Protocol summary
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Study aim
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Developing an educational video for parents and investigating its effectiveness on communication and play skills of non-verbal ASD children
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Design
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Clinical trial with control group, single blind, randomized, on 32 patients. For randomization, random selection of 32 envelopes containing one of the control and intervention words was used (16 envelopes containing the control word and 16 envelopes containing the intervention word).
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Settings and conduct
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Parents and non-verbal autistic children aged 3 to 6 living in remote cities without proper rehabilitation facilities participate in this research. Subjects are randomly divided into intervention and control groups, and none of the parents know which study group they are in.
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Participants/Inclusion and exclusion criteria
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Children's Inclusion criteria:
Having ASD and not having verbal communication
Not using face-to-face speech therapy services
Having normal vision, hearing and movement
Parents Inclusion criteria:
Having high speed internet access.
Not having psychiatric disorders such as major depression
Children's exclusion criteria:
Using face-to-face speech therapy services after entering the study.
Parents exclusion criteria:
Unwillingness to continue receiving the treatment program through telepractice.
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Intervention groups
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The intervention group receives DVDs containing educational videos and implements educational techniques for their ASD child by following the videos.
The control group does not use any type of speech therapy intervention and waits to receive the educational DVD.
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Main outcome variables
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Empowering parents to provide early evidence-based interventions to ASD children; facilitating the benefit of ASD children living in remote areas from evidence-based speech therapy interventions.
General information
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Reason for update
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With respect, we remind you that at the time of registration of our trial in the Iranian Clinical Trials System (IRCT), our initial sample size, according to the study proposal, included 18 subjects. These people were supposed to be divided equally between two intervention and control groups, with 9 subjects in each group.
However, during the implementation of the intervention and data collection, due to the overwhelming response from families, we realized that we could expand our support to this disadvantaged population living in rural areas. Due to the lack of access of these families to face-to-face speech therapy interventions, we decided to include more eligible families in the study. As a result, the final sample size for our study increased to 32 subjects. To maintain statistical accuracy, we randomly divided these subjects into two study groups, each including 16 subjects. Therefore, please allow us to update the sample size for this trial.
Also, due to the participation of 3-6 year old children in this research, please allow the age range of the participants to be changed from 2-6 years to 3-6 years.
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Acronym
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ASD
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IRCT registration information
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IRCT registration number:
IRCT20180716040486N1
Registration date:
2023-01-31, 1401/11/11
Registration timing:
registered_while_recruiting
Last update:
2024-03-19, 1402/12/29
Update count:
1
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Registration date
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2023-01-31, 1401/11/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-15, 1401/07/23
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Expected recruitment end date
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2022-12-20, 1401/09/29
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Actual recruitment start date
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2023-01-30, 1401/11/10
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Actual recruitment end date
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2023-03-04, 1401/12/13
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Trial completion date
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2023-09-20, 1402/06/29
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Scientific title
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Developing Instructional Video for Parents and Investigating its Effectiveness on Communication and Play Skills of Nonverbal Children with Autism Spectrum Disorders
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Public title
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educating parents of children with ASD
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Based on the diagnostic criteria of DSMV, the child has ASD.
The child has the intention to communicate but uses unconventional means of communication (for example, directing the parent towards the requested object by pulling his hand or clothes or using his hand as a tool) to communicate.
The child does not use conventional non-verbal communication tools (gesture, eye contact, or non-verbal vocalizations) or speech to communicate.
Given play level, the child is in the stage of exploratory play and is not able to perform functional play.
Children of both intervention groups should not use face-to-face speech therapy services before entering the study.
The child should benefit from normal vision, hearing and movement status.
The parent has no previous experience of receiving Parent-Child Interaction Therapy (PCIT).
The parent has access to one of the smart communication devices (smartphones or tablets).
One of the messaging software with video call capability (preferably WhatsApp) must be installed on the parent's smart communication device.
The parent has access to one of the necessary electronic equipment for DVD playback (personal computer, laptop or DVD player) or suitable electronic tools for displaying video files in flash memory (TV or digital flash receiver).
The parent has access to ADSL internet with a bandwidth of 8 megabytes and above or preferably fourth generation mobile internet (4G).
The parent does not suffer from psychiatric disorders such as major depression.
Exclusion criteria:
Children's use of face-to-face speech therapy services after entering the study
Parents' unwillingness to continue the treatment program through telepractice.
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Age
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From 3 years old to 6 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
18
Actual sample size reached:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Subjects are randomly divided into intervention and control groups. For the random allocation of the subjects, the following steps are taken: a) determining the total sample size (32 subjects) and assigning codes 1 to 32 for each child, b) assigning sheets containing the short name of the target group in proportion to the number of sample size in each group (16 sheets containing the title of control and 16 sheets containing the title of intervention), c) placing the sheets in non-transparent envelopes, d) Picking envelopes randomly by someone outside the research team.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Parents were all blinded in regard to the group (intervention or control) they
had been allocated.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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The intervention group is the parents who receive educational DVDs and implement therapeutic techniques for their children by following the educational videos. The control group are parents who do not use any type of speech therapy intervention and are waiting to receive this educational DVD.
Ethics committees
1
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Ethics committee
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Approval date
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2022-07-16, 1401/04/25
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Ethics committee reference number
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IR.TUMS.FNM.REC.1401.049
Health conditions studied
1
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Description of health condition studied
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Autism Spectrum Disorders (ASDs)
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ICD-10 code
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F84
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ICD-10 code description
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Pervasive developmental disorders
Primary outcomes
1
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Description
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mean communication frequency score in children
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Timepoint
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Measuring the mean score of children's communication frequency before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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Video analysis
2
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Description
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mean score of all types of communication purposes in children
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Timepoint
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Measuring the mean score of children's communication purposes before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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Video analysis
3
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Description
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mean score of using communication tools in children
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Timepoint
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Measuring the mean score of children's use of communication tools before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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Video analysis
4
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Description
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mean score of functional play in children
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Timepoint
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Measuring the mean score of children's functional play before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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Video analysis
5
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Description
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mean receptive vocabulary score in children
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Timepoint
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Measuring the children's mean receptive vocabulary score before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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MacArthur-Bates Communicative Development Inventories -1
6
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Description
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mean expressive vocabulary score in children
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Timepoint
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Measuring the children's mean expressive vocabulary score before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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MacArthur-Bates Communicative Development Inventories -1
7
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Description
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mean parent responsiveness score
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Timepoint
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Measuring the mean parent responsiveness score before the intervention, immediately after the end of the intervention and three months after the end of the intervention
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Method of measurement
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Video analysis
Secondary outcomes
1
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Description
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Parents' quality of life score
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Timepoint
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The time periods for measuring the parents' quality of life score are: at the beginning of the study (before the start of the intervention), immediately after the intervention and 3 months after the end of the intervention.
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Method of measurement
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World Health Organization Quality of Life (WHOQOL-BREF)
Intervention groups
1
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Description
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Intervention group: This group will receive a parent education DVD that contains 10 short educational videos that are dedicated to the following topics: 1) the nature of ASD and the challenge of parents in child treatment, 2) strengthening parents' motivation to participate in treatment, 3) turning the home space into an effective educational environment, 4) increasing the frequency of the child's communication, 5) following the child's desires, 6) strengthening the parents' responsiveness, 7) teaching the child to use non-verbal communication tools, 8) teaching joint attention, 9) Teaching the communication intentions of requesting and protesting to the child and 10) teaching the child functional games. In addition to receiving this educational DVD, the researcher will have a video call with the parents of the intervention group twice a week for 3 months to answer the parents' questions regarding the implementation of educational techniques.
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Category
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Rehabilitation
2
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Description
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Control group:Control group: Parents of the control group do not receive parental training DVDs until three months after the start of the study, and they do not use face-to-face speech therapy services for their autistic child. After the completion of the 12-week period of providing the intervention to the intervention group and conducting the post-intervention evaluations, the parent education DVD will be sent to this group as well, and the researcher will answer the parents' questions on the implementation of educational techniques through weekly video calls.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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communication level
pragmatic skills
play level
receptive vocabulary
expressive vocabulary
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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The applicant is only allowed to use the data for statistical analysis.
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From where data/document is obtainable
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Hossein Rezai: Department of Speech Therapy, Rehabilitation faculty, Tehran University of Medical Sciences, corner of Safi Alishah St, Pich Shemiran, Enghelab St
Mobile: 00989177773594
Email: hosseynrezaai@gmail.com
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What processes are involved for a request to access data/document
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To access the research data, please specify your affiliation and tell us how you are going to use the data? After reviewing your request, the data will be sent to you after three working days.
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Comments
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