Investigating the effect of consultancy of play therapy on social evolution (social maturity) of 12-24 months old children referring to selected comprehensive health centers in Kashan 1396-1397
The aim of this study is investigating the effect of consultacy of play therapy on social evolution (social maturity) of 12 to 24 months old children referring to selected comprehensive health centers in Kashan.
Design
]n this study, 76 children from 12 to 24 months old who have been admitted to the study who visit the comprehensive health centers of the city of Kashan, are selected, and the social maturity scale is completed, if their score is less than half the full score. The randomization is divided into two groups of intervention and control and each participant is assigned a code.
Settings and conduct
The sampling method will be multistage, so that: firstly, three centers will be selected from the centers of the township, and in each center, according to the population of children aged one to two, available sampling according to the criteria for entering the research will be done. After selecting eligible individuals, they are randomly assigned to two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria The parents have at least literacy to read and write, be Iranian, 12 - 24 months old children whose age is Based on social growth scale, be at least one second year less than their calendar age, The child does not have known physical and mental illness, Parents’ Satisfaction to Participate in the Study and Exit criteria Mothers' reluctance to continue to participate in the study, not attending maximum two sessions of consultancy sessions of play therapy, having any kind of physical and mental disabilities.
Intervention groups
Intervention group In this group, in addition to routine child care training and delivery of training packages, 6 sessions that are 30 minutes and weekly 2 sessions of group consultancy of play therapy will be held,Control group they will receive ministry’s routine training and training packages.
Main outcome variables
Increase the developmental score of children from 12 to 24 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027728N7
Registration date:2018-01-11, 1396/10/21
Registration timing:prospective
Last update:2018-01-11, 1396/10/21
Update count:1
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of consultancy of play therapy on social evolution (social maturity) of 12-24 months old children referring to selected comprehensive health centers in Kashan 1396-1397
Public title
Investigating the effect of consultancy of play therapy on social evolution (social maturity) of 12-24 months old children referring to selected comprehensive health centers in Kashan 1396-1397
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The parents have at least literacy to read and write
12 - 24 months old children whose age is Based on social growth scale, be at least one second year less than their calendar age
be Iranian
The child does not have known physical and mental illness
Parents’ Satisfaction to Participate in the Study
Exclusion criteria:
Mothers' reluctance to continue to participate in the study,
not attending maximum two sessions of consultancy sessions of play therapy,
having any kind of physical and mental disabilities.
Age
From 12 months old to 24 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling and random blocks
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
Alborz University Of Medical Sciences
Street address
ninth floor, Dara building, north Yasmin, east Pune street, 45 Yards of Glshahr, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2017-12-30, 1396/10/09
Ethics committee reference number
Abzums.Rec.1396 .136
Health conditions studied
1
Description of health condition studied
The social development of children 12-24 months
ICD-10 code
Z31.6
ICD-10 code description
Encounter for general counseling and advice on procreation
Primary outcomes
1
Description
Social maturity of the child in Vineland scale
Timepoint
Before intervention and at the end of the consultation sessions
Method of measurement
Use of Social maturity of Vineland scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group, in addition to routine child care training and delivery of training packages, 6 sessions that are 30 minutes and weekly 2 sessions of group consultancy of play therapy will be held
Category
Behavior
2
Description
Control group:they will receive ministry’s routine training and training packages.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan health center (1)
Full name of responsible person
Dr. Zohreh Mahmoodi
Street address
Imam Reza Square, Phase 2 of Naji Abad, Comprehensive Health Services Center No. 1
City
Kashan
Province
Isfehan
Postal code
8719336365
Phone
+98 31 5542 9357
Email
health@kaums.ac.ir
2
Recruitment center
Name of recruitment center
Kashan Center for Comprehensive Health Services No. 2
Full name of responsible person
Dr Zohreh Mahmoodi
Street address
Amir Kabir Ave. Matini Hospital - Health Services Center No. 2
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
+98 31 5533 1136
Email
health@kaums.ac.ir
3
Recruitment center
Name of recruitment center
Kashan Center for Comprehensive Health Services No. 3
Full name of responsible person
Dr. Zohreh Mahmoodi
Street address
Teachers' Square, Bahonar Blvd, Health Services Center No. 3
City
Kashan
Province
Isfehan
Postal code
8714873398
Phone
+98 31 5554 0503
Email
health@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Azam Bagheri
Street address
Department of Nursing,Kashan University Of Medical Science,GHotbe Ravandi Blvd,Kashan
City
kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Email
asambagheri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alborz University Of Medical 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
Alborz University Of Medical Sciences
Full name of responsible person
Dr Zohreh Mahmoodi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Nursing,Alborz University Of Medical Science,Eshteraki St,Baghestan Blv Karaj,Karaj
City
Karaj
Province
Alborz
Postal code
561-31452
Phone
+98 26 3455 1034
Email
zohrehmahmoodi2011@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University Of Medical Sciences
Full name of responsible person
Dr Zohreh Mahmoodi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Nursing,Alborz University of Medical Science,Eshteraki St,Baghestan Blv Karaj,Karaj
City
Karaj
Province
Alborz
Postal code
561-31452
Phone
+98 26 3455 1034
Email
zohrehmahmoodi2011@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University Of Medical Sciences
Full name of responsible person
Dr Zohreh Mahmoodi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Nursing,Alborz University Of Medical Science,Eshteraki St,Baghestan Blv Karaj,Karaj
City
Karaj
Province
Alborz
Postal code
561-31452
Phone
+98 264551034
Email
zohrehmahmoodi2011@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
as an English article we published data.
When the data will become available and for how long
10 month later
To whom data/document is available
Alborz & Kashan University Of Nursing and Midwifery
Under which criteria data/document could be used
Path analysis
From where data/document is obtainable
Dr Zohreh Mahmoodi
What processes are involved for a request to access data/document