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 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
Design
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.
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
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
Intervention groups
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.
Main outcome variables
application; self-care performance; participation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231124060165N1
Registration date:2023-12-09, 1402/09/18
Registration timing:prospective
Last update:2023-12-09, 1402/09/18
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
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Education/Guidance
Inclusion/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
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
Exclusion criteria:
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
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:
50
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
Single
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
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).
Timepoint
before the start of the intervention, 2 months, and three months after the start of the intervention
Method of measurement
Activities of Daily Living Inventory for Children with Disabilities; (COPM) Canadian Occupational Performance Measure; (GAS) Goal Attainment Scale
Secondary outcomes
1
Description
participation
Timepoint
Before the intervention, two and three months after the intervention
Method of measurement
(FFQR) Family Functioning Questionnaire in Rehabilitation
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 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.
Category
Rehabilitation
2
Description
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.
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
Arman Shayan
Full name of responsible person
Dr. Mehdi Alizadeh
Street address
Sadeghiyyeh, Behnam st., Arman Shayan
City
Tehran
Province
Tehran
Postal code
۱۹۶۸۶۳۳۸۹۳
Phone
+98 912 307 0065
Email
mehdii.alizadeh@yahoo.com
3
Recruitment center
Name of recruitment center
Aliasgar hospital
Full name of responsible person
Dr. Samaneh Karamali Smaeli
Street address
Zafar st. Aliasgar hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2043
Email
samauneh.esmaeili@gmail.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
۱۴۴۹۶۱۴۵۳۵
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
Mirdamad, Shahnazari, Rehabilitation faculty of IUMS
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
Mirdamad, madadkaran, Rehabilitation faculty of IUMS
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
Mirdamad, Shahnazari st., Madadkaran st., Rehabilitation faculty of IUMS
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