Implementing a family-based educational interventional program to empowerment mothers of children suffering from hearing impairments to promote children's speech and mother's health status
This study is a double-blind clinical trial, with interventional and control groups. The subjects will be allocated in the groups using the blocked randomization method. The aim of this study is to evaluate the effect of a family-based educational interventional program on empowerment of mothers who own children suffering from hearing impairments to develop children's speech and improve the general health status of the mother.
The population of study contains mothers who own one to seven years old children with cochlear implantation. Inclusion criteria include Hearing ability of child's parents; Having a one to seven years old child with hearing impairment and speech problems; Mothers who have one child with hearing impairments; lack of other disabilities except hearing loss and speech disorder in children; Interested to participate in the study voluntarily. Exclusion criteria include Unwillingness to continue to participate during study; Lack of access to participants. The total sample size of the study will be 70 persons. The interventional training program will be based on empowerment of mothers and expected outcomes will be: Speech development in deaf children suffering from speech disorders and mothers' general health status development.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111230857N1
Registration date:2017-02-19, 1395/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Firoozeh Mostafavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8628
Email address
mostafavi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-16, 1394/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementing a family-based educational interventional program to empowerment mothers of children suffering from hearing impairments to promote children's speech and mother's health status
Public title
Designing and implementing a family-based educational interventional program to empowerment mothers of children suffering from hearing impairments to promote children's speech and mother's health status
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion criteria: The Hearing ability of child's parents; Having a one to seven years old child with hearing impairment and speech problems; Mothers who have one child with hearing impairments; lack of other disabilities except hearing loss and speech disorder in children; Interested to participate in the study voluntarily).
(Exclusion criteria: Unwillingness to continue to participate during study; Lack of access to participants)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Science Ethics Committee
Street address
Department of Health Education and Promotion, Faculty of Health, Isfahan University of Medical Science, Hezar Jarib Ave, Isfahan
City
Isfahan
Postal code
Approval date
2014-12-15, 1393/09/24
Ethics committee reference number
393789
Health conditions studied
1
Description of health condition studied
Speech Disorders
ICD-10 code
ّF80
ICD-10 code description
Specific developmental disorders of speech and language
Primary outcomes
1
Description
Speaking development
Timepoint
0-3-6 month
Method of measurement
Niosha questionnaire
Secondary outcomes
1
Description
The general health of mothers
Timepoint
0-1-3
Method of measurement
Questionnaire
Intervention groups
1
Description
"Intervention groups: Implementation of educational intervention program based on empowerment of mothers during training sessions at two speech therapy centers for deaf children"
Category
Behavior
2
Description
"Control group: Without action"
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Soroush Rehabilitation Center
Full name of responsible person
Zandi Zahra
Street address
Plague:5473, 9/6 Alley, Ninth Street, Western Golchin Ave, South Motahari Boulevard, Shiraz