Protocol summary

Study aim
The effect of Play Therapy on the attention and concentration and active memory in children with the attention deficit hyperactivity disorder
Design
The samples of this research include children with ADHD and randomly will be divided into experimental and control groups (20 persons in each group) and will complete continuous performance scale, active memory scale. Play therapy will be conducted during 8 sessions in experimental group while the control group will not receive any training.
Settings and conduct
Research place : personal counselor office Play therapy will be conducted during 8 sessions in 2 months for experimental group while the control group will not receive any training. Finally, after the intervention course, results will be compared.
Participants/Inclusion and exclusion criteria
All Children with ADHD in Rasht city
Intervention groups
Play therapy, named "See and Say", will be attended 1 session in a week for about 2 months (totally 8 sessions). Control group will receive no intervention but after measurement, it will be done for control group too, morally.
Main outcome variables
attention, concentration and active memory

General information

Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number: IRCT20190331043147N1
Registration date: 2020-02-04, 1398/11/15
Registration timing: retrospective

Last update: 2020-02-04, 1398/11/15
Update count: 0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Manizheh Hasanipour fallah
Name of organization / entity
University payame noor
Country
Iran (Islamic Republic of)
Phone
+98 13 3334 3658
Email address
m.hasanipour94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-04-04, 1398/01/15
Trial completion date
2019-04-04, 1398/01/15
Scientific title
The effect of play therapy on the attention and concentration and active memory in children the attention deficit hyperactivity disorder
Public title
play therapy in 6-years old children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
hyperactivity disorder and Attention deficit being 6 years old
Exclusion criteria:
continuous attention Mental disability less than 6 years old
Age
From 6 years old to 6 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, the researcher gives each individual in the community a special code or number (here the file number). (Some of the communities studied have numbered systems, such as students or students of a training center. Therefore, no coding is required and the researcher can base numbers on these lists.) Then use beads and plates on the numbers or write them on a small paper or cardboard; therefore, it will have the number of people in the community. Then they throw them into a bag or container and mess up. He then extracts the beads one by one, records their numbers, and continues this until they choose the number of sample numbers. Accordingly, here, 40 children with attention deficit hyperactivity disorder who were referred to the researcher's personal clinic were selected according to the inclusion criteria and randomly selected from a referral file number. They were divided into two experimental and control groups.
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
Guilan University of Medical Sciences
Street address
Dorsa building, Noorbakhsh St, Sabze-Meydan Sq, Rasht
City
Rasht
Province
Guilan
Postal code
4143775545
Approval date
2018-12-15, 1397/09/24
Ethics committee reference number
IR.GUMS.REC.1397.348

Health conditions studied

1

Description of health condition studied
attention deficit hyperactivity
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type

Primary outcomes

1

Description
attention and concentration
Timepoint
at the beginng, during the course and at the end after one month
Method of measurement
CPT

2

Description
active memory
Timepoint
at the beginng, during the course and at the end after one month
Method of measurement
WISC-IV

Secondary outcomes

empty

Intervention groups

1

Description
For Test group, The game "See and Say" which is a therapeutic package and includes a board game for hyperactive children, will be done. This game is suitable for treatment of attention and concentration problems. The time of hourglass is 30 seconds. The game will be played with 2 to 4 players and is suitable for children over 4 years. (Children who do not have the ability to read and write should also do it with an adult, because the questions behind the cards must be handled by someone who can read). This game contains 160 cards and 960 questions.
Category
Treatment - Other

2

Description
Control group: no specific training but playing the game in one session just for being familiar with.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Andisheh Novin
Full name of responsible person
Manizheh Hassani pourFallah Behdani
Street address
3rd floor, Pars Building, Motahari St
City
Rasht
Province
Guilan
Postal code
4184935174
Phone
+98 13 3334 3658
Email
m.hasanipour94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr nemati
Street address
in front of 17 Shahrivar hospital
City
rasht
Province
Guilan
Postal code
4193893345
Phone
+98 13 3333 6394
Email
medjour@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
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
Rasht University of Medical Sciences
Full name of responsible person
Manizheh Hassani pourFallah Behdani
Position
counselor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd floor, Pars building, Motahari St
City
rasht
Province
Guilan
Postal code
4184935174
Phone
+98 13 3334 3658
Email
m.hasanipour94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Manizheh Hassani pourFallah Behdani
Position
counselor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd floor, pars building, Motahari St
City
rasht
Province
Guilan
Postal code
4184935174
Phone
+98 13 3334 3658
Email
m.hasanipour94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Manizheh Hassani pourFallah Behdani
Position
counselor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd floor, Pars building, Motahhari St
City
rasht
Province
Guilan
Postal code
4184935174
Phone
+98 13 3334 3658
Email
m.hasanipour94@gmail.com

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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