Protocol summary

Study aim
Determination the Effect of Mindfulness-Based Education on the Burden of Care and Psychological Capital of Parents of Children with ADHD.
Design
Convenience sampling was used to select the participants among the parents of children ADHD referring to Zare Hospital. Then will be selected using the excel software Randbetween function.To put the samples in one of two group (intervention or group),the coin will be used.finally,they will be divided into two groups of 40 intervention and control.
Settings and conduct
The intervention group will attend eight 90-minute sessions twice a week at a classroom in Zare Hospital equipped with audio- visual instruments. The researcher will teach them Mindfulness and at the end of the eighth session after receiving the last training, both groups will be re-evaluated.
Participants/Inclusion and exclusion criteria
Entry criteria: Age of parents 18 to 65 years old, Having a child of 3 to 12 years old with ADHD ,Passing of at least 6 months after diagnosis of a child's illness by a psychiatrist, No severe mental illness in the parent's, Willingness participate in the study by the main parent (father/ mother or both) ,Ability to speak and read and write in Persian ,Not being under the psychotherapy simultaneously . Exclusion criteria :Simultaneous care for another patient in the family by the parent, Absence from more than two sessions , Reluctance to continue collaborating in the study ,Coincidence of other illnesses along the ADHD for the child.
Intervention groups
The intervention group receive eight 90-minute sessions of Mindfulness-Based Education twice a week while the control group will receive no specific intervention and will receive routine treatment.
Main outcome variables
the Burden of care and Psychological Capital

General information

Reason for update
Acronym
اختلال کم توجه/بیش فعال با حروف ADHD
IRCT registration information
IRCT registration number: IRCT20180924041109N1
Registration date: 2018-11-21, 1397/08/30
Registration timing: registered_while_recruiting

Last update: 2018-11-21, 1397/08/30
Update count: 0
Registration date
2018-11-21, 1397/08/30
Registrant information
Name
Yadollah Jannati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 9808
Email address
jannati.yadollah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness-Based Education on the Burden of care and Psychological Capital of Parents of Children with ADHD.
Public title
Mindfulness on the Burden of care and Psychological Capital of Parent
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of parents 18 to 65 years old Having a child of 3 to 12 years old with ADHD Passing of at least 6 months after diagnosis of a child's illness by a psychiatrist No severe mental illness in the parent's Willingness participate in the study by the main parent (father/ mother or both) Ability to speak and read and write in Persian Not being under the psychotherapy simultaneously
Exclusion criteria:
Simultaneous care for another patient in the family by the parent Absence from more than two sessions Reluctance to continue collaborating in the study Co-infection of the child with other illnesses Coincidence of other illnesses along the ADHD for the child
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible names were prepared and then the groups were selected using the Rand Between in Excel (a function that determines random numbers in a specified range). In order to assign the samples in either control or intervention group, we used tossing a coin.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
•Ethics committee of Mazandaran University of Medical Sciences
Street address
Teachers 'Street - Teachers' Square - Deputy of Research and Technology of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2018-08-12, 1397/05/21
Ethics committee reference number
IR.MAZUMS.REC.1397.151

Health conditions studied

1

Description of health condition studied
Attention Deficit Hyperactivity Disorder(ADHD) childeren
ICD-10 code
ICD-10 code description
F90-0

Primary outcomes

1

Description
The Score of Psychological Capital in the Luthanz Questionnaire
Timepoint
Before and immediately after the intervention
Method of measurement
Psychological Capital Luthanz Questionnaire

2

Description
The Score of Burden of care in the Zarit questionnaire
Timepoint
Before and immediately after the intervention
Method of measurement
Zarit questionnaire

Secondary outcomes

1

Description
self-efficacy
Timepoint
Before and immediately after the intervention
Method of measurement
Luthanz Psychological Capital questionnaire

2

Description
optimism
Timepoint
Before and immediately after the intervention
Method of measurement
Luthanz Psychological Capital questionnaire

3

Description
hope
Timepoint
Before and immediately after the intervention
Method of measurement
Luthanz Psychological Capital questionnaire

4

Description
flexibility /elasticity
Timepoint
Before and immediately after the intervention
Method of measurement
Luthanz Psychological Capital questionnaire

Intervention groups

1

Description
Intervention group:will receive eight 90-minute sessions of Mindfulness-Based Education twice a week.
Category
Other

2

Description
Control group: will receive no specific intervention and will receive routine treatment.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare hospital
Full name of responsible person
jannati yadollah
Street address
Sari Neka Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3328 3886
Fax
+98 11 3336 2569
Email
zarehospital@yahoo.com
Web page address
http://zarehospital.mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Sari, Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Fax
+98 11 3336 2569
Email
mazums.ac.ir@yahoo.com
Web page address
https://www.mazums.ac.ir
Grant name
------------
Grant code / Reference number
-----------------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
70
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

2

Sponsor
Name of organization / entity
Zare hospital
Full name of responsible person
Majid Saeedi
Street address
5 Sari Road, Neka
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3328 3886
Fax
+98 11 3326 8915
Email
zarehospital@yahoo.com
Web page address
http://zarehospital.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zare hospital
Proportion provided by this source
30
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
Mazandaran University of Medical Sciences
Full name of responsible person
Yadollah Jannati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amirmazandarani- vesal
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3310 9808
Fax
+98 11 3226 8915
Email
jannati.yadollah@gmail.com
Web page address
http://www.mazums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yadollah Jannati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amirmazandarani- vesal
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3310 9808
Fax
+98 11 3226 8915
Email
jannati.yadollah@gmail.com
Web page address
http://www.mazums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yadollah Jannati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amirmazandarani- vesal
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3310 9808
Fax
+98 11 3226 8915
Email
jannati.yadollah@gmail.com
Web page address
http://www.mazums.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
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
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