Protocol summary

Study aim
The aim of this study is to find a more effective method between the two educational interventions of parenting and life skills so that by expanding and teaching this method, an effective action can be taken for mothers with children with hearing loss.
Design
Clinical trial with parallel control group, single blind, randomized with Excel software
Settings and conduct
Due to the limitations of COVID-19 disease epidemic, this study will be through the provision of virtual content (audio-video) with question and answer sessions for each training session. Therefore, participants will participate in this training in the form of WhatsApp or Skype groups. Each week, one and sometimes two training sessions are held and during the week, the trainings will be followed by two-way questions and answers between the instructor and the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a child with hearing loss; absence of any psychiatric disorders requiring treatment with psychiatric drugs in the child; the age of the child should be 3-7 years old. Criterion for not entering the research: not one of the mothers referring to Soroush Rehabilitation Center
Intervention groups
After random assignment of people in two groups, participants will be assessed with a mental health questionnaire before and after the test to evaluate the main variable. Also, to evaluate the effectiveness of educational interventions, questionnaires appropriate to the educational intervention will be completed by the relevant group before and after the test. Also, in order to prevent the effect of overlapping educational interventions, the skills group of the other group will be answered by both groups before and after Amon.
Main outcome variables
Mothers' level of mental health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201014049023N1
Registration date: 2020-10-23, 1399/08/02
Registration timing: retrospective

Last update: 2020-10-23, 1399/08/02
Update count: 0
Registration date
2020-10-23, 1399/08/02
Registrant information
Name
moamad abdan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4372 4051
Email address
abdan.m74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-15, 1399/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of parenting training with life skills training on the mental health of mothers of children with hearing loss
Public title
Comparing the effectiveness of parenting training with life skills training on the mental health of mothers of children with hearing loss
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with hearing loss Absence of any psychiatric disorders requiring treatment with psychiatric drugs in the child The age of the child is 3-7 years old
Exclusion criteria:
Do not refer to Soroush Rehabilitation Center
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
First, the participants were coded individually. Then, based on simple randomization and with the help of a table of random numbers, even numbers were considered for one intervention and odd numbers for the other intervention. Then, the type of intervention was assigned to each group by lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness were conducted for participants in a one-way manner. In this way, the participants are not aware of the title of the training method they receive and its difference from the training method provided to the other group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of Shiraz Medical School
Street address
Shiraz Medical Schoo, lZand St.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.SUMS.MED.REC.1399.369

Health conditions studied

1

Description of health condition studied
Mothers of children with hearing loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral

Primary outcomes

1

Description
General Health Questionnaire Score
Timepoint
One week before and after starting educational interventions
Method of measurement
Genaral Health Questionnaire

Secondary outcomes

1

Description
Quality of life score
Timepoint
One week before and after educational interventions
Method of measurement
General Health Questionnaire

2

Description
Depression score
Timepoint
One week before and after educational interventions
Method of measurement
General Health Questionnaire

3

Description
Anxiety score
Timepoint
One week before and after educational interventions
Method of measurement
General Health Questionnaire

4

Description
Physical symptoms score
Timepoint
One week before and after educational interventions
Method of measurement
General Health Questionnaire

Intervention groups

1

Description
First intervention group: a group that receives parenting skills training; During a ten-session workshop on parenting education, this group sees positive parenting in a positive way
Category
Lifestyle

2

Description
Second intervention group: a group that receives life skills training; The well-known life skills program will be held as a ten-session detective, in which one of the ten skills will be taught to mothers.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Soroush Rehabilitation Center Shiraz
Full name of responsible person
Maryam Wahab
Street address
6th Alley-9th Street-west gholchin street-south motahari boulevard
City
shiraz
Province
Fars
Postal code
7194684695
Phone
+98 71 3842 4123
Email
abdan.m74@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaeianzadeh
Street address
Zand Street - Opposite Palestine Street
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Dehbozrgi
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shiraz, Chamran St., Abivardi beginning, Hafez Educational and Medical Center, Office of Psychiatry
City
Shiraz
Province
Fars
Postal code
3478671946
Phone
+98 71 3647 9319
Email
dr.dehbozorgi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Dehbozorgi
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shiraz, Chamran St., Abivardi beginning, Hafez Educational and Medical Center, Office of Psychiatry
City
Shiraz
Province
Fars
Postal code
3478671946
Phone
+98 71 3647 9319
Email
dr.dehbozorgi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Dehbozorgi
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shiraz, Chamran St., Abivardi beginning, Hafez Educational and Medical Center, Office of Psychiatry
City
Shiraz
Province
Fars
Postal code
3478671946
Phone
+98 71 3647 9319
Email
abdan.m74@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participants' data can be shared after not identifying individuals
When the data will become available and for how long
After publishing the final article
To whom data/document is available
All
Under which criteria data/document could be used
There will be no restrictions on the commitment to confidentiality
From where data/document is obtainable
Library of Shiraz Medical School
What processes are involved for a request to access data/document
Medical school library approval
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