The impact of an auditory training program on improving auditory and language skills in hearing-impaired children under three years old, using maternal language instruction and parental emotional support.
To design an auditory training program that improves auditory and language skills in hearing-impaired children under three years old, focusing on native language development and emotional support for their parents.
Design
The clinical trial will have 28 participants, divided into an intervention group and a control group. The study will be double-blind, and the groups will be matched according to age, gender, degree of hearing loss, and the type of assistive device, including hearing aids and cochlear implants.
Settings and conduct
Before the study starts, an audiologist unaware of the group assignments will assess the auditory and receptive language skills of children in both groups using the Persian versions of the IT-MAIS and Macarthur-Bates questionnaires. The parents will also fill out the Persian version of the SPISE-R questionnaire to rate their self-efficacy. During the intervention period, the control group will get aural rehabilitation from the Mother and Child Centers. The intervention group will get this rehabilitation too, and will additionally participate in a weekly 30-minute auditory training program and an eight-week positive parenting program with eight sessions. To measure the program's effect on children's language skills and parents' self-efficacy, we will give both groups the same three questionnaires three months and six months after the program begins. Finally, the collected data will be analyzed by a statistician who is blinded to the group assignments.
Participants/Inclusion and exclusion criteria
Children between 9 and 24 months old with moderate to profound hearing loss in both ears.
Intervention groups
Children between 9 and 24 months old with hearing impairments who receive aural rehabilitation services at Mother and Child Centers in Tehran.
Main outcome variables
Auditory and receptive language skills of hearing-impaired children under three years old
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220206053952N4
Registration date:2024-12-21, 1403/10/01
Registration timing:prospective
Last update:2024-12-21, 1403/10/01
Update count:0
Registration date
2024-12-21, 1403/10/01
Registrant information
Name
Farnoush Jarollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 0541
Email address
jarollahi.f@iums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of an auditory training program on improving auditory and language skills in hearing-impaired children under three years old, using maternal language instruction and parental emotional support.
Public title
Auditory training program for hearing-impaired children under three years old, using maternal language instruction and parental emotional support.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Congenital bilateral hearing loss, ranging in severity from moderate to profound.
Having hearing parents
Using bilateral hearing aids or cochlear implants
Having a full-term birth history.
Not having syndromes, vision impairments, or neurological conditions
No evidence of auditory neuropathy
The assistive listening device should be worn by the child at least 80% of their awake time
Participating in aural rehabilitation at Mother and Child Centers
Exclusion criteria:
Not doing homework assignments
Reluctance to continue participating in the study
Age
From 9 months old to 24 months old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
To evaluate participants' auditory and language skills, related questionnaires will be completed by an audiologist who does not know the group assignments. A statistician, blinded to the group assignments, analyzes the collected data to determine the program's effectiveness in developing aural and language skills in hearing-impaired children.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-11-09, 1403/08/19
Ethics committee reference number
IR.IUMS.REC.1403.664
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
Auditory training
Timepoint
Before the intervention, and at three and six months after it started.
Method of measurement
Persian version of the Infant Toddler-Meaningful Auditory Integration Scale (IT-MAIS)
Secondary outcomes
1
Description
Receptive language
Timepoint
Before the intervention, and at three and six months after it started.
Method of measurement
The Persian version of the Macarthur-Bates Communication Development Inventory
2
Description
Parents' self-efficacy
Timepoint
Before the intervention, and at three and six months after it started.
Method of measurement
Persian version of the Scale of Parental Involvement and Self-Efficacy–Revised (SPISE-R)
Intervention groups
1
Description
In addition to aural rehabilitation at the Mother and Child Centers, the intervention group will participate in an auditory training program. This program will include 24 individual sessions, each lasting 30 minutes, held weekly over six months. Additionally, a positive parenting program is designed to support parents of children with hearing loss. This program lasts eight weeks, with a weekly group session.
Category
Rehabilitation
2
Description
The control group will only receive aural rehabilitation from the Mother and Child Center.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasa Audiology Center
Full name of responsible person
Nasrin Gohari
Street address
Rasa Audiology Center, first floor of Mehmandoust Passage, Shohada Ave., Emam Khomeini square
City
Varamin
Province
Tehran
Postal code
3371813312
Phone
+98 912 332 7573
Email
fr.aslibeigi@gmail.com
2
Recruitment center
Name of recruitment center
Pejvak Audiology Center
Full name of responsible person
Reza Sadeghi
Street address
Pejvak Audiology Center, No. 86, Amini Alley, after passing Dariush Station, Damavand Street
City
Tehran
Province
Tehran
Postal code
16956783
Phone
+98 912 843 5609
Email
fr.aslibeigi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
falak.r@iums.ac.ir
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
Farideh Aslibeigi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation of Iran university of medical Sciences, Department of Audiology, Madakaran Ave., Shah Nazari Ave., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 6147 2348
Email
fr.aslibeigi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Frnoush Jarollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation of Iran university of medical Sciences, Department of Audiology, Madakaran Ave., Shah Nazari Ave., Madar Sq., Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2225 0541
Email
jarollahi.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farideh Aslibeigi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation of Iran university of medical Sciences, Department of Audiology, Madakaran Ave., Shah Nazari Ave., Madar Sq, Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 6147 2348
Email
fr.aslibeigi@gmail.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