Protocol summary

Study aim
the goal of this study was to survey the effectiveness of family-based cognitive-behavioral play therapy program on the symptoms of attention deficit hyperactivity disorder in children.
Design
The design used in this study was quasi-experimental with pre-test, post-test and control group. The sampling method was convenience. A total of 34 male students of the second grade of elementary school with the symptoms of ADHD -combined type- were selected by convenience sampling method
Settings and conduct
this study conducted in two elementary school in yazd city.. After designing the program of play therapy by the researcher, the mothers of the experimental group received 7 sessions of training on cognitive-behavioral games then performed them on their children for sixteen sessions at home, while the control group did not receive any training.
Participants/Inclusion and exclusion criteria
inclusion criteria: hisotry of not receiving cognitive-behavioral therapy exclusion criteria: inability to read and write
Intervention groups
After designing the program of play therapy by the researcher, the mothers of the experimental group received 7 sessions of training on cognitive-behavioral games then performed them on their children for sixteen sessions at home, while the control group did not receive any training.
Main outcome variables
symptoms of attention deficit and hyperactivity disorder

General information

Reason for update
Acronym
CBPT
IRCT registration information
IRCT registration number: IRCT20181104041548N1
Registration date: 2018-12-19, 1397/09/28
Registration timing: retrospective

Last update: 2018-12-19, 1397/09/28
Update count: 0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Abbas Motavalli pour
Name of organization / entity
Tehran university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 3436
Email address
abbas.mot@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey The Effectiveness of Family Based Cognitive-Behavioral Play Therapy Program on Symptoms of Attention Deficit and Hyperactivity Disorder in Children.
Public title
developing a cbpt
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
not receive cognitive-behavioral therapy (CBT)
Exclusion criteria:
inability to read and write
Age
From 10 years old to 12 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 17
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
aplied by mothers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of two educational district of Yazd
Street address
chamran street
City
yazd
Province
Yazd
Postal code
8915463456
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
34701-13

Health conditions studied

1

Description of health condition studied
ADHD
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type

Primary outcomes

1

Description
Symptoms of ADHD
Timepoint
post test and 3 month follow up
Method of measurement
Child Symptom Inventory-4 (CSI-4)

Secondary outcomes

empty

Intervention groups

1

Description
After reviewing the existent literature, need assessment, validation and pilot study, the program used in experimental phase. the mothers of the experimental group received 7 sessions (in seven weeks) of training on cognitive-behavioral plays then performed them on their children for 16 sessions (45 minutes) at home.the plays in present progarm consist of: session 1: eye to eye and snowballs. session 2: beat the clock. session 3: electrocardiogram making and guidance. session 4: beat the clock and say,do, say.session 5: opposite paires, snowballs and lax/iron doll. session 6: classmates. session 7: snowballs and coloring an snake. session 8: electrocardiogram making. session 9: post box and Treasure finding. session 10: color your life and corrective sentences. session 11: three whistle and Bubbleing. session 12: making a film and Treasure finding. session 13: the feeling word and corrective sentences. session 14: be careful, exam and cooking. session 15: color your life and who arrive sooner. session 16: who arrive sooner and Bubbleing.
Category
Other

2

Description
Control group: the control group did not receive any training.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
soheyli and meshkibaf schools
Full name of responsible person
Mr haji abedi
Street address
hasan abad
City
yazd
Province
Yazd
Postal code
8914536754
Phone
+98 35 3620 3436
Fax
+98 35 3620 3436
Email
abbas.mot@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Ahmad Beh pajooh
Street address
Dr. Kardan street. faculty of psychology and education
City
Tehran
Province
Tehran
Postal code
8913678967
Phone
+98 21 6111 7415
Fax
+98 21 6111 7415
Email
abbas.mot@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tehran
Proportion provided by this source
100
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
University of Tehran
Full name of responsible person
Abbas Motavalli Pour
Position
Ph,D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdi
City
Yazd
Province
Yazd
Postal code
8914747668
Phone
+98 35 3620 3436
Fax
+98 35 3620 3436
Email
abbas.mot@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Abbas Motavalli Pour
Position
Ph,D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdi
City
Yazd
Province
Yazd
Postal code
8914747668
Phone
+98 35 3620 3436
Fax
+98 35 3620 3436
Email
abbas.mot@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
university of tehran
Full name of responsible person
Abbas Motavalli Pour
Position
Ph,D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdi
City
Yazd
Province
Yazd
Postal code
8914747668
Phone
+98 35 3620 3436
Fax
+98 35 3620 3436
Email
abbas.mot@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
No - There is not a plan to make this available
Title and more details about the data/document
some portion of data
When the data will become available and for how long
2017
To whom data/document is available
psychologists
Under which criteria data/document could be used
nothing
From where data/document is obtainable
by email
What processes are involved for a request to access data/document
sending email
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