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Comparison of Filial and Child-Therapist play therapy on Attention and Hyperactivity of Children with ADHD

Protocol summary

Summary
The purpose of this study is comparison of filial and child-therapist play therapy on attention and hyperactivity of children with ADHD. Play is known as essential requirements for human (child). For children, play, same as food and water, is essential for survival, and also is one of important determinants of health and wellbeing. Meaningful games can severely affect human health and therefore the absence of these games can have destroying consequences to follow. Play is considered as a practical or actual tool for organizing time, place, and materials, patterns, habits and roles will develop through play. Children with ADHD, may make a lot of efforts to be successful in school, which can negatively affect their educational activities, for example it can disrupt their social activities in maintaining positive relationship with peers or may damage family relationships. Attention deficit disorder with hyperactivity is a childhood inherited chronic disorder of neural development. It is known by stable and recurring patterns of attention deficit, impulsivity and hyperactivity characteristics, which is inconsistent with developmental level of child. Play therapy is a method to help affected children for confronting with problems. This method is used as a tool for communication between child and therapist. This method is based on a fundamental assumption that play is a process by which child at first separate “me” from “not-me” and connects with world beyond self. Children communicate with their environment through play. At this study attempts are made to introduce play therapy as an effective method in treatment fields of children, and moreover to compare effectiveness of child-family method with child-therapist method with each other and to report their effectiveness on children with ADHD. This is an experimental study, the target population is children with ADHD, aged 6 to 12 years old, and who were referred to clinical centers of IRAN University of Medical Sciences. Sampling is random, by the way of randomly permuted blocks in available population.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013111615416N1
Registration date: 2015-06-22, 1394/04/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Hooshang Mirzaie
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 5765
Email address
h-mirzaie@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-02-09, 1392/11/20
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Filial and Child-Therapist play therapy on Attention and Hyperactivity of Children with ADHD
Public title
The Effects of Play Thrapy on chidren with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 - Diagnosis of Attention Deficit - Hyperactivity by a psychiatrist. 2 - Age between 6 to 12 years old. 3 - Parent's willingness to participate in research and educational group sessions and the ability to record meetings. 4 - At least high school levels of education for parents. 5 - Lack of mental retardation. 6 - Accepting filming sessions (for children - the therapist and the child - parent), by legal guardian. 7 - Make the necessary scale score CSI-IV. 8 - Absence of comorbid disorders (LD, ODD, ...). Exclusion criteria: 1 - There are significant problems with physical, sensory or motor. 2 - There are obvious signs of psychosis in children. 3 - Having certain diseases or disorders (autism, Davvn syndrome, genetic disorders, etc.). 4 - Significant history of drug abuse, child or parent. 5 - History of seizures and related drugs. 6 - Lack of parental consent to participate in the study or to continue. 7 - Parents suffering mental illness.
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: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Copmarison of two methods of play therapy and their effects on children with ADHD

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Tehran University of Medical Sciences, Keshavarz Blv.
City
Tehran
Postal code
Approval date
2013-11-04, 1392/08/13
Ethics committee reference number
1679/130/د/92

Health conditions studied

1

Description of health condition studied
Attention Deficit/Hyperactivity Disorder in Children
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Attention deficit and Hyperactivity
Timepoint
Three Months After Intervention
Method of measurement
Child Symptom Inventory-4 (CSI-4) and Test of Everyday Attention for Children

Secondary outcomes

1

Description
Parenting Stress
Timepoint
Three montes After Intervention
Method of measurement
Parenting Stress Index (PSI)

Intervention groups

1

Description
Filial Therapy Intervention. Filial therapy is a short-term treatment approach which combines play therapy with family therapy. Therapist trains family and monitors their activities. Parents conduct child-centered play therapy sessions with their children. Most of these meetings at home without direct supervision of a therapist.
Category
Rehabilitation

2

Description
Adlerian Play Therapy Intervention. Child-centered play therapy (Adlerian) was done in a fully equipped play therapy center (at a specific time and place), which was equipped by variety of toys. This group received 30 sessions child-therapist intervention (45 minutes to 1 hour for 10 weeks, 3 days per week).
Category
Rehabilitation

3

Description
Without Intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Occupational Therapy Clinic, Rehabilitation School of Iran University of Medical Science
Full name of responsible person
Prof. Asoon Hasani Mehraban
Street address
Rehabilitation School of Iran University of Medical Science, Modar Square, Mirdamad st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rehabilitation School of Iran University of Medical Sciences
Full name of responsible person
Prof. Mojtaba Kamyab
Street address
Teharn, Mirdamad avenue, Madar square, Shahid Shah-Nazari street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehabilitation School of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hooshang Mirzaie
Position
PhD of Occupational Therapy
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat high way
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
hooshang_mirzaie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hooshang Mirzaie
Position
PhD of Occupational therapy
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat high way
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
hooshang_mirzaie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hooshang Mirzaie
Position
PhD of Occupational Therapy
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat High way
City
Teharn
Postal code
Phone
+98 21 2222 8051
Fax
Email
hooshang_mirzaie@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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