The purpose of this study was to determine the effectiveness of child-centered play therapy on internalization and extrapolation behavioral problems of children with cerebral palsy
Design
The clinical trial of the study had a control group, community-based and pragmatic, with parallel groups, single blind, simple randomized, and individualized
Settings and conduct
Rofideh Rehabilitation and Maintenance Center in Tehran.
First sessions were used to build a relationship between the child and the therapist. Sessions 4-12: the child discussed his problems through the game, and the therapist tried to give the child enough insight without trying to impose a subject on the child or directing their behavior to a particular direction, Sessions 12-16: Children were getting ready for finalzing treatment.
Participants/Inclusion and exclusion criteria
Children aged 6-8 years, the existence of emotional and behavioral problems based on Child Behavior Checklist، Interest in cooperation and participation in research، IQ above 55 ،No other treatments other than medication, ability to use language and speech, Uncontrollable aggression, absence more than twice a week, receiving other interventions at the time of study other than medication.
Intervention groups
Experimental group: sessions for 45 minutes, twice a week by researcher, control group: no intervention.
The effectiveness of child-centered play therapy on internalization and extrapolation behavioral problems in children with cerebral palsy
Public title
The effectiveness of child_centred play therapy on internalization and extrapolation behavioral problems in children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6-8 years, the existence of emotional and behavioral problems based on Child Behavior Checklist
Interest in cooperation and participation in research based on the written consent of the legal guardian
IQ is above 55 (based on the information recorded in the medical records available at the center) the lowest IQ is 55 and the highest is 70 and the average IQ is 62.5
No treatments other than medication
The ability to use language and speech,
Inserting the cerebral palsy injury in the medical file,
The relative ability for using hands in the game according to the type of injury stated in the medical file and possibility of using evaluations like muscle tonicity, the growth of reflexes, status evaluation and movement of the daily activities recorded in the occupational therapy file
Exclusion criteria:
Uncontrollable aggression
absence for more than twice a week
receiving other interventions at the time of study other than medication
Age
From 6 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization method was used in this study. In this method, there is the probability of inequality of the subjects assigned to each of the groups, especially in studies with small sample size. Due to the small sample size, instead of using random numbers table, randomization method was assigning the members of the population on a piece of paper and placing it inside a box, and then removing the papers one by one until the desired volume is filled out.
In addition, to ensure the correctness of using simple randomization, besides the previous method, randomization production software was used.
Random Allocation Software
Producing the random sequence: besides the above methods run, online website - WWW.Randomization.com – was used as well.
In order to hide the random assignment, one of its methods called the central randomization was used where the random sequence method was used. The researcher contacted the relevant center according to the order of entry of the participants to the study and asked questionsabout the random assignment of the participants. For selecting the sample, 30 children - boys and girls - aged 6-8 years old with a mean age of 7 years, were selected with cerebral palsy diagnosis of paraplegia type and mild to moderate monoplegia and then the sample group was randomly divided into two groups of 15 as control and experimental group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the main researcher who was involved in the intervention, among the other two researchers, knew which participant received which intervention. Thus, single-blind method was used and given the age and the IQ of the children and considering the ethical principles, a brief explanation of the game was given regard the game.However, the principal of the center, the maternity clinic and the center-based pediatrician were kept blind relative to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee Islamic Azad University- Science and Research Branch
Street address
Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2018-10-31, 1397/08/09
Ethics committee reference number
IR.IAU.SRB.REC.1397.078
Health conditions studied
1
Description of health condition studied
Internalization and extrapolation behavioral problems
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Child Behavior Checklist
Timepoint
Before the intervention, 3 months later and 6 months later
Method of measurement
Children behavioral behavior questionnaire in pre-test and post-test
2
Description
Anxiety Score in Children's Behavioral Problems Questionnaire
Timepoint
Before the intervention, 3 months later and 6 months later
Method of measurement
Children behavioral behavior questionnaire in pre-test and post-test
3
Description
Aggression Score in Children's Behavioral Problems Questionnaire
Timepoint
Before the intervention, 3 months later and 6 months later
Method of measurement
Children behavioral behavior questionnaire in pre-test and post-test
4
Description
Breaking down Score in Children's Behavioral Problems Questionnaire
Timepoint
Before the intervention, 3 months later and 6 months later
Method of measurement
Children behavioral behavior questionnaire in pre-test and post-test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The sessions of the experimental, groups were held in 16 sessions (12 individual sessions and 4 group sessions), for 45 minutes and twice a week done by the researcher.Thechild-centered intervention approach where the child managed the therapy-session and the therapist was as the facilitatorusing different classificationsof toys given to the children.They help the child to gain an insight of themselves, self-control and appropriate emotional outburst.
Category
Treatment - Other
2
Description
Control group: they received no child-centered game therapy intervention and receivedroutine care along no additional work.The researcher also committed to the intervention for the control group at the end of the intervention period and, if it is effective, and if desired, the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofeideh Rehabilitation and Maintenance Center
Full name of responsible person
Nasim Haghgou
Street address
Qaytrieh Street - Shahid Baradaran Soleymani - Nemati Avenue
City
Tehran
Province
Tehran
Postal code
1011234567
Phone
+98 21 2223 2741
Fax
+98 21 2223 3017
Email
rofeideh.hospital@uswr.ac.ir
Web page address
http://rofeideh.uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Seyed Ali Abtahi
Street address
Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5154
Fax
+98 21 4486 5179
Email
Srbiau@ac.ir
Web page address
http://std2.srbiau.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Science and Research Branch
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Samira Vakili
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Science and Research Branch - Shahdia Hesarak Blvd - University Square - End of Shahid Sattari Highway - Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5154
Email
Samiravkl@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sogand Ghasemzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5154
Email
S.ghasemzadeh@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samira Vakili
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5154
Email
samiravkl@yahoo.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
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
Not applicable
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
After the publication of the article, only a part of the data is related to the main consequence
When the data will become available and for how long
In 1398 and 3 months, he published a paper
To whom data/document is available
Only available to scholars working in academia and academia
Under which criteria data/document could be used
People who choose this approach and plan to test other issues
From where data/document is obtainable
By email with article authors
samiravkl@yahoo.com
S.ghasemzadeh@ut.ac.ir
yasamanshahriari@yahoo.com
What processes are involved for a request to access data/document
The method of intervention, the experimental group, the place of execution, and the dependent variables and the research outline for the authors, along with the signed letter of the authors of the proposed plan