1. Home
  2. Approved trials
  3. » فارسی

Preparation and Study of the effecacy of mindfulness-based training package to improve attention, self-regulation and interpersonal relationships in Elementary School students with ADHD symptoms.

Protocol summary

Study aim
Prepare a mindfulness-based educational package for children with attention deficit hyperactivity disorder and then study its effectiveness for the same statistical population.
Design
Using the available sampling method, 15 students with symptoms of attention deficit hyperactivity disorder are selected, Then they fall into a group called the intervention group and first taken pre test from students and then They will be taught mindfulness-based training packages, then taken post test from students,The pre-test and post-test results will be compared.
Settings and conduct
Statistical population includes fourth, fifth and sixth grade elementary school students with symptoms of attention deficit / hyperactivity disorder, Intervention at Tasnim Elementary School, first taken pre test from student and Then the intervention will be done and then taken post test, So that we can compare pre-test and post-test
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elementary school students with attention deficit hyperactivity disorder,Gender:male Exclusion criteria: having a mental disorder at the same time not being at the same time under psychological treatment
Intervention groups
With informed consent, 15 children with symptoms of attention deficit / hyperactivity disorder were selected and Fall into one group then taken pre-test and then They will be taught mindfulness-based training packages, then taken post test from students,The pre-test and post-test results will be compared.If effective, the intervention will improve the symptoms of students with attention deficit hyperactivity disorder.
Main outcome variables
attention,self regulation,interpersonal relationship

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200303046687N1
Registration date: 2020-04-06, 1399/01/18
Registration timing: prospective

Last update: 2020-04-06, 1399/01/18
Update count: 0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
parnian rezaei
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7623 1872
Email address
pa.rezaee@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and Study of the effecacy of mindfulness-based training package to improve attention, self-regulation and interpersonal relationships in Elementary School students with ADHD symptoms.
Public title
Preparation and Study of the effecacy of mindfulness-based training package to improve attention, self-regulation and interpersonal relationships in Elementary School students with ADHD symptoms.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children 10 to 12 years old with symptoms of attention deficit hyperactivity disorder Gender: Male
Exclusion criteria:
having a mental disorder at the same time not being at the same time under psychological treatment
Age
From 10 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Shahid Beheshti Universityy
Street address
Institute of Cognitive and Brain Sciences, Shahid Beheshti University, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.SBU.REC.1398.041

Health conditions studied

1

Description of health condition studied
Attention-deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Attention
Timepoint
before the intervention, two week after the intervention
Method of measurement
Strop test

2

Description
self-regulation
Timepoint
before the intervention, two week after the intervention
Method of measurement
ERQ-CA

3

Description
Interpersonal Relationships
Timepoint
before the intervention, two week after the intervention
Method of measurement
Child Self-efficacy Questionnaire in Interpersonal Relationships with Peers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: mindfulness-based training package for eight 45-minute sessions for the intervention group,First, this package is tailored for elementary school student,Before the intervention, we will pre-test to determine the baseline level of children, and Then we will do mindfulness-based intervention and then we take the post-test so we can compare it with the pre-test, If this package is effective, it will improve the performance of children with ADHD.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Tasnim School
Full name of responsible person
Rahim porhashemi
Street address
Tasnim School., Sahar Ave., Sepah St
City
Pardis
Province
Tehran
Postal code
1655113592
Phone
+98 21 7670 2824
Email
parirez309@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid beheshti University
Full name of responsible person
Babak Shokri
Street address
Deputy Director of Research and Technology, Presidential Building, Shahid Beheshti University, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
drbabakshokri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti University
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
Shahid Beheshti University
Full name of responsible person
Jalil fath abadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Velenjak St
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2233
Email
parirez309@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Parnian Rezaei
Position
MS
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Velenjac St
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 7623 1872
Email
parirez309@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Parnian Rezaei
Position
MS
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Velenjac St
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 7670 2824
Email
parirez309@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The participants data without identifying information will be available after completion of the study. Clinical study report: The clinical study report will be available after completion of the study.
When the data will become available and for how long
September 2020
To whom data/document is available
For researchers and students
Under which criteria data/document could be used
Using study data for systematic reviews and meta-analysis studies is permitted.
From where data/document is obtainable
Dr Jalil fath abadi.Shahid beheshti university
What processes are involved for a request to access data/document
parirez309@gmail.com
Comments
Loading...