The investigation of efficacy of theory of mind practices on perception of mental verbs in Farsi-speaking children aged 5-7 -year- old with hearing aid and cochlear implant
Effectiveness of theory of mind exercises on perception of mental verbs in Persian children with hearing aid and cochlear implant
Design
We choose the children based on inclusion and exclusion criteria. After that we will doing Randomized, parallel group trial with blinded outcome assessment. Randomization will performed with sealed envelopes in each of the intervention and control groups.
Settings and conduct
The children will be grouped in a simple random manner. Children in groups A and B are cochlear implant users and in groups C and D are hearing aid users, A and C were as intervention groups and groups B and D were as as control groups. First, the perception of mental verbs and the theory of mind of children in each group are examined and the scores are recorded. Theory of mind exercises are performed twice a week for both intervention groups for 8 weeks by speech therapist. Finally, the children's understanding of mental verbs is re-evaluated, and then the scores of each group before and after the study are compared with the control group. Mental verbs and theory of mind skills will be re-assessment after one month.
Participants/Inclusion and exclusion criteria
Normal IQ, sensorineural type congenital hearing loss, Unilateral cochlear implant, At least one year has passed since receiving the prosthesis ,Farsi language, Ability to speak simple sentences; Absence of cognitive, sensory, neurological, psychological and emotional problems
Intervention groups
Children with hearing impairment who use hearing aids and cochlear implant will be randomly assigned to four intervention and control groups
Main outcome variables
improvement in theory of mind and perception of mental verb
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230827059274N1
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Fatemeh Hassanati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7173 2847
Email address
fa.hasanati@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of efficacy of theory of mind practices on perception of mental verbs in Farsi-speaking children aged 5-7 -year- old with hearing aid and cochlear implant
Public title
The efficacy of theory of mind practices on perception of mental verbs
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
IQ in the normal range
congenital hearing loss before the language learning period of sensorineural type
Unilateral cochlear implantation before 5 years of age
At least one year has passed since receiving the prosthesis
Passing speech therapy programs in the past year
Predominance of Farsi language in the speech of the child and her family(feminine)
Ability to speak simple sentences
Age range between 5 and 7 years
Natural cognitive skills based on children's history and medical records and the Wechsler intelligence test, which is administered by a psychologist
Absence of sensory problems such as blindness diagnosed by a specialist doctor based on the history and medical records of children
Absence of neurological problems such as movement disorders and paralysis in the limbs and face, epilepsy and convulsions diagnosed by a specialist doctor based on the history and medical file of children
Absence of psychological and emotional problems such as mental retardation, hyperactivity, autism, and medical syndromes
No receiving interventions in the field of theory of mind or understanding mental actions
Exclusion criteria:
Discontinuing the research process on behalf of the child or the child's parents
Prosthesis or hearing aid failure or the need for major repairs that lead to the child being deprived of the prosthesis for several weeks
The occurrence of diseases that lead to the process of research interventions being interrupted for several weeks (simple colds are excluded from this rule)
History of receiving theory of mind exercises
Using hearing aids and cochlear implants at the same time
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
First, based on the inclusion and inclusion criteria, the names of eligible children are extracted and their names are placed in a simple random manner and individually in sealed envelopes in each of the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluators who rate, code and analyze the results will be unaware of the demographic information of the children, the time period of the evaluations and the grouping of the children. Therefore, the present randomized clinical trial is a blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation sciences
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., Daneshjo Blvd.,Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-08-22, 1402/05/31
Ethics committee reference number
IR.USWR.REC.1402.094
Health conditions studied
1
Description of health condition studied
hearing loss
ICD-10 code
H91.90
ICD-10 code description
Unspecified hearing loss, unspecified ear
Primary outcomes
1
Description
Improvement in perception of mental verbs with changing in perception of mental verb test.
Timepoint
8 weeks
Method of measurement
Perception of mental verbs test
2
Description
Improvement in theory of mind
Timepoint
8 weeks
Method of measurement
Perception of theory of mind test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children with hearing impairment who use hearing aids and cochlear implant (2 intervention groups) will be evaluated by mental verb perception test and theory of mind test. Then, the theory of mind intervention will be implemented for 16 sessions of thirty minutes in 8 weeks. One month after the end of the intervention period, evaluations will be done again and the amount of changes will be recorded.
Category
Rehabilitation
2
Description
Control group: Children with hearing impairment who use hearing aids and cochlear implant (2 intervention groups) will be evaluated by mental verb perception and theory of mind test. Then, for 16 sessions of thirty minutes in 8 weeks, common speech therapy will be performed. One month after the end of the intervention period, evaluations will be done again and the amount of changes will be recorded.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sokhan center
Full name of responsible person
Zahra Haj Gholamrezaee
Street address
13 alley, Jahad street, Kerman
City
Kerman
Province
Kerman
Postal code
03432730324
Phone
+98 76 1983 7761
Email
h.rezaee.zahra@gmail.com
2
Recruitment center
Name of recruitment center
Gooyesh center
Full name of responsible person
Mina Raji
Street address
2 Alley, Madani Street, Atashneshani Blvd, Bam
City
Bam
Province
Kerman
Postal code
7661415364
Phone
+98 913 840 3017
Email
minatums89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khanke
Street address
University of Social Welfare and Rehabilitation- Kudakyar Alley- Daneshju Blvd.- Evin- Tehran- Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Hassanati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
University of Social Welfare and Rehabilitation, Kudakyar Alley, Daneshju Blvd., Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2847
Email
fatemeh_hasanati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
ّFatemh hassanati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., daneshjo Blvd.,Evin, Tehran
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2847
Email
fatemeh_hasanati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
fatemeh hassanati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., daneshjo Blvd.,Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2847
Email
fatemeh_hasanati@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information remains confidential with the researcher
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The information will be sent to the welfare and exceptional education organization in the form of a protocol, which will be used if approved
When the data will become available and for how long
2025
To whom data/document is available
The final protocol will be available to researchers and therapists
Under which criteria data/document could be used
It can be used in research and clinical matters by regarding the principles of trustworthiness and following the correct principles of its methods
From where data/document is obtainable
Main researcher or published article
What processes are involved for a request to access data/document
Sending email and signing the contract to comply with the ethical principles of using the protocol