The effectiveness of language based executive function program on improving cognitive and language abilities and reducing behavioral problems in cochlear implanted children
Examining the effectiveness of language-based executive function training on improving language and cognitive skills and reducing behavior problems
Design
24 participants were randomly assigned to experimental and control groups. The experimental group will receive language-based executive function training. The control group will not receive this training.
Settings and conduct
Before the intervention, children are assessed by Test of Language Development, Binet Working Memory Test, Structured Observation of Self-regulation and Dimensional Change Card Sort. Strength and Difficulties Questionnaire is filled by mothers as well. Then, participants will be assigned to two groups. experimental group will receive Executive function training (inhibition, working memory and cognitive flexibility) in 18 sessions. After finishing the training sessions post-test will be performed.
Participants/Inclusion and exclusion criteria
Target population: preschool cochlear implanted children of Sokhan rehabilitation center in Qom. inclusion criteria: Age range (4-7 years old), At least, one year interval between cochlear implant operation and the study
exclusion criteria: Psychiatric drug usage, signs of any other physical illness and psychological problems, lack of motivation of the child or parents' desire on continuing cognitive training
Intervention groups
Intervention group: cochlear implanted children who receive language-based executive function training
Control group: cochlear implanted children without language-based executive function training
Main outcome variables
language skills, cognitive skills ( inhibition, working memory, cognitive flexibility) and behavior problems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230515058200N1
Registration date:2023-05-28, 1402/03/07
Registration timing:registered_while_recruiting
Last update:2023-05-28, 1402/03/07
Update count:0
Registration date
2023-05-28, 1402/03/07
Registrant information
Name
Samaneh Haji khodadadi
Name of organization / entity
Lorestan University
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 2979
Email address
hajikhodadadi.sm@fh.lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-07-20, 1402/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of language based executive function program on improving cognitive and language abilities and reducing behavioral problems in cochlear implanted children
Public title
The effectiveness of executive function training on cochlear implanted children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 4-7
At least, one year interval between cochlear implant operation and the study
Normal range intelligence quotient
Exclusion criteria:
Psychiatric drug usage
signs of any other physical illness and psychological problems
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomizing, single, with the table of random numbers: First, a number, from 1 to 24, is assigned to each participant. Then we start from a random number in the table as the start point and move in that line to the right. Numbers less or equal 24 are chosen. The first 12 numbers would be in the intervention group and the remaining numbers would be in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences., Anooshirvan Rezaei Square., Moalem St., Khorramabad,
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.LUMS.REC.1402.047
Health conditions studied
1
Description of health condition studied
Hearing loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral
Primary outcomes
1
Description
Subscale scores of Test of Language Development
Timepoint
Before the intervention - after the intervention
Method of measurement
Test of Language Development
2
Description
cognitive skills that will be assessed by inhibition, working memory and cognitive flexibility tests.
Subscale scores of Strength and Difficulties Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Language-based executive function training. This study is performed in Sokhan rehabilitation center in 18 sessions in 1 month and a half. First, exercises will be designed according to learning content. Then, essential tools such as toys and pictures will be prepared. the exercises will be set in a way that require the child's verbal response for instance: digit or word span in working memory training or day/night stroop in inhibition training.
Category
Rehabilitation
2
Description
Control group: This group does not receive the training program developed in this study.