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IRCT20231124060165N1 IRCT 2023-12-09 Iran University of Medical Sciences 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 Investigating effectiveness of the therapist-managed self-care training smartphone application based on video-modeling for children with autism spectrum disorder and their parents 2024-04-20 anticipated 30 Complete https://irct.ir/trial/74004 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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 description: This study will be a randomized and one-sided blind (examiner) clinical trial. N/A Autism spectrum disorder. Intervention 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 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. Intervention 2: 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. 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 We will decide later.
public Samane Zohrabi
Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 samane_zohrabi@yahoo.com Iran University of Medical Sciences scientific Samane Zohrabi
Rehabilitation faculty of Iran University of Medical Sciences, Madadkaran, Shahnazari, Mother square, Mirdamad st.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 samane_zohrabi@yahoo.vom Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 5 years 12 years Both 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 F84. 0 A type of neurodevelopmental disorder with problems in social interactions and limited and repetitive behaviors and interests Rehabilitation Rehabilitation 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. 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. 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). 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. 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). Iran University of Medical Sciences Approved 2023-11-21 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat highway Tehran Tehran Iran (Islamic Republic of)