The effect of group play therapy on emotional behavioral problems in children with attention deficit hyperactivity disorder (ADHD) aged 6-12 years
Design
Clinical trial with control group
Settings and conduct
After obtaining the necessary permits from the University of Social Welfare and Rehabilitation Sciences, children with a diagnosis of attention deficit hyperactivity disorder were selected by a psychiatrist who was referred to the TOHID Child Care Clinic in Isfahan. The parents first filled out the child morbidity questionnaire. Children with ADHD were selected for the intervention. After completing the consent form, the selected subjects filled out a demographic questionnaire and were initially evaluated for child behavioral logs and the results were recorded by the researcher. By random selection, indoor cards were divided into two intervention or control groups.
Intervention group in addition to receiving daily educational services, participated in 12 sessions of group play intervention (6 weeks, 2 sessions per week and 45-60 minutes per session), but the control group received only daily educational and mental health services (subjective occupational therapy). And physical, speech therapy). After 12 sessions, the parents' questionnaire was again filled out by the parents.
Participants/Inclusion and exclusion criteria
6-12 year old children with attention deficit hyperactivity disorder
Intervention groups
Intervention group in addition to receiving daily educational services, participated in 12 sessions of group play intervention (6 weeks, 2 sessions per week and 45-60 minutes per session), but the control group received only daily educational and mental health services (subjective occupational therapy). And physical, speech therapy).
Main outcome variables
Reducing emotional and behavioral problems in children with attention deficit hyperactivity disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190924044875N1
Registration date:2019-10-14, 1398/07/22
Registration timing:prospective
Last update:2019-10-14, 1398/07/22
Update count:0
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Sepide Teimourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 2578
Email address
sepide.teimourian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2019-11-27, 1398/09/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group play therapy on emotional behavioral problems of children with attention deficit hyperactivity disorder (ADHD) aged 6-12 years
Public title
The effect of group play therapy on emotional behavioral problems
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a child psychiatrist (based on medical records).
Completion of written consent of parents to participate in the research.
Age between 6 and 12 years based on year of birth listed in the file
Higher score of child behavioral inventory questionnaire than cut-off point (score 65) (completed by therapist).
Absence of psychotic symptoms in the child (CSI-4 test) (performed by the therapist).
Absence of obvious physical, sensory, or motor disorders (based on medical records)
Lack of history of seizures and use of related drug therapy (based on medical records).
No previous record of participation in similar studies.
Exclusion criteria:
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method using a sealed envelope.
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
Ethics committee of university of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.USWR.REC.1397.089
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
Emotional Behavior Problem Score in Child Behavior Check List
Timepoint
Evaluation of emotional behavior problems score at baseline (before intervention) and 6 weeks after intervention in group play therapy.
Method of measurement
Child Behavioral Check List
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In addition to individual occupational therapy and speech therapy, the group received group play intervention for 12 sessions, twice a week, each session lasting between 45 and 60 minutes. Each session is played in groups to control emotional-behavioral problems.
Category
Behavior
2
Description
Control group: the group does not receive group play intervention but attend other sessions including occupational therapy and speech therapy if needed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dostdaran kodak Tohid clinic
Full name of responsible person
Mahdi Parsa
Street address
Khaghani Crossroad, Middle Vahid Ave
City
esfahan
Province
Isfehan
Postal code
8175800000
Phone
+98 31 9501 0222
Email
tohidclinic@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Reza Khodaei Ardakani
Street address
University of social welfare and rehabilitation sciences, Koodakyar End, Daneshjoo Blv, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2832
Email
kh.ardakani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Sepide Teimourian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 78, Rashtchi Alley, Niknafs Alley, Vahid Ave
City
Esfahan
Province
Isfehan
Postal code
8175836461
Phone
+98 31 3629 2578
Fax
Email
sepide.teimourian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Houshang Mirzaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Koodakyar End, Daneshjoo Blv, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
ho.mirzaie@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Houshang Mirzaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Koodakyar End, Daneshjoo Blv, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
ho.mirzaie@uswr.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
Only for general study data, including its main implications, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Study data will be available only to researchers working in academic institutions.
Under which criteria data/document could be used
Use of data is permitted solely for the purposes of further study and information of applicants.