@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Aliasgar hospital
    Name of recruitment center - Persian: بیمارستان علی اصغر
    Full name of responsible person - English: Dr. Samaneh Karamali Smaeli
    Full name of responsible person - Persian: سمانه کرمعلی اسماعیلی
    Street address - English: Zafar st. Aliasgar hospital
    Street address - Persian: بزرگراه آيت الله مدرس، خيابان شهيد وحيد دستگردي (ظفر سابق)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1919816766
    Phone: +98 21 2222 2043
    Fax:
    Email: samauneh.esmaeili@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr. Hossein Keivani
    Full name of responsible person - Persian: دکتر حسین کیوانی
    Street address - English: Hemmat highway, Iran University of Medical Sciences
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 86701
    Fax:
    Email: Keyvanlab@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr. Hossein Keivani
    Full name of responsible person - Persian: دکتر حسین کیوانی
    Street address - English: Hemmat highway, Iran University of Medical Sciences
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 86701
    Fax:
    Email: Keyvanlab@yahoo.com
    Web page address:
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Samane Zohrabi
    Full name of responsible person - Persian: سمانه زهرابی
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Mirdamad, Shahnazari, Rehabilitation faculty of IUMS
    Street address - Persian: میرداماد، خیابان شاه نظری، مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Mobile: +98 914 932 9907
    Fax:
    Email: samane_zohrabi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Samane Zohrabi
    Full name of responsible person - Persian: سمانه زهرابی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
    Street address - Persian: میرداماد، خیابان شاه نظری، مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Mobile: +98 914 932 9907
    Fax:
    Email: samane_zohrabi@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Samane Zohrabi
    Full name of responsible person - Persian: سمانه زهرابی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Mirdamad, madadkaran, Rehabilitation faculty of IUMS
    Street address - Persian: میرداماد، مددکاران، دانشکده علوم توانبخشی دانشگاه ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 2059
    Mobile: +98 914 932 9907
    Fax:
    Email: samane_zohrabi@yahoo.vom
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Samane Zohrabi
    Full name of responsible person - Persian: سمانه زهرابی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
    Street address - Persian: میرداماد، مددکاران، دانشکده علوم توانبخشی دانشگاه ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 2059
    Mobile: +98 914 932 9907
    Fax:
    Email: samane_zohrabi@yahoo.vom
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Samane Zohrabi
    Full name of responsible person - Persian: سمانه زهرابی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Mirdamad, Shahnazari st., Madadkaran st., Rehabilitation faculty of IUMS
    Street address - Persian: میرداماد، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 41 3382 2915
    Mobile: +98 914 932 9907
    Fax:
    Email: samane_zohrabi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Samane Zohrabi
    Full name of responsible person - Persian: سمانه زهرابی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 72
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
    Street address - Persian: میرداماد، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 41 3382 2915
    Mobile: +98 914 932 9907
    Fax:
    Email: samane_zohrabi@yahoo.com
    Web page address:

Protocol summary

Study aim
Investigating the effectiveness of the therapist-managed smartphone application for teaching self-care activities in improving the self-care performance of children with autism spectrum disorder, their parents' participation in rehabilitation, and parent's psychosocial state
Design
Single-blind (examiner) two-arm parallel randomized controlled trial (RCT), with a four-block randomization method. The sample size was considered as 30 children with ASD and their primary caregiver.
Settings and conduct
This study will be a randomized and one-sided blind (examiner) clinical trial. The study population will include children with ASD referred to rehabilitation centers, autism centers or exceptional schools for autism in Tehran city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having an ASD diagnosis by a child psychiatrist; The severity of autism according to the GARS test is level 1 or 2; Being a child in the age range of 5 to 12 years; According to COPM, difficulty in performing at least three self-care activities is among the main complaints of the family about the child; Being a child under occupational therapy so that self-care goals are pursued by the occupational therapist through common interventions; Ability to pay attention to images or videos on the screen for at least five minutes based on parent report; Obtaining a score above 16 in MIS in order to have the minimum ability to imitate in the use of VM; not having behavioral issues in the child based on the CSI-4
Intervention groups
In this study, the control group will receive live modeling by the main caregiver at home.The intervention group will receive the self-care activity training application to be used and practiced at home under the supervision of the therapist and researcher.
Main outcome variables
Application; self-care performance; family functioning in rehabilitation, parent's psychosocial status

General information

Reason for update
After implementing a pilot study of the using application, some changes seemed to be required to have a more concise results.
Acronym
IRCT registration information
IRCT registration number: IRCT20231124060165N1
Registration date: 2023-12-09, 1402/09/18
Registration timing: prospective

Last update: 2025-04-15, 1404/01/26
Update count: 1
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Samane Zohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 2915
Email address
samane_zohrabi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
2024-04-20, 1403/02/01
Actual recruitment end date
2024-08-20, 1403/05/30
Trial completion date
2025-11-21, 1404/08/30
Scientific title
Investigating effectiveness of the therapist-managed self-care training smartphone application based on video-modeling for children with autism spectrum disorder and their parents
Public title
Investigating effectiveness of the smartphone application of training self-care activities on self-care performance of children with autism spectrum disorderو their parents’ participation in rehabilitation and psychological state
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having an ASD diagnosis by a child psychiatrist The severity of autism according to the GARS-3 test is level 1 or 2 Being a child in the age range of 5 to 12 years According to COPM, difficulty in performing at least three self-care activities is among the main complaints of the family about the child Participating in occupational therapy sessions so that self-care goals are pursued by the occupational therapist through common interventions. Ability to pay attention to images or videos on the screen for at least five minutes based on parent report Obtaining a score above 16 in MIS in order to have the minimum imitation ability necessary to use VM Not having behavioral issues in the child based on the child symptom inventory version 4 (CSI-4) with the subscales of attention deficit hyperactivity disorder, oppositional defiant disorder, and conduct disorder (ADHD, ODD, CD) The ability to read and write in parents of children Having an android-based smartphone
Exclusion criteria:
Existence of seizures and severe medical problems in the child based on the medical record or as reported by the parents Implementation of self-care intervention through VM in the child's current treatment plan Having a physical problem in the main caregiver
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Actual sample size reached: 31
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by randomization in blocks of four. Samples will be taken from the four possible blocks and until the samples are completed, they will be allocated between two control and intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be a randomized and one-sided blind (examiner) clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features
An application with the aim of managing the training of self-care activities in children with neurodevelopmental disorders in the form of VM intervention in the android platform of the mobile phone was designed by the present researchers in the form of a technological plan that is going through the stages of construction and pilot study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Mirdamad, Madadkaran st., Rehabilitation University of Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.IUMS.REC.1402.734

Health conditions studied

1

Description of health condition studied
Autism spectrum disorder
ICD-10 code
F84. 0
ICD-10 code description
A type of neurodevelopmental disorder with problems in social interactions and limited and repetitive behaviors and interests

Primary outcomes

1

Description
self-care performance
Timepoint
before intervention, immediately after the intervention, and one month after the end of intervention
Method of measurement
Activities of Daily Living Inventory for Children with Disabilities (ADLIC-D); Canadian Occupational Performance Measure (COPM); Goal Attainment Scale (GAS)

Secondary outcomes

1

Description
Family functioning in rehabilitation
Timepoint
Before the intervention, immediately after the intervention, one month after the end of intervention
Method of measurement
(FFQR) Family Functioning Questionnaire in Rehabilitation

2

Description
Depression, anxiety, and stress of parents of children
Timepoint
Before the intervention, immediately after the intervention, one month after the end of intervention
Method of measurement
Depression, anxiety, stress sacle-42 items (DASS-42)

Intervention groups

1

Description
Intervention group: In the intervention group, the first step is to install the app on the caregiver's smart phone and teach how to use it. In this training, the caregiver is asked to perform at least two activities that can be performed in the center under the supervision of the researcher, so that possible problems can be fixed and the necessary points are given feedback. In order to ensure the correctness and integrity of the training process by parents, in addition to the instruction section inside the application, a video record of app instruction will also be provided to parents. Also, in the app itself there is a guide section consistin the following sentences: The main caregiver can only use minimal physical guidance to the extent of helping the child to understand more about the correct implementation of the correct movement pattern of the desired activity.o The primary caregiver can use a cue or symbol that is familiar and meaningful to their child as an associator of the intended target activity (such as "beh beh" or "hum hum" to evoke the activity of eating) to prepare the child.o As much as possible, the training time should be in the time period close to the actual performance of that activity and based on the daily routine of that activity in a way that does not cause the child's anxiety and panic. o If according to the child's routine, the desired activity or assignment is such that it may not occur at least once during the day, create a simulator or artificial situation and practice at least once a day.o If the child does not pay attention to a part of the video or is distracted, the primary caregiver can use the repeat option to show the stage or stages of the target activity again until the child watches the videos with proper attention. Otherwise, do not use the repeat option.o It is preferable to avoid using the application when the child's attention and concentration are not suitable.o Do not use the application after taking sleeping pills. o After fully viewing all the videos related to the steps of a particular activity, the child will look at the steps step by step and after completing each step, the mother will choose the correct qualitative option and then after receiving appropriate visual feedback depending on the quality of doing it Step enters the next step.o All the steps related to a particular activity should be done in one go without a break of more than 5 seconds between the steps of the activity.o In case of three consecutive records of independently performing all steps of an activity, the caregiver can no longer use the application to perform that activity.o Avoid showing videos and applications on TV, tablets or other platforms with larger frames. Then the researcher will make the activities determined in the COPM accessible in the carer application. Caregivers will practice at home based on the training provided by the researcher and follow the guidelines and record the quality of the steps in the application. After entering the section dedicated to him in the application, the therapist will monitor the quality of the selected task that the parents mark with three options: "independent", "with help", and "dependent". The communication between the caregiver and the researcher will be done through the messaging section of the application or by calling. In case of three consecutive records of independently performing all steps of an activity, the caregiver can no longer use the application to perform that activity. The intervention process will be implemented for one to months on the intervention group. The researcher will send 3 reminder messages to the caregivers via WhatsApp. From the management panel website, the caregivers' adherence and fidelity to interventions will be implemetend.
Category
Rehabilitation

2

Description
Control group: In this study, the control group will receive live modeling by the main caregiver at home. Therapists of these samples will be asked not to use VM during the study; because after the follow-up phase, the application will also be presented to the control group. Three reminder messages a week in WhatsApp will be delivered to families. Based on logbook, the caregivers adherence to treatment will be monitored.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
rehabilitation clinics of Rehabilitation faculty of IUMS
Full name of responsible person
Laleh Lajevardi
Street address
Mirdamad, madadkaran, Rehabilitation faculty of IUMS
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
laleh23275@yahoo.com

2

Recruitment center
Name of recruitment center
Parsian
Full name of responsible person
Dr. Mehdi Alizadeh
Street address
Sadeghiyyeh, Behnam st., Arman Shayan
City
Tehran
Province
Tehran
Postal code
1968633893
Phone
+98 912 307 0065
Email
mehdii.alizadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr. Hossein Keivani
Street address
Hemmat highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Keyvanlab@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samane Zohrabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
samane_zohrabi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samane Zohrabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
samane_zohrabi@yahoo.vom

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samane Zohrabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 41 3382 2915
Fax
Email
samane_zohrabi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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