The purpose of this study is to evaluate the efficacy of play therapy on anxiety and aggression in preschool and elementary school children with ADHD disorder. This is an interventional study with control group. Participants have diagnosed ADHD disorder aged 6-11 years that last at least 3 months of receiving them medication. Also participants should not have other significant disorders in physical and psychological conditions. Participants are divided into two groups, experimental and control based on randomization list. The method of sampling is in accessible and is among individuals who have been referring to the Motahhary clinic, Esfahan, Iran. The intervention in this study is playing therapy that include 4 types of individual play and 4 type of collection play at period 8 week, 1 session a week. Pre-test and post-test to measure scale children anxiety and aggression by Questionnaire. Pre-test is conduct for both groups then post-test is conduct for both groups also through 2 stage (8 week after to start intervention and 1 month after to end intervention).
General information
Acronym
ADHD
IRCT registration information
IRCT registration number:IRCT2014090819086N1
Registration date:2014-11-20, 1393/08/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-20, 1393/08/29
Registrant information
Name
Parisa Doodman
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
doodman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of play therapy on anxiety and aggression in preschool and elementary school children with Attention Deficit Hyperactivity Disorder
Public title
Effect of play therapy on ADHD children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 6 to 11 years old; entry into preschool or elementary schools; diagnosis of attention deficit disorder / hyperactivity, according to psychiatrist; willingness to participate in the study (by agreeing with parental consent); children who are going at least 3 months of drug treatment; at least a fifth grade education for parents of children and lack of significant psychiatric disorders in order to complete questionnaire.
Exclusion criterion: child having any other significant disorder in physical or mental conditions.
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
Approval date
2014-10-25, 1393/08/03
Ethics committee reference number
CT-9374-7184
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, 8 weeks after the begining of intervention, one month after the end of intervention.
Method of measurement
Questionnaire
2
Description
Aggression
Timepoint
Before the intervention, 8 weeks after the begining of intervention, one month after the end of intervention.
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention in the intervention group is play therapy. 8 type individual and group plays are conducted with each child at period 8 week.
Category
Behavior
2
Description
Intervention in control group is no action.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari clinic
Full name of responsible person
Dr. Mojgan Karahmadi
Street address
Sepahsalar street, Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Poostforosh Fard
Street address
Seventh floor, Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Parisa Doodman
Position
MSc Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, front Felestine Street, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
doodman@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Alavi Shooshtari
Position
Assistant prof.
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, front Felestine Street, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
alialavi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Parisa Doodman
Position
MSc Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, front Felestine Street, Zand Street
City
Shiraz
Postal code
71348 14336
Phone
+98 71 3230 5410
Fax
+98 71 3212 2430
Email
doodman@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)