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Evaluation of the efficacy of parent education for parents of children with diabetes type 1 on parental distress,parent-child interaction and child behavioral problems and diabetes management

Protocol summary

Study aim
the effectiveness of educating parents of children with type 1 diabetes in reducing parental stress, improving parent-child interaction, and reducing problems Child behavior and improving diabetic management
Design
A clinical trial with a control group, consecutive sampling among clients who were randomized using four blocks on 40 patients.
Settings and conduct
training course Weekly meetings are held at Hazrat Ali Asghar Hospital by subspecialist/assistant subspecialist in child and adolescent psychiatry and child and adolescent psychologist. The participants are placed in groups of 10 and during these sessions mothers use They gain the necessary knowledge and skills from practice, role playing and homework. Then, the final evaluation and completion of parenting stress questionnaire, hemoglobin C1A level and parental satisfaction level are done one month after the end of the treatment sessions. All questionnaires are also filled by the control group.
Participants/Inclusion and exclusion criteria
4-14 years old, diagnosed with type 1 diabetes in the past month, consent of the participants to participate in the program, child suffering from severe comorbid psychiatric disorders that require drug treatment, mental retardation , undergoing treatment Taking the parent for an underlying anxiety-depressive disorder during the research period
Intervention groups
Classes are conducted in 10 weekly 2-hour sessions by a child and adolescent psychiatrist/child and adolescent psychologist. Basic evaluations include completing questionnaires, as well as recording hemoglobin c1A results before the beginning of the training course and one month after the end of the treatment sessions.
Main outcome variables
Parent-child interaction, parental disturbance, child behavior problems, glycosylated hemoglobin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240101060588N1
Registration date: 2024-04-25, 1403/02/06
Registration timing: registered_while_recruiting

Last update: 2024-04-25, 1403/02/06
Update count: 0
Registration date
2024-04-25, 1403/02/06
Registrant information
Name
Narges Serajpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4881 5941
Email address
faribirzifar.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-06, 1403/01/18
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of parent education for parents of children with diabetes type 1 on parental distress,parent-child interaction and child behavioral problems and diabetes management
Public title
The effect of training parents with children with type 1 diabetes on parental stress, parent-child interaction, child behavior problems and diabetes management
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 4-14 years Diagnosed with type 1 diabetes in the past month Participants' consent to participate in the program
Exclusion criteria:
The child has severe comorbid psychiatric disorders that require drug treatment Mental retardation Undergoing treatment of the parent for underlying anxiety-depressive disorder during the study period
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
by using randomization with blocks of four (randomization block) to one of the two test groups (20 mothers with diabetic children for whom parent training sessions are conducted) and control (20 mothers with diabetic children who are considered as the control group and they don't get training in this field) enter.
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
Research Assistant - Study and Research Management System of Tehran University of Medical Sciences
Street address
Tower A4, Shahid Kharazi town., Ardestani Blvd., West Hamadani highway., Tehran
City
Tehran
Province
Tehran
Postal code
1497714822
Approval date
2024-01-08, 1402/10/18
Ethics committee reference number
IR.TUMS.EMRI.REC.1401.121

Health conditions studied

1

Description of health condition studied
diabetes type one
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

Primary outcomes

1

Description
Parent-child interaction
Timepoint
At the beginning of the study and after the completion of the training sessions
Method of measurement
Parental stress questionnaire

2

Description
Parental turmoil
Timepoint
At the beginning of the study and after the completion of the training sessions
Method of measurement
Parental stress questionnaire

3

Description
Child behavioral problems
Timepoint
At the beginning of the study and after the completion of the training sessions
Method of measurement
Parental stress questionnaire

4

Description
HbA1c
Timepoint
At the beginning of the study and after the completion of the training sessions
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mother with diabetic children For whom parent training sessions are held
Category
Behavior

2

Description
Control group: Mothers with diabetic children who are considered as the control group and do not receive education
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliasghar hospital
Full name of responsible person
Dr. Arghavan Friborzifar
Street address
Aliasghar child hospital,Zafar Ave, Modares highway, Tehran
City
Tehran
Province
Tehran
Postal code
02122222042
Phone
+98 21 2222 2045
Email
aachsv1@gmail.com

2

Recruitment center
Name of recruitment center
Endocrinology & metabolism research center of tehran university
Full name of responsible person
Dr. Ensie Nasli
Street address
Shahrivar street, Kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ensie nasli esfahani
Street address
Endocrinology and Metabolism Research Institute.,next to Dr. Shariati Hospital,. Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
emrc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Iranian academic center for education culture and research
Full name of responsible person
Narges Serajpour
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
A4 Tower., Shahid Kharazi town., Ardestani Blvd., Hamedani Gharb highway
City
Tehran
Province
Tehran
Postal code
1497714522
Phone
+98 21 4881 5941
Fax
Email
faribirzifar.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges Serajpour
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
A4 Tower., Shahid Kharazi town., Ardestani Blvd., Hamedani Gharb highway
City
Tehran
Province
Tehran
Postal code
1497714822
Phone
+98 21 4881 5941
Fax
Email
faribirzifar.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges Serajpour
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
A4 Tower., Shahid Kharazi town., Ardestani Blvd., Hamedani Gharb highway
City
Tehran
Province
Tehran
Postal code
1497714822
Phone
+98 21 4881 5941
Fax
Email
faribirzifar.a@iums.ac.ir

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
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the study will be presented without mentioning the personal data of the participants.
When the data will become available and for how long
The access period starts 6 months after the end of the plan
To whom data/document is available
Researchers of this project can access confidential data. Researchers from other universities can contact the person in charge of this project to learn about the protocol of holding training sessions.
Under which criteria data/document could be used
In this case, it is necessary to talk with the researcher and make a decision.
From where data/document is obtainable
Applicants can write to Ms. Narges Serajpour at nserajpour@gmail.com.
What processes are involved for a request to access data/document
After receiving the applicant's email, her/his request will be reviewed and a response will be given within two weeks.
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